Coronary Artery DiseasePhase 1NCT03420092
A Study to Assess the Bioavailability of Different Formulations of AZD5718 and the Food Effect on the Selected Formulation of AZD5718 in Healthy Volunteers
A Phase 1 study testing Form 1 of AZD5718 tablets, Form 2 of AZD5718 tablets and Form 3 of AZD5718 tablets in people with Coronary Artery Disease, run by AstraZeneca at 1 site in United Kingdom.
Trial summary
In this study, the relative bioavailability of different formulations of AZD5718 will be determined in order to compare it with the formulation used in a previous Phase 2a study and confirm appropriate drug exposure. This study consist of 2 parts. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Form 1 of AZD5718 tablets, Form 2 of AZD5718 tablets and Form 3 of AZD5718 tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 5 Feb 2018to 18 Apr 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Provision of signed and dated, written informed consent before any study specific procedures.
- Healthy male and/or female subjects aged 18 to 55 years (inclusive) with suitable veins for cannulation or repeated venipuncture.
- Females must have a negative pregnancy test at screening and on admission to the unit, must not be lactating and must be of non childbearing potential, confirmed at screening by fulfilling one of the following criteria 3.1. Postmenopausal defined as amenorrhoea for at least 12 months or more following cessation of all exogenous hormonal treatments and follicle stimulating hormone (FSH) levels in the postmenopausal range.
- 3.2. Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation.
- Have a body mass index (BMI) between 18 and 30 kg/m2 inclusive and weigh at least 50 kg and no more than 100 kg inclusive.
- Provision of signed, written and dated informed consent for optional genetic/biomarker research. If a subject declines to participate in the genetic component of the study, there will be no penalty or loss of benefit to the subject. The subject will not be excluded from other aspects of the study described in this protocol.
Who cannot join
- History of any clinically significant disease or disorder which, in the opinion of the PI, may either put the volunteer at-risk because of participation in the study, or influence the results or the volunteer's ability to participate in the study.
- History or presence of gastrointestinal (GI), hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs.
- Participants with any special dietary restrictions such as subjects that are lactose intolerant or are vegetarians/vegans.
- Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of IMP.
- Any clinically significant abnormalities in clinical chemistry, hematology or urinalysis results, at screening and/or admission to the study unit as judged by the PI.
- Any clinically significant abnormal findings in vital signs at screening, as judged by the PI.
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- Any clinically significant abnormalities on 12-lead ECG at screening and/or admission to the study unit, as judged by the PI.
- Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody, and human immunodeficiency virus (HIV) antibody.
- Known of suspected Gilbert's syndrome and known or suspected history of drug abuse, as judged by the PI.
- Has received another new chemical or biological entity (defined as a compound which has not been approved for marketing) within 3 months of the first administration of IMP in this study. The period of exclusion begins 3 months after the final dose or one month after the last visit whichever is the longest.
- Note: Participants consented and screened, but not randomized in this study or a previous phase I study, are not excluded.
- Plasma donation within 1 month of screening or any blood donation/loss more than 500 mL during the 3 months before screening.
- History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the PI or history of hypersensitivity to drugs with a similar chemical structure or class to AZD5718.
- Current smokers or those who have smoked or used nicotine products (including e-cigarettes) within the 3 months before screening.
- Positive screen for drugs of abuse or cotinine (screening only) at screening or on each admission to the study center or positive screen for alcohol on each admission to the study center.
- Use of drugs with enzyme-inducing properties such as St John's Wort within 3 weeks before the first administration of IMP.
- Use of any prescribed or non prescribed medication including antacids, analgesics (other than paracetamol/acetaminophen), herbal remedies, megadose vitamins (intake of 20 to 600 times the recommended daily dose) and minerals during the 2 weeks before the first administration of IMP or longer if the medication has a long half life.
- Known or suspected history of alcohol or drug abuse or excessive intake of alcohol as judged by the PI.
- Involvement of any AstraZeneca, PAREXEL or study site employee or their close relatives.
- Subjects who have previously received AZD5718.
- Judgment by the PI that the subject should not participate in the study if they have any ongoing or recent minor medical complaints that may interfere with the interpretation of study data or are considered unlikely to comply with study procedures, restrictions and requirements.
- Vulnerable subjects, e.g., kept in detention, protected adults under guardianship.
- Non-leukocyte depleted whole blood transfusion within 120 days of the date of the genetic sample collection or previous bone marrow transplant.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, 6-period, 6-treatment, Single-dose, Open-label, Single-center, Crossover Study to Assess the Relative Bioavailability of Different Formulations of AZD5718 and the Food Effect on the Selected Formulation of AZD5718 in Healthy Volunteers
In this study, the relative bioavailability of different formulations of AZD5718 will be determined in order to compare it with the formulation used in a previous Phase 2a study and confirm appropriate drug exposure. This study consist of 2 parts. In Part 1, 5 different formulations of AZD5718 would be provided to the participant in fasting condition in a randomized order. After evaluation of Part 1 a single formulation would be selected for dosing in fed condition in Part 2. Each participant will be involved in the study for approximately 5 to 6 weeks. Fourteen participants will be randomized to ensure at least 10 evaluable participants at the end of the last treatment period.
Read the detailed description
This is a Randomized, 6-period, 6-treatment, Single-dose, Open-label, Single-center, Crossover, phase I Study to Assess the Relative Bioavailability of Different Formulations of AZD5718 and the Food Effect on the Selected Formulation of AZD5718 in Healthy Volunteers. In this study, the relative bioavailability of different formulations of AZD5718 will be determined in order to compare it with the formulation used in a previous Phase 2a study and confirm appropriate drug exposure. The optimal pharmacokinetic (PK) profile of AZD5718 is currently not known but working hypothesis is that a flatter PK profile will deliver the same efficacy at a lower dose/exposure compared to a fluctuating AZD5718 profile. Thus, formulations with different release rates will be evaluated. Potential food effect of a selected formulation would be determined in order to provide appropriate dose and dosing instructions for further development of AZD5718. This study would consist of 2 parts. In Part 1, 5 different formulations of AZD5718 would be provided to the participants in fasting condition in a randomized order. After evaluation of Part 1 a single formulation would be selected for dosing in fed condition in Part 2. Part 1 of the study will be an open-label, randomized, 5-period, 5-treatment, single dose crossover study in 14 healthy participants (males and females of non-childbearing potential), performed at a single study center to ensure that at least 10 participants are evaluable. Each participant would be randomized to 1 of 10 treatment sequence according to a Williams design to receive the 5 treatments as following: Form 1 of AZD5718 tablets, Treatment B: Form 2 of AZD5718 tablets, Treatment C: Form 3 of AZD5718 tablets, Treatment D: Form 4 of AZD5718 tablets, and Treatment E: Form 5 of AZD5718 tablets. Participants will receive 1 treatment per treatment period. During each treatment period, participants would be dosed following an overnight fast of at least 10 hours. No fluids will be allowed apart from water which can be given until 2 hours before administration of the investigational medicinal product (IMP) and then from 1 hours after administration of the IMP. The dose would be administered with 240 mL of water. A standard meal would be given 4 hours after administration of the IMP. Participants should not lie fully supine (unless specified for certain assessments) for 4 hours after dosing. After completion the PK evaluation in Part 1, the formulation for Part 2 would be selected. At least 10 participants from Part 1 will be included in Part 2, to ensure that at least 8 participants are evaluable. For each participant included in Part 2, there would be minimum period of at least 2 weeks between the last dose of IMP in Part 1 and the dose of IMP in Part 2. During the treatment period in Part 2, participants would be dosed with the selected formulation of IMP with food. Participants would fast at least 10 hours prior to receiving the test meal. Participants should start the recommended meal 30 minutes prior to administration of the IMP. Participants would be required to consume the meal in 25 minutes; however, the IMP should be administered 30 minutes after start of the meal with 240 mL of water. No fluids would be allowed apart from water which can be given until 1 hour before administration of the IMP and then from 2 hours after administration of the IMP. Each participant will be involved in the study for approximately 5 to 6 weeks.
- Conditions
- Coronary Artery Disease
- Being tested
- Form 1 of AZD5718 tablets, Form 2 of AZD5718 tablets, Form 3 of AZD5718 tablets, Form 4 of AZD5718 tablets, Form 5 of AZD5718 tablets
- Keywords
- vasoactive leukotrienes by leukocytes, bioavailability
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Form 1 of AZD5718 tabletsDrug
The participants will be dosed with Form 1 of AZD5718 following an overnight fast of at least 10 hours.
Form 2 of AZD5718 tabletsDrug
The participants will be dosed with Form 2 of AZD5718 following an overnight fast of at least 10 hours.
Form 3 of AZD5718 tabletsDrug
The participants will be dosed with Form 3 of AZD5718 following an overnight fast of at least 10 hours.
Form 4 of AZD5718 tabletsDrug
The participants will be dosed with Form 4 of AZD5718 following an overnight fast of at least 10 hours.
Form 5 of AZD5718 tabletsDrug
The participants will be dosed with Form 5 of AZD5718 following an overnight fast of at least 10 hours.
Selected form (Form 2 - 5) of AZD5718 tabletsDrug
The participant will be administered with selected form (one of Form 2-5) of AZD5718 tablets 30 minutes after start of the meal.
| Study group | Role | What they receive |
|---|---|---|
| Treatment A | Experimental | The participant will be administered with Form 1 of AZD5718 tablets with an overnight fast of at least 10 hours. Receives: Drug: Form 1 of AZD5718 tablets |
| Treatment B | Experimental | The participant will be administered with Form 2 of AZD5718 tablets with an overnight fast of at least 10 hours. Receives: Drug: Form 2 of AZD5718 tablets |
| Treatment C | Experimental | The participant will be administered with Form 3 of AZD5718 tablets with an overnight fast of at least 10 hours. Receives: Drug: Form 3 of AZD5718 tablets |
| Treatment D | Experimental | The participant will be administered with Form 4 of AZD5718 tablets with an overnight fast of at least 10 hours. Receives: Drug: Form 4 of AZD5718 tablets |
| Treatment E | Experimental | The participant will be administered with Form 5 of AZD5718 tablets with an overnight fast of at least 10 hours. Receives: Drug: Form 5 of AZD5718 tablets |
| Treatment F | Experimental | The participant will be administered with selected form (one of Form 2-5) of AZD5718 tablets 30 minutes after start of the meal. Receives: Drug: Selected form (Form 2 - 5) of AZD5718 tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under plasma concentration-time curve (AUC) of AZD5718
To assess the pharmacokinetics (PK) parameter AUC to evaluate the relative bioavailability of different formulations of AZD5718 and compare with the formulation (Form 1 of AZD5718 tablets) used in the Phase 2a clinical study.
Measured: At pre dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36 and 48 hours post dose.
AUC from time zero to time of last quantifiable concentration (AUC[0-t]) of AZD5718
To assess the PK parameter AUC(0-t)to evaluate the relative bioavailability of different formulations of AZD5718 and compare with the formulation (Form 1 of AZD5718 tablets) used in the Phase 2a clinical study.
Measured: At pre dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36 and 48 hours post dose.
Observed maximum plasma concentration (Cmax) of AZD5718
To assess the PK parameter Cmax to evaluate the relative bioavailability of different formulations of AZD5718 and compare with the formulation (Form 1 of AZD5718 tablets) used in the Phase 2a clinical study.
Measured: At pre dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36 and 48 hours post dose.
Observed plasma concentration at 24 hours post dose (C24) of AZD5718
To assess the PK parameter C24 to evaluate the relative bioavailability of different formulations of AZD5718 and compare with the formulation (Form 1 of AZD5718 tablets) used in the Phase 2a clinical study.
Measured: 24 hour post dose
Secondary outcomes (49)
Cmax of AZD5718 in fed and fasted conditions
To assess the ratio of Cmax of a selected AZD5718 formulation when administered in fed and fasted conditions and relative bioavailability of the tested formulations.
Measured: At pre dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36 and 48 hours post dose.
C24 of AZD5718 in fed and fasted conditions
To assess the ratio of C24 of a selected AZD5718 formulation when administered in fed and fasted conditions and relative bioavailability of the tested formulations.
Measured: At pre dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36 and 48 hours post dose.
AUC(0-t) of AZD5718 in fed and fasted conditions
To assess the ratio of AUC(0-t) of a selected AZD5718 formulation when administered in fed and fasted conditions and relative bioavailability of the tested formulations.
Measured: At pre dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36 and 48 hours post dose.
AUC of AZD5718 in fed and fasted conditions
To assess the ratio of AUC of a selected AZD5718 formulation when administered in fed and fasted conditions and relative bioavailability of the tested formulations.
Measured: At pre dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36 and 48 hours post dose.
Number of participants with adverse events
All adverse events will be coded using MedDRA vocabulary, and will be listed for each subject.
Measured: From randomization throughout the treatment period (Day 1 to 3) and follow-up Visit (Day 5 to 7) assessed maximum upto 6 weeks.
Assessment of systolic blood pressure
To assess the systolic blood pressure as a criteria of safety and tolerability.
Measured: [Part 1 - At screening (From Day -28 to Day-2); Treatment period 1 (Day-1), Treatment period 1 to 5 (Day 1 to 3)] and [Part 2- At Day-1, Day 1 to 3, 5 to 7 days post final dose].
Assessment of diastolic blood pressure
To assess the Diastolic blood pressure as a criteria of safety and tolerability.
Measured: [Part 1 - At screening (From Day -28 to Day-2); Treatment period 1 (Day-1), Treatment period 1 to 5 (Day 1 to 3)] and [Part 2- At Day-1, Day 1 to 3, 5 to 7 days post final dose].
Assessment of pulse rate
To assess Pulse rate as a criteria of safety and tolerability.
Measured: [Part 1 - At screening (From Day -28 to Day-2); Treatment period 1 (Day-1), Treatment period 1 to 5 (Day 1 to 3)] and [Part 2- At Day-1, Day 1 to 3, 5 to 7 days post final dose].
Assessment of 12-lead electrocardiogram (ECG)
To assess the ECG as a criteria of safety and tolerability. A 10 second 12 lead ECG will be obtained after 10 minutes supine rest.
Measured: At screening (From Day -28 to Day -2 - Part 1); 5 to 7 days post final dose (Part 2).
Assessment of physical examination
Assessment of physical examinations will include an assessment of the general appearance, respiratory, cardiovascular, abdomen, skin, head, and neck (including ears, eyes, nose, and throat), lymph nodes, thyroid, musculoskeletal and neurological systems.
Measured: [Part 1 - At screening (From Day -28 to Day-2); Treatment period 1 (Day-1), Treatment period 1 to 5 (Day 1 to 3)] and [Part 2- At Day-1, Day 1 to 3, 5 to 7 days post final dose].
Half-life associated with terminal slope (λz) of a semi-logarithmic concentration-time curve (t½λz) of AZD5718
To assess PK parameter t½λz to evaluate the relative bioavailability of different formulations of AZD5718 and compare with the formulation (Form 1 of AZD5718 tablets) used in the Phase 2a clinical study.
Measured: At pre dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36 and 48 hours post dose.
Time to reach maximum observed plasma concentration (Tmax) of AZD5718
To assess the PK parameter Tmax to evaluate the relative bioavailability of different formulations of AZD5718 and compare with the formulation (Form 1 of AZD5718 tablets) used in the Phase 2a clinical study.
Measured: At pre dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36 and 48 hours post dose.
Apparent total body clearance of drug from plasma after extravascular administration (CL/F) of AZD5718
To assess the PK parameter CL/F to evaluate the relative bioavailability of different formulations of AZD5718 and compare with the formulation (Form 1 of AZD5718 tablets) used in the Phase 2a clinical study.
Measured: At pre dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36 and 48 hours post dose.
Safety and tolerability of AZD5718 by assessment of clinical Laboratory evaluations (Hematology)- white blood cell (WBC) count
Safety and tolerability of AZD5718 by assessment of WBC count.
Measured: [Part 1 - At screening (From Day -28 to Day-2); Treatment period 1 (Day-1), Treatment period 1 to 5 (Day 1 to 3)] and [Part 2- At Day-1, Day 1 to 3, 5 to 7 days post final dose]
Safety and tolerability of AZD5718 by assessment of clinical Laboratory evaluations (hematology)- red blood cell (RBC) count
Safety and tolerability of AZD5718 by assessment of RBC count.
Measured: [Part 1 - At screening (From Day -28 to Day-2); Treatment period 1 (Day-1), Treatment period 1 to 5 (Day 1 to 3)] and [Part 2- At Day-1, Day 1 to 3, 5 to 7 days post final dose]
Safety and tolerability of AZD5718 by assessment of clinical Laboratory evaluations (hematology)- haemoglobin (HB)
Safety and tolerability of AZD5718 by assessment of HB.
Measured: [Part 1 - At screening (From Day -28 to Day-2); Treatment period 1 (Day-1), Treatment period 1 to 5 (Day 1 to 3)] and [Part 2- At Day-1, Day 1 to 3, 5 to 7 days post final dose]
Safety and tolerability of AZD5718 by assessment of clinical Laboratory evaluations (hematology)- hematocrit (HCT)
Safety and tolerability of AZD5718 by assessment of HCT.
Measured: [Part 1 - At screening (From Day -28 to Day-2); Treatment period 1 (Day-1), Treatment period 1 to 5 (Day 1 to 3)] and [Part 2- At Day-1, Day 1 to 3, 5 to 7 days post final dose]
Safety and tolerability of AZD5718 by assessment of clinical Laboratory evaluations (hematology)- platelets
Safety and tolerability of AZD5718 by assessment of platelets.
Measured: [Part 1 - At screening (From Day -28 to Day-2); Treatment period 1 (Day-1), Treatment period 1 to 5 (Day 1 to 3)] and [Part 2- At Day-1, Day 1 to 3, 5 to 7 days post final dose]
Safety and tolerability of AZD5718 by assessment of clinical Laboratory evaluations (hematology)- reticulocytes absolute count
Safety and tolerability of AZD5718 by assessment of reticulocytes absolute count.
Measured: [Part 1 - At screening (From Day -28 to Day-2); Treatment period 1 (Day-1), Treatment period 1 to 5 (Day 1 to 3)] and [Part 2- At Day-1, Day 1 to 3, 5 to 7 days post final dose]
Safety and tolerability of AZD5718 by assessment of clinical Laboratory evaluations (hematology)- mean corpuscular hemoglobin (MCH)
Safety and tolerability of AZD5718 by assessment of MCH.
Measured: [Part 1 - At screening (From Day -28 to Day-2); Treatment period 1 (Day-1), Treatment period 1 to 5 (Day 1 to 3)] and [Part 2- At Day-1, Day 1 to 3, 5 to 7 days post final dose]
Safety and tolerability of AZD5718 by assessment of clinical Laboratory evaluations (hematology)- mean corpuscular hemoglobin concentration (MCHC)
Safety and tolerability of AZD5718 by assessment of MCHC.
Measured: [Part 1 - At screening (From Day -28 to Day-2); Treatment period 1 (Day-1), Treatment period 1 to 5 (Day 1 to 3)] and [Part 2- At Day-1, Day 1 to 3, 5 to 7 days post final dose]
Safety and tolerability of AZD5718 by assessment of clinical laboratory evaluations (clinical chemistry)- creatinine
Safety and tolerability of AZD5718 by assessment of creatinine.
Measured: [Part 1 - At screening (From Day -28 to Day-2); Treatment period 1 (Day-1), Treatment period 1 to 5 (Day 1 to 3)] and [Part 2- At Day-1, Day 1 to 3, 5 to 7 days post final dose]
Safety and tolerability of AZD5718 by assessment of clinical laboratory evaluations (clinical chemistry)- creatine kinase
Safety and tolerability of AZD5718 by assessment of creatine kinase.
Measured: [Part 1 - At screening (From Day -28 to Day-2); Treatment period 1 (Day-1), Treatment period 1 to 5 (Day 1 to 3)] and [Part 2- At Day-1, Day 1 to 3, 5 to 7 days post final dose]
Safety and tolerability of AZD5718 by assessment of clinical laboratory evaluations (clinical chemistry)- total bilirubin
Safety and tolerability of AZD5718 by assessment of total bilirubin.
Measured: [Part 1 - At screening (From Day -28 to Day-2); Treatment period 1 (Day-1), Treatment period 1 to 5 (Day 1 to 3)] and [Part 2- At Day-1, Day 1 to 3, 5 to 7 days post final dose]
Safety and tolerability of AZD5718 by assessment of clinical laboratory evaluations (clinical chemistry)- unconjugated bilirubin
Safety and tolerability of AZD5718 by assessment of unconjugated bilirubin.
Measured: [Part 1 - At screening (From Day -28 to Day-2); Treatment period 1 (Day-1), Treatment period 1 to 5 (Day 1 to 3)] and [Part 2- At Day-1, Day 1 to 3, 5 to 7 days post final dose]
Safety and tolerability of AZD5718 by assessment of clinical laboratory evaluations (clinical chemistry)- alkaline phosphatase
Safety and tolerability of AZD5718 by assessment of alkaline phosphatase.
Measured: [Part 1 - At screening (From Day -28 to Day-2); Treatment period 1 (Day-1), Treatment period 1 to 5 (Day 1 to 3)] and [Part 2- At Day-1, Day 1 to 3, 5 to 7 days post final dose]
Safety and tolerability of AZD5718 by assessment of clinical laboratory evaluations (clinical chemistry)- aspartate aminotransferase (AST)
Safety and tolerability of AZD5718 by assessment of AST.
Measured: [Part 1 - At screening (From Day -28 to Day-2); Treatment period 1 (Day-1), Treatment period 1 to 5 (Day 1 to 3)] and [Part 2- At Day-1, Day 1 to 3, 5 to 7 days post final dose]
Safety and tolerability of AZD5718 by assessment of clinical laboratory evaluations (clinical chemistry)- gamma glutamyl transpeptidase (GGT)
Safety and tolerability of AZD5718 by assessment of GGT.
Measured: [Part 1 - At screening (From Day -28 to Day-2); Treatment period 1 (Day-1), Treatment period 1 to 5 (Day 1 to 3)] and [Part 2- At Day-1, Day 1 to 3, 5 to 7 days post final dose]
Safety and tolerability of AZD5718 by assessment of clinical laboratory evaluations (clinical chemistry)- albumin
Safety and tolerability of AZD5718 by assessment of albumin.
Measured: [Part 1 - At screening (From Day -28 to Day-2); Treatment period 1 (Day-1), Treatment period 1 to 5 (Day 1 to 3)] and [Part 2- At Day-1, Day 1 to 3, 5 to 7 days post final dose]
Safety and tolerability of AZD5718 by assessment of clinical laboratory evaluations (clinical chemistry)- potassium
Safety and tolerability of AZD5718 by assessment of potassium.
Measured: [Part 1 - At screening (From Day -28 to Day-2); Treatment period 1 (Day-1), Treatment period 1 to 5 (Day 1 to 3)] and [Part 2- At Day-1, Day 1 to 3, 5 to 7 days post final dose]
Safety and tolerability of AZD5718 by assessment of clinical laboratory evaluations (clinical chemistry)- sodium
Safety and tolerability of AZD5718 by assessment of sodium.
Measured: [Part 1 - At screening (From Day -28 to Day-2); Treatment period 1 (Day-1), Treatment period 1 to 5 (Day 1 to 3)] and [Part 2- At Day-1, Day 1 to 3, 5 to 7 days post final dose]
Safety and tolerability of AZD5718 by assessment of clinical Laboratory evaluations (clinical chemistry)- calcium
Safety and tolerability of AZD5718 by assessment of calcium.
Measured: [Part 1 - At screening (From Day -28 to Day-2); Treatment period 1 (Day-1), Treatment period 1 to 5 (Day 1 to 3)] and [Part 2- At Day-1, Day 1 to 3, 5 to 7 days post final dose]
Safety and tolerability of AZD5718 by assessment of clinical laboratory evaluations (clinical chemistry)- C-reactive protein
Safety and tolerability of AZD5718 by assessment of C-reactive protein.
Measured: [Part 1 - At screening (From Day -28 to Day-2); Treatment period 1 (Day-1), Treatment period 1 to 5 (Day 1 to 3)] and [Part 2- At Day-1, Day 1 to 3, 5 to 7 days post final dose]
Safety and tolerability of AZD5718 by assessment of clinical Laboratory evaluations (clinical chemistry)- urea
Safety and tolerability of AZD5718 by assessment of urea.
Measured: [Part 1 - At screening (From Day -28 to Day-2); Treatment period 1 (Day-1), Treatment period 1 to 5 (Day 1 to 3)] and [Part 2- At Day-1, Day 1 to 3, 5 to 7 days post final dose]
Safety and tolerability of AZD5718 by assessment of clinical laboratory evaluations (clinical chemistry)- phosphate
Safety and tolerability of AZD5718 by assessment of phosphate.
Measured: [Part 1 - At screening (From Day -28 to Day-2); Treatment period 1 (Day-1), Treatment period 1 to 5 (Day 1 to 3)] and [Part 2- At Day-1, Day 1 to 3, 5 to 7 days post final dose]
Safety and tolerability of AZD5718 by assessment of clinical laboratory evaluations (clinical chemistry)- glucose (fasting)
Safety and tolerability of AZD5718 by assessment of glucose (fasting).
Measured: [Part 1 - At screening (From Day -28 to Day-2); Treatment period 1 (Day-1), Treatment period 1 to 5 (Day 1 to 3)] and [Part 2- At Day-1, Day 1 to 3, 5 to 7 days post final dose]
Safety and tolerability of AZD5718 by assessment of clinical laboratory evaluations- urinalysis (blood)
Safety and tolerability of AZD5718 by assessment of urinalysis (blood). If urinalysis is positive for blood, a microscopy test will be performed to assess RBC, white blood cell [WBC], casts [cellular, granular, hyaline]).
Measured: [Part 1 - At screening (From Day -28 to Day-2); Treatment period 1 (Day-1), Treatment period 1 to 5 (Day 1 to 3)] and [Part 2- At Day-1, Day 1 to 3, 5 to 7 days post final dose]
Safety and tolerability of AZD5718 by assessment of clinical laboratory evaluations- urinalysis (glucose)
Safety and tolerability of AZD5718 by assessment of urinalysis (glucose).
Measured: [Part 1 - At screening (From Day -28 to Day-2); Treatment period 1 (Day-1), Treatment period 1 to 5 (Day 1 to 3)] and [Part 2- At Day-1, Day 1 to 3, 5 to 7 days post final dose]
Safety and tolerability of AZD5718 by assessment of clinical laboratory evaluations (hematology)- Mean corpuscular volume (MCV)
Safety and tolerability of AZD5718 by assessment of MCV.
Measured: [Part 1 - At screening (From Day -28 to Day-2); Treatment period 1 (Day-1), Treatment period 1 to 5 (Day 1 to 3)] and [Part 2- At Day-1, Day 1 to 3, 5 to 7 days post final dose]
Safety and tolerability of AZD5718 by assessment of clinical laboratory evaluations (clinical chemistry)- Alanine aminotransferase (ALT)
Safety and tolerability of AZD5718 by assessment of ALT
Measured: [Part 1 - At screening (From Day -28 to Day-2); Treatment period 1 (Day-1), Treatment period 1 to 5 (Day 1 to 3)] and [Part 2- At Day-1, Day 1 to 3, 5 to 7 days post final dose]
Safety and tolerability of AZD5718 by assessment of clinical laboratory evaluations (clinical chemistry)- Thyroxine 4 (T4)
Safety and tolerability of AZD5718 by assessment of T4.
Measured: At screening (From Day -28 to Day-2)
Safety and tolerability of AZD5718 by assessment of clinical laboratory evaluations(clinical chemistry)- Thyroid stimulating hormone (TSH)
Safety and tolerability of AZD5718 by assessment of TSH.
Measured: At screening (From Day -28 to Day-2)
Safety and tolerability of AZD5718 by assessment of clinical laboratory evaluations(clinical chemistry)- Follicle stimulating hormone (FSH)
Safety and tolerability of AZD5718 by assessment of FSH in female participants.
Measured: [Part 1 - At screening (From Day -28 to Day-2); Treatment period 1 (Day-1), Treatment period 1 to 5 (Day 1 to 3)] and [Part 2- At Day-1, Day 1 to 3, 5 to 7 days post final dose]
Safety and tolerability of AZD5718 by assessment of clinical laboratory evaluations (hematology)- Neutrophils absolute count
Safety and tolerability of AZD5718 by assessment of neutrophils absolute count.
Measured: [Part 1 - At screening (From Day -28 to Day-2); Treatment period 1 (Day-1), Treatment period 1 to 5 (Day 1 to 3)] and [Part 2- At Day-1, Day 1 to 3, 5 to 7 days post final dose]
Safety and tolerability of AZD5718 by assessment of clinical laboratory evaluations (hematology)- Lymphocytes absolute count
Safety and tolerability of AZD5718 by assessment of lymphocytes absolute count.
Measured: [Part 1 - At screening (From Day -28 to Day-2); Treatment period 1 (Day-1), Treatment period 1 to 5 (Day 1 to 3)] and [Part 2- At Day-1, Day 1 to 3, 5 to 7 days post final dose]
Safety and tolerability of AZD5718 by assessment of clinical laboratory evaluations (hematology)- Monocytes absolute count
Safety and tolerability of AZD5718 by assessment of monocytes absolute count.
Measured: [Part 1 - At screening (From Day -28 to Day-2); Treatment period 1 (Day-1), Treatment period 1 to 5 (Day 1 to 3)] and [Part 2- At Day-1, Day 1 to 3, 5 to 7 days post final dose]
Safety and tolerability of AZD5718 by assessment of clinical laboratory evaluations (hematology)- Basophils absolute count
Safety and tolerability of AZD5718 by assessment of basophils absolute count.
Measured: [Part 1 - At screening (From Day -28 to Day-2); Treatment period 1 (Day-1), Treatment period 1 to 5 (Day 1 to 3)] and [Part 2- At Day-1, Day 1 to 3, 5 to 7 days post final dose]
Safety and tolerability of AZD5718 by assessment of clinical laboratory evaluations- urinalysis (protein)
Safety and tolerability of AZD5718 by assessment of urinalysis (protein). If urinalysis is positive for protein, a microscopy test will be performed to assess RBC, WBC, casts [cellular, granular, hyaline]).
Measured: [Part 1 - At screening (From Day -28 to Day-2); Treatment period 1 (Day-1), Treatment period 1 to 5 (Day 1 to 3)] and [Part 2- At Day-1, Day 1 to 3, 5 to 7 days post final dose]
Safety and tolerability of AZD5718 by assessment of clinical laboratory evaluations (hematology)- Eosinophils absolute count
Safety and tolerability of AZD5718 by assessment of eosinophils absolute count.
Measured: [Part 1 - At screening (From Day -28 to Day-2); Treatment period 1 (Day-1), Treatment period 1 to 5 (Day 1 to 3)] and [Part 2- At Day-1, Day 1 to 3, 5 to 7 days post final dose]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2018
- Study start5 Feb 2018
- Primary completion18 Apr 2018
- Study completion18 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Parexel
- Responsible party
- Sponsor
- Investigators
- Pablo Forte Soto, MD, Principal investigator, PAREXEL Early Phase Clinical Unit London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03420092
- Sponsor's protocol ID
- D7550C00005
- Status last verified
- Apr 2018
- First submitted
- 18 Jan 2018
- Last updated
- 23 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, 6-period, 6-treatment, Single-dose, Open-label, Single-center, Crossover Study to Assess the Relative Bioavailability of Different Formulations of AZD5718 and the Food Effect on the Selected Formulation of AZD5718 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT03420092
- Acronym / sponsor ID
- D7550C00005
- Conditions
- Coronary Artery Disease
- Keywords
- vasoactive leukotrienes by leukocytes, bioavailability
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Parexel
- Study start
- 5 Feb 2018 (actual)
- Primary completion
- 18 Apr 2018 (actual)
- Study completion
- 18 Apr 2018 (actual)
- First posted
- 5 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study, the relative bioavailability of different formulations of AZD5718 will be determined in order to compare it with the formulation used in a previous Phase 2a study and confirm appropriate drug exposure. This study consist of 2 parts. In Part 1, 5 different formulations of AZD5718 would be provided to the participant in fasting condition in a randomized order. After evaluation of Part 1 a single formulation would be selected for dosing in fed condition in Part 2. Each participant will be involved in the study for approximately 5 to 6 weeks. Fourteen participants will be randomized to ensure at least 10 evaluable participants at the end of the last treatment period.
Detailed description
This is a Randomized, 6-period, 6-treatment, Single-dose, Open-label, Single-center, Crossover, phase I Study to Assess the Relative Bioavailability of Different Formulations of AZD5718 and the Food Effect on the Selected Formulation of AZD5718 in Healthy Volunteers. In this study, the relative bioavailability of different formulations of AZD5718 will be determined in order to compare it with the formulation used in a previous Phase 2a study and confirm appropriate drug exposure. The optimal pharmacokinetic (PK) profile of AZD5718 is currently not known but working hypothesis is that a flatter PK profile will deliver the same efficacy at a lower dose/exposure compared to a fluctuating AZD5718 profile. Thus, formulations with different release rates will be evaluated. Potential food effect of a selected formulation would be determined in order to provide appropriate dose and dosing instructions for further development of AZD5718. This study would consist of 2 parts. In Part 1, 5 different formulations of AZD5718 would be provided to the participants in fasting condition in a randomized order. After evaluation of Part 1 a single formulation would be selected for dosing in fed condition in Part 2. Part 1 of the study will be an open-label, randomized, 5-period, 5-treatment, single dose crossover study in 14 healthy participants (males and females of non-childbearing potential), performed at a single study center to ensure that at least 10 participants are evaluable. Each participant would be randomized to 1 of 10 treatment sequence according to a Williams design to receive the 5 treatments as following: Form 1 of AZD5718 tablets, Treatment B: Form 2 of AZD5718 tablets, Treatment C: Form 3 of AZD5718 tablets, Treatment D: Form 4 of AZD5718 tablets, and Treatment E: Form 5 of AZD5718 tablets. Participants will receive 1 treatment per treatment period. During each treatment period, participants would be dosed following an overnight fast of at least 10 hours. No fluids will be allowed apart from water which can be given until 2 hours before administration of the investigational medicinal product (IMP) and then from 1 hours after administration of the IMP. The dose would be administered with 240 mL of water. A standard meal would be given 4 hours after administration of the IMP. Participants should not lie fully supine (unless specified for certain assessments) for 4 hours after dosing. After completion the PK evaluation in Part 1, the formulation for Part 2 would be selected. At least 10 participants from Part 1 will be included in Part 2, to ensure that at least 8 participants are evaluable. For each participant included in Part 2, there would be minimum period of at least 2 weeks between the last dose of IMP in Part 1 and the dose of IMP in Part 2. During the treatment period in Part 2, participants would be dosed with the selected formulation of IMP with food. Participants would fast at least 10 hours prior to receiving the test meal. Participants should start the recommended meal 30 minutes prior to administration of the IMP. Participants would be required to consume the meal in 25 minutes; however, the IMP should be administered 30 minutes after start of the meal with 240 mL of water. No fluids would be allowed apart from water which can be given until 1 hour before administration of the IMP and then from 2 hours after administration of the IMP. Each participant will be involved in the study for approximately 5 to 6 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Experimental | Drug: Form 1 of AZD5718 tabletsThe participant will be administered with Form 1 of AZD5718 tablets with an overnight fast of at least 10 hours. |
| Treatment B | Experimental | Drug: Form 2 of AZD5718 tabletsThe participant will be administered with Form 2 of AZD5718 tablets with an overnight fast of at least 10 hours. |
| Treatment C | Experimental | Drug: Form 3 of AZD5718 tabletsThe participant will be administered with Form 3 of AZD5718 tablets with an overnight fast of at least 10 hours. |
| Treatment D | Experimental | Drug: Form 4 of AZD5718 tabletsThe participant will be administered with Form 4 of AZD5718 tablets with an overnight fast of at least 10 hours. |
| Treatment E | Experimental | Drug: Form 5 of AZD5718 tabletsThe participant will be administered with Form 5 of AZD5718 tablets with an overnight fast of at least 10 hours. |
| Treatment F | Experimental | Drug: Selected form (Form 2 - 5) of AZD5718 tabletsThe participant will be administered with selected form (one of Form 2-5) of AZD5718 tablets 30 minutes after start of the meal. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Provision of signed and dated, written informed consent before any study specific procedures.
- Healthy male and/or female subjects aged 18 to 55 years (inclusive) with suitable veins for cannulation or repeated venipuncture.
- Females must have a negative pregnancy test at screening and on admission to the unit, must not be lactating and must be of non childbearing potential, confirmed at screening by fulfilling one of the following criteria 3.1. Postmenopausal defined as amenorrhoea for at least 12 months or more following cessation of all exogenous hormonal treatments and follicle stimulating hormone (FSH) levels in the postmenopausal range.
- 3.2. Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation.
- Have a body mass index (BMI) between 18 and 30 kg/m2 inclusive and weigh at least 50 kg and no more than 100 kg inclusive.
Key exclusion criteria (23 listed)
- History of any clinically significant disease or disorder which, in the opinion of the PI, may either put the volunteer at-risk because of participation in the study, or influence the results or the volunteer's ability to participate in the study.
- History or presence of gastrointestinal (GI), hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs.
- Participants with any special dietary restrictions such as subjects that are lactose intolerant or are vegetarians/vegans.
- Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of IMP.
- Any clinically significant abnormalities in clinical chemistry, hematology or urinalysis results, at screening and/or admission to the study unit as judged by the PI.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Form 1 of AZD5718 tabletsThe participants will be dosed with Form 1 of AZD5718 following an overnight fast of at least 10 hours. | Drug | Treatment A |
| Form 2 of AZD5718 tabletsThe participants will be dosed with Form 2 of AZD5718 following an overnight fast of at least 10 hours. | Drug | Treatment B |
| Form 3 of AZD5718 tabletsThe participants will be dosed with Form 3 of AZD5718 following an overnight fast of at least 10 hours. | Drug | Treatment C |
| Form 4 of AZD5718 tabletsThe participants will be dosed with Form 4 of AZD5718 following an overnight fast of at least 10 hours. | Drug | Treatment D |
| Form 5 of AZD5718 tabletsThe participants will be dosed with Form 5 of AZD5718 following an overnight fast of at least 10 hours. | Drug | Treatment E |
| Selected form (Form 2 - 5) of AZD5718 tabletsThe participant will be administered with selected form (one of Form 2-5) of AZD5718 tablets 30 minutes after start of the meal. | Drug | Treatment F |
Primary outcome
Area under plasma concentration-time curve (AUC) of AZD5718
Time frame: At pre dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36 and 48 hours post dose.
To assess the pharmacokinetics (PK) parameter AUC to evaluate the relative bioavailability of different formulations of AZD5718 and compare with the formulation (Form 1 of AZD5718 tablets) used in the Phase 2a clinical study.
AUC from time zero to time of last quantifiable concentration (AUC[0-t]) of AZD5718
Time frame: At pre dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36 and 48 hours post dose.
To assess the PK parameter AUC(0-t)to evaluate the relative bioavailability of different formulations of AZD5718 and compare with the formulation (Form 1 of AZD5718 tablets) used in the Phase 2a clinical study.
Observed maximum plasma concentration (Cmax) of AZD5718
Time frame: At pre dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36 and 48 hours post dose.
To assess the PK parameter Cmax to evaluate the relative bioavailability of different formulations of AZD5718 and compare with the formulation (Form 1 of AZD5718 tablets) used in the Phase 2a clinical study.
Observed plasma concentration at 24 hours post dose (C24) of AZD5718
Time frame: 24 hour post dose
To assess the PK parameter C24 to evaluate the relative bioavailability of different formulations of AZD5718 and compare with the formulation (Form 1 of AZD5718 tablets) used in the Phase 2a clinical study.
49 secondary outcomes
Cmax of AZD5718 in fed and fasted conditions
Time frame: At pre dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36 and 48 hours post dose.
C24 of AZD5718 in fed and fasted conditions
Time frame: At pre dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36 and 48 hours post dose.
AUC(0-t) of AZD5718 in fed and fasted conditions
Time frame: At pre dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36 and 48 hours post dose.
AUC of AZD5718 in fed and fasted conditions
Time frame: At pre dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36 and 48 hours post dose.
Number of participants with adverse events
Time frame: From randomization throughout the treatment period (Day 1 to 3) and follow-up Visit (Day 5 to 7) assessed maximum upto 6 weeks.
Assessment of systolic blood pressure
Time frame: [Part 1 - At screening (From Day -28 to Day-2); Treatment period 1 (Day-1), Treatment period 1 to 5 (Day 1 to 3)] and [Part 2- At Day-1, Day 1 to 3, 5 to 7 days post final dose].
Assessment of diastolic blood pressure
Time frame: [Part 1 - At screening (From Day -28 to Day-2); Treatment period 1 (Day-1), Treatment period 1 to 5 (Day 1 to 3)] and [Part 2- At Day-1, Day 1 to 3, 5 to 7 days post final dose].
Assessment of pulse rate
Time frame: [Part 1 - At screening (From Day -28 to Day-2); Treatment period 1 (Day-1), Treatment period 1 to 5 (Day 1 to 3)] and [Part 2- At Day-1, Day 1 to 3, 5 to 7 days post final dose].
Assessment of 12-lead electrocardiogram (ECG)
Time frame: At screening (From Day -28 to Day -2 - Part 1); 5 to 7 days post final dose (Part 2).
Assessment of physical examination
Time frame: [Part 1 - At screening (From Day -28 to Day-2); Treatment period 1 (Day-1), Treatment period 1 to 5 (Day 1 to 3)] and [Part 2- At Day-1, Day 1 to 3, 5 to 7 days post final dose].
Half-life associated with terminal slope (λz) of a semi-logarithmic concentration-time curve (t½λz) of AZD5718
Time frame: At pre dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36 and 48 hours post dose.
Time to reach maximum observed plasma concentration (Tmax) of AZD5718
Time frame: At pre dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36 and 48 hours post dose.
Apparent total body clearance of drug from plasma after extravascular administration (CL/F) of AZD5718
Time frame: At pre dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36 and 48 hours post dose.
Safety and tolerability of AZD5718 by assessment of clinical Laboratory evaluations (Hematology)- white blood cell (WBC) count
Time frame: [Part 1 - At screening (From Day -28 to Day-2); Treatment period 1 (Day-1), Treatment period 1 to 5 (Day 1 to 3)] and [Part 2- At Day-1, Day 1 to 3, 5 to 7 days post final dose]
Safety and tolerability of AZD5718 by assessment of clinical Laboratory evaluations (hematology)- red blood cell (RBC) count
Time frame: [Part 1 - At screening (From Day -28 to Day-2); Treatment period 1 (Day-1), Treatment period 1 to 5 (Day 1 to 3)] and [Part 2- At Day-1, Day 1 to 3, 5 to 7 days post final dose]
Safety and tolerability of AZD5718 by assessment of clinical Laboratory evaluations (hematology)- haemoglobin (HB)
Time frame: [Part 1 - At screening (From Day -28 to Day-2); Treatment period 1 (Day-1), Treatment period 1 to 5 (Day 1 to 3)] and [Part 2- At Day-1, Day 1 to 3, 5 to 7 days post final dose]
Safety and tolerability of AZD5718 by assessment of clinical Laboratory evaluations (hematology)- hematocrit (HCT)
Time frame: [Part 1 - At screening (From Day -28 to Day-2); Treatment period 1 (Day-1), Treatment period 1 to 5 (Day 1 to 3)] and [Part 2- At Day-1, Day 1 to 3, 5 to 7 days post final dose]
Safety and tolerability of AZD5718 by assessment of clinical Laboratory evaluations (hematology)- platelets
Time frame: [Part 1 - At screening (From Day -28 to Day-2); Treatment period 1 (Day-1), Treatment period 1 to 5 (Day 1 to 3)] and [Part 2- At Day-1, Day 1 to 3, 5 to 7 days post final dose]
Safety and tolerability of AZD5718 by assessment of clinical Laboratory evaluations (hematology)- reticulocytes absolute count
Time frame: [Part 1 - At screening (From Day -28 to Day-2); Treatment period 1 (Day-1), Treatment period 1 to 5 (Day 1 to 3)] and [Part 2- At Day-1, Day 1 to 3, 5 to 7 days post final dose]
Safety and tolerability of AZD5718 by assessment of clinical Laboratory evaluations (hematology)- mean corpuscular hemoglobin (MCH)
Time frame: [Part 1 - At screening (From Day -28 to Day-2); Treatment period 1 (Day-1), Treatment period 1 to 5 (Day 1 to 3)] and [Part 2- At Day-1, Day 1 to 3, 5 to 7 days post final dose]
Safety and tolerability of AZD5718 by assessment of clinical Laboratory evaluations (hematology)- mean corpuscular hemoglobin concentration (MCHC)
Time frame: [Part 1 - At screening (From Day -28 to Day-2); Treatment period 1 (Day-1), Treatment period 1 to 5 (Day 1 to 3)] and [Part 2- At Day-1, Day 1 to 3, 5 to 7 days post final dose]
Safety and tolerability of AZD5718 by assessment of clinical laboratory evaluations (clinical chemistry)- creatinine
Time frame: [Part 1 - At screening (From Day -28 to Day-2); Treatment period 1 (Day-1), Treatment period 1 to 5 (Day 1 to 3)] and [Part 2- At Day-1, Day 1 to 3, 5 to 7 days post final dose]
Safety and tolerability of AZD5718 by assessment of clinical laboratory evaluations (clinical chemistry)- creatine kinase
Time frame: [Part 1 - At screening (From Day -28 to Day-2); Treatment period 1 (Day-1), Treatment period 1 to 5 (Day 1 to 3)] and [Part 2- At Day-1, Day 1 to 3, 5 to 7 days post final dose]
Safety and tolerability of AZD5718 by assessment of clinical laboratory evaluations (clinical chemistry)- total bilirubin
Time frame: [Part 1 - At screening (From Day -28 to Day-2); Treatment period 1 (Day-1), Treatment period 1 to 5 (Day 1 to 3)] and [Part 2- At Day-1, Day 1 to 3, 5 to 7 days post final dose]
Safety and tolerability of AZD5718 by assessment of clinical laboratory evaluations (clinical chemistry)- unconjugated bilirubin
Time frame: [Part 1 - At screening (From Day -28 to Day-2); Treatment period 1 (Day-1), Treatment period 1 to 5 (Day 1 to 3)] and [Part 2- At Day-1, Day 1 to 3, 5 to 7 days post final dose]
Safety and tolerability of AZD5718 by assessment of clinical laboratory evaluations (clinical chemistry)- alkaline phosphatase
Time frame: [Part 1 - At screening (From Day -28 to Day-2); Treatment period 1 (Day-1), Treatment period 1 to 5 (Day 1 to 3)] and [Part 2- At Day-1, Day 1 to 3, 5 to 7 days post final dose]
Safety and tolerability of AZD5718 by assessment of clinical laboratory evaluations (clinical chemistry)- aspartate aminotransferase (AST)
Time frame: [Part 1 - At screening (From Day -28 to Day-2); Treatment period 1 (Day-1), Treatment period 1 to 5 (Day 1 to 3)] and [Part 2- At Day-1, Day 1 to 3, 5 to 7 days post final dose]
Safety and tolerability of AZD5718 by assessment of clinical laboratory evaluations (clinical chemistry)- gamma glutamyl transpeptidase (GGT)
Time frame: [Part 1 - At screening (From Day -28 to Day-2); Treatment period 1 (Day-1), Treatment period 1 to 5 (Day 1 to 3)] and [Part 2- At Day-1, Day 1 to 3, 5 to 7 days post final dose]
Safety and tolerability of AZD5718 by assessment of clinical laboratory evaluations (clinical chemistry)- albumin
Time frame: [Part 1 - At screening (From Day -28 to Day-2); Treatment period 1 (Day-1), Treatment period 1 to 5 (Day 1 to 3)] and [Part 2- At Day-1, Day 1 to 3, 5 to 7 days post final dose]
Safety and tolerability of AZD5718 by assessment of clinical laboratory evaluations (clinical chemistry)- potassium
Time frame: [Part 1 - At screening (From Day -28 to Day-2); Treatment period 1 (Day-1), Treatment period 1 to 5 (Day 1 to 3)] and [Part 2- At Day-1, Day 1 to 3, 5 to 7 days post final dose]
Safety and tolerability of AZD5718 by assessment of clinical laboratory evaluations (clinical chemistry)- sodium
Time frame: [Part 1 - At screening (From Day -28 to Day-2); Treatment period 1 (Day-1), Treatment period 1 to 5 (Day 1 to 3)] and [Part 2- At Day-1, Day 1 to 3, 5 to 7 days post final dose]
Safety and tolerability of AZD5718 by assessment of clinical Laboratory evaluations (clinical chemistry)- calcium
Time frame: [Part 1 - At screening (From Day -28 to Day-2); Treatment period 1 (Day-1), Treatment period 1 to 5 (Day 1 to 3)] and [Part 2- At Day-1, Day 1 to 3, 5 to 7 days post final dose]
Safety and tolerability of AZD5718 by assessment of clinical laboratory evaluations (clinical chemistry)- C-reactive protein
Time frame: [Part 1 - At screening (From Day -28 to Day-2); Treatment period 1 (Day-1), Treatment period 1 to 5 (Day 1 to 3)] and [Part 2- At Day-1, Day 1 to 3, 5 to 7 days post final dose]
Safety and tolerability of AZD5718 by assessment of clinical Laboratory evaluations (clinical chemistry)- urea
Time frame: [Part 1 - At screening (From Day -28 to Day-2); Treatment period 1 (Day-1), Treatment period 1 to 5 (Day 1 to 3)] and [Part 2- At Day-1, Day 1 to 3, 5 to 7 days post final dose]
Safety and tolerability of AZD5718 by assessment of clinical laboratory evaluations (clinical chemistry)- phosphate
Time frame: [Part 1 - At screening (From Day -28 to Day-2); Treatment period 1 (Day-1), Treatment period 1 to 5 (Day 1 to 3)] and [Part 2- At Day-1, Day 1 to 3, 5 to 7 days post final dose]
Safety and tolerability of AZD5718 by assessment of clinical laboratory evaluations (clinical chemistry)- glucose (fasting)
Time frame: [Part 1 - At screening (From Day -28 to Day-2); Treatment period 1 (Day-1), Treatment period 1 to 5 (Day 1 to 3)] and [Part 2- At Day-1, Day 1 to 3, 5 to 7 days post final dose]
Safety and tolerability of AZD5718 by assessment of clinical laboratory evaluations- urinalysis (blood)
Time frame: [Part 1 - At screening (From Day -28 to Day-2); Treatment period 1 (Day-1), Treatment period 1 to 5 (Day 1 to 3)] and [Part 2- At Day-1, Day 1 to 3, 5 to 7 days post final dose]
Safety and tolerability of AZD5718 by assessment of clinical laboratory evaluations- urinalysis (glucose)
Time frame: [Part 1 - At screening (From Day -28 to Day-2); Treatment period 1 (Day-1), Treatment period 1 to 5 (Day 1 to 3)] and [Part 2- At Day-1, Day 1 to 3, 5 to 7 days post final dose]
Safety and tolerability of AZD5718 by assessment of clinical laboratory evaluations (hematology)- Mean corpuscular volume (MCV)
Time frame: [Part 1 - At screening (From Day -28 to Day-2); Treatment period 1 (Day-1), Treatment period 1 to 5 (Day 1 to 3)] and [Part 2- At Day-1, Day 1 to 3, 5 to 7 days post final dose]
Safety and tolerability of AZD5718 by assessment of clinical laboratory evaluations (clinical chemistry)- Alanine aminotransferase (ALT)
Time frame: [Part 1 - At screening (From Day -28 to Day-2); Treatment period 1 (Day-1), Treatment period 1 to 5 (Day 1 to 3)] and [Part 2- At Day-1, Day 1 to 3, 5 to 7 days post final dose]
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pablo Forte Soto, MD principal investigator
PAREXEL Early Phase Clinical Unit London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Form 1 of AZD5718 tablets, Form 2 of AZD5718 tablets and Form 3 of AZD5718 tablets in people with Coronary Artery Disease, run by AstraZeneca at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under plasma concentration-time curve (AUC) of AZD5718 (time frame: At pre dose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36 and 48 hours post dose.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2018.