Healthy Male SubjectsPhase 1NCT02632526
A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD5718 After Single and Multiple Ascending Dose Administration to Healthy Male Subjects
A Phase 1 study testing AZD5718 oral suspension crystalline form (1 to 100 mg/mL) (Part A), AZD5718 oral suspension amorphous (1 to 100 mg/mL) (Part A) and AZD5718 oral suspension amorphous (1 to 100 mg/mL) (Part B) in people with Healthy Male Subjects and Cardiovascular Disease, run by AstraZeneca at 1 site in United Kingdom.
Trial summary
This is a phase I, randomised, single-blind, placebo-controlled, first-in-human (FIH) single and multiple ascending dose study consisting of two parts (Part A [SAD] and Part B [MAD]) to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of AZD5718 in healthy male subjects Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Male Subjects, Cardiovascular Disease
- What is being tested?
- AZD5718 oral suspension crystalline form (1 to 100 mg/mL) (Part A), AZD5718 oral suspension amorphous (1 to 100 mg/mL) (Part A) and AZD5718 oral suspension amorphous (1 to 100 mg/mL) (Part B)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 10 Feb 2016to 26 Aug 2016
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Provision of signed and dated, written informed consent prior to any study specific procedures
- Healthy male subjects aged 18 - 50 years, inclusive, with suitable veins for cannulation or repeated venepuncture
- 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 research
Who cannot join
- History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject'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
- Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the administration of investigational medicinal product (IMP)
- Any clinically significant abnormalities in clinical chemistry, haematology, or urinalysis results at screening and check-in, as judged by the investigator, including:
- Alanine aminotransferase (ALT) > upper limit of normal (ULN);
- Aspartate aminotransferase (AST) > ULN;
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- Bilirubin (total) > ULN; and
- Gamma glutamyl transpeptidase (GGT) > ULN
- Any positive result on screening for serum hepatitis B surface antigen (HBsAg), hepatitis C antibody and human immunodeficiency virus (HIV)
- Suspicion or known Gilbert's syndrome
- Abnormal vital signs, after 10 minutes supine rest, at screening and check-in, defined as any of the following:
- Systolic blood pressure(BP) (SBP) < 90mmHg or ≥ 140 mmHg;
- Diastolic BP (DBP) < 50mmHg or ≥ 90 mmHg; and
- Pulse < 45 or > 85 beats per minute (bpm)
- Any clinically significant abnormalities (at screening and check-in) in rhythm, conduction or morphology of the resting ECG and any clinically significant abnormalities in the 12-lead ECG, as considered by the investigator that may interfere with the interpretation of QTc interval changes, including abnormal ST-T-wave morphology, particularly in the protocol defined primary lead or left ventricular hypertrophy
- Prolonged QTcF (QT interval corrected for heart rate using Fridericia's formula) > 450 ms or shortened QTcF < 340 ms or family history of long QT syndrome, at screening and check-in
- PR(PQ) interval (ECG interval measured from the onset of the P wave to the onset of the QRS complex) shortening < 120 ms (PR > 110 ms but < 120 ms is acceptable if there is no evidence of ventricular pre-excitation), at screening and check-in
- PR (PQ) interval prolongation (> 240 ms) intermittent second (Wenckebach block while asleep is not exclusive) or third degree AV block, or AV dissociation, at screening and check-in
- Persistent or intermittent complete bundle branch block (BBB), incomplete bundle branch block (IBBB), or intraventricular conduction delay (IVCD) with QRS > 110 ms. Subjects with QRS > 110 ms but < 115 ms are acceptable if there is no evidence of, for example, ventricular hypertrophy or pre-excitation, at screening and check-in
- Known or suspected history of drug abuse, as judged by the investigator
- Current smokers or those who have smoked or used nicotine products within the 3 months prior to screening
- Any history of alcohol abuse or excessive intake of alcohol, as judged by the investigator
- Positive screen for drugs of abuse, alcohol or cotinine (nicotine) at screening or admission to the unit
- History of severe allergy/hypersensitivity or ongoing clinically significant allergy/hypersensitivity, as judged by the investigator or history of hypersensitivity to drugs with a similar chemical structure or class to AZD5718
- Excessive intake of caffeine containing drinks or food (e.g., coffee, tea, chocolate), as judged by the investigator
- Use of drugs with enzyme inducing properties such as St John's Wort within 3 weeks prior to 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 prior to the administration of IMP or longer if the medication has a long half-life
- Plasma donation within 1 month of screening or any blood donation/blood loss > 500 mL during the 3 months prior to screening
- Has received another new chemical entity (defined as a compound which has not been approved for marketing) within 3 months of the administration of IMP in this study. The period of exclusion is 3 months after the final dose from a previous study
- Vulnerable subjects, e.g., kept in detention, protected adults under guardianship, trusteeship, or committed to an institution by governmental or juridical order
- Involvement of any AstraZeneca, PAREXEL or study site employee or their close relatives
- Judgment by the investigator that the subject should not participate in the study if they have any ongoing or recent (i.e., during the screening period) minor medical complaints that may interfere with the interpretation of study data or are considered unlikely to comply with study procedures, restrictions and requirements
- Subjects who are vegans or have medical dietary restrictions
- Subjects who cannot communicate reliably with the investigator
- In addition, any of the following is regarded as a criterion for exclusion from the genetic research:
- Previous bone marrow transplant
- Non-leukocyte depleted whole blood transfusion within 120 days of the date of the genetic sample collection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Randomized, Single-blind, Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD5718 After Single and Multiple Ascending Dose Administration to Healthy Male Subjects
This is a phase I, randomised, single-blind, placebo-controlled, first-in-human (FIH) single and multiple ascending dose study consisting of two parts (Part A [SAD] and Part B [MAD]) to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of AZD5718 in healthy male subjects
Read the detailed description
This is a phase I, randomised, single-blind, placebo-controlled, first-in-human (FIH) single and multiple ascending dose study consisting of two parts (Part A [SAD] and Part B [MAD]) to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of AZD5718 in healthy male subjects
- Conditions
- Healthy Male Subjects, Cardiovascular Disease
- Being tested
- AZD5718 oral suspension crystalline form (1 to 100 mg/mL) (Part A), AZD5718 oral suspension amorphous (1 to 100 mg/mL) (Part A), AZD5718 placebo oral suspension, AZD5718 oral suspension amorphous (1 to 100 mg/mL) (Part B)
- Keywords
- AZD5718 oral suspension crystalline, AZD5718 oral suspension amorphous, Single ascending dose/multiple ascending dose (SAD/MAD), Placebo-controlled, Safety, Tolerability, Pharmacokinetics, Pharmacodynamics
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD5718 oral suspension crystalline form (1 to 100 mg/mL) (Part A)Drug
Oral suspension single dose
AZD5718 oral suspension amorphous (1 to 100 mg/mL) (Part A)Drug
Single and multiple doses
AZD5718 placebo oral suspensionDrug
Single and multiple doses
AZD5718 oral suspension amorphous (1 to 100 mg/mL) (Part B)Drug
Single and multiple doses
| Study group | Role | What they receive |
|---|---|---|
| AZD5718 amorphous form, treatment 1 (Part A) | Experimental | Starting dose 25 mg/day, single ascending dose Receives: Drug: AZD5718 oral suspension amorphous (1 to 100 mg/mL) (Part A); Drug: AZD5718 placebo oral suspension |
| AZD5718 amorphous form, treatment 2 (Part A) | Experimental | Single dose of AZD5718 amorphous suspension Receives: Drug: AZD5718 oral suspension amorphous (1 to 100 mg/mL) (Part A); Drug: AZD5718 placebo oral suspension |
| AZD5718 amorphous form, treatment 3 (Part A) | Experimental | Single dose of AZD5718 amorphous suspension Receives: Drug: AZD5718 oral suspension amorphous (1 to 100 mg/mL) (Part A); Drug: AZD5718 placebo oral suspension |
| AZD5718 amorphous form, treatment 4 (Part A) | Experimental | Single dose of AZD5718 amorphous suspension Receives: Drug: AZD5718 oral suspension amorphous (1 to 100 mg/mL) (Part A); Drug: AZD5718 placebo oral suspension |
| AZD5718 amorphous form, treatment 5 (Part A) | Experimental | Single dose of AZD5718 amorphous suspension Receives: Drug: AZD5718 oral suspension amorphous (1 to 100 mg/mL) (Part A); Drug: AZD5718 placebo oral suspension |
| AZD5718 amorphous form, treatment 6 (Part A) | Experimental | Single dose of AZD5718 amorphous suspension Receives: Drug: AZD5718 oral suspension amorphous (1 to 100 mg/mL) (Part A); Drug: AZD5718 placebo oral suspension |
| AZD5718, crystalline form, treatment 7 (Part A) | Experimental | Crystalline suspension (Part A), dosage lower than highest dose used with amorphous suspension, single ascending dose Receives: Drug: AZD5718 oral suspension crystalline form (1 to 100 mg/mL) (Part A); Drug: AZD5718 placebo oral suspension |
| AZD5718 crystalline form, treatment 8 (Part A) | Experimental | Crystalline suspension (Part A), dosage lower than highest dose used with amorphous suspension, single ascending dose Receives: Drug: AZD5718 oral suspension crystalline form (1 to 100 mg/mL) (Part A); Drug: AZD5718 placebo oral suspension |
| AZD5718 amorphous form, treatment 1 (Part B) | Experimental | Once or twice daily from Days 2 to 9 and single doses on Days 1 and 10, dosage TBD (Part A) Receives: Drug: AZD5718 placebo oral suspension; Drug: AZD5718 oral suspension amorphous (1 to 100 mg/mL) (Part B) |
| AZD5718 amorphous form, treatment 2 (Part B) | Experimental | Once or twice daily from Days 2 to 9 and single doses on Days 1 and 10, dosage TBD (Part A) Receives: Drug: AZD5718 placebo oral suspension; Drug: AZD5718 oral suspension amorphous (1 to 100 mg/mL) (Part B) |
| AZD5718 amorphous form, treatment 3 (Part B) | Experimental | Once or twice daily from Days 2 to 9 and single doses on Days 1 and 10, dosage TBD (Part A) Receives: Drug: AZD5718 placebo oral suspension; Drug: AZD5718 oral suspension amorphous (1 to 100 mg/mL) (Part B) |
| AZD5718 amorphous form, treatment 4 (Part B) | Experimental | Once or twice daily from Days 2 to 9 and single doses on Days 1 and 10, dosage TBD (Part A) Receives: Drug: AZD5718 placebo oral suspension; Drug: AZD5718 oral suspension amorphous (1 to 100 mg/mL) (Part B) |
| AZD5718 amorphous/crystalline form, repeat 1 (Part A) | Experimental | Single dose of AZD5718 amorphous form (Part A) Crystalline form (Part A), dosage lower than highest dose used with amorphous form, single ascending dose Receives: Drug: AZD5718 oral suspension crystalline form (1 to 100 mg/mL) (Part A); Drug: AZD5718 oral suspension amorphous (1 to 100 mg/mL) (Part A); Drug: AZD5718 placebo oral suspension |
| AZD5718 amorphous/crystalline form, repeat 2 (Part A) | Experimental | Single dose of AZD5718 amorphous form (Part A) Crystalline form (Part A), dosage lower than highest dose used with amorphous form, single ascending dose Receives: Drug: AZD5718 oral suspension crystalline form (1 to 100 mg/mL) (Part A); Drug: AZD5718 oral suspension amorphous (1 to 100 mg/mL) (Part A); Drug: AZD5718 placebo oral suspension |
| AZD5718 amorphous/crystalline, repeat 3 (Part A) | Experimental | Single dose of AZD5718 amorphous form (Part A) Crystalline form (Part A), dosage lower than highest dose used with amorphous form, single ascending dose Receives: Drug: AZD5718 oral suspension crystalline form (1 to 100 mg/mL) (Part A); Drug: AZD5718 oral suspension amorphous (1 to 100 mg/mL) (Part A) |
| AZD5718 amorphous form, repeat 1 (Part B) | Experimental | Twice daily dosing (Day 1 - 9) and once daily dosing (Day 10), dosage TBD (Part A) Receives: Drug: AZD5718 placebo oral suspension; Drug: AZD5718 oral suspension amorphous (1 to 100 mg/mL) (Part B) |
| AZD5718 amorphous form, repeat 2 (Part B) | Experimental | Twice daily dosing (Day 1 - 9) and once daily dosing (Day 10), dosage TBD (Part A) Receives: Drug: AZD5718 placebo oral suspension; Drug: AZD5718 oral suspension amorphous (1 to 100 mg/mL) (Part B) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability of AZD5718 by Assessment of the Number of Participants With Adverse Events Following Oral Administration of SAD (Part A) and MAD (Part B).
To assess the safety and tolerability of AZD5718 following oral administration of SAD (Part A) and MAD (Part B).
Measured: From screening to last followup visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B)
Secondary outcomes (29)
Rate and Extent of Absorption of AZD5718 by Assessment of the Area Under the Plasma Concentration-curve From Time Zero Extrapolated to Infinity (AUC) for Part A - Amorphous and Crystalline Suspension
To assess area under the concentration-time curve from time zero extrapolated to infinity and was estimated by AUC(0-last) + Clast/λz (Clast - the last observed quantifiable concentration) following a single administration of AZD5718 Amorphous and Crystalline suspension (Part A only)
Measured: At post-dose (Days 1 to 3); 0.5, 1, 2, 3, 4, 6, 8, 24, 36 and 48 hours post-dose and folow up (Day 4 - 72 hours post-dose) (Part A only)
Rate and Extent of Absorption of AZD5718 by Assessment of the Area Under Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC) for Part B - Amorphous Suspension
To assess the rate and extent of absorption of AZD5718 by evaluation of the area under plasma concentration-time curve from time zero extrapolated to infinity (AUC) following a single AZD5718 dose on Day 1 and multiple daily dosing on Days 9 or 10 under fasted conditions (Part B)
Measured: Day 1 of Part B
Rate and Extent of Absorption of AZD5718 by Assessment of the Area Under the Plasma Concentration-curve From Time Zero to Time of Last Quantifiable Concentration (AUC(0-last)) for Part A - Amorphous and Crystalline Suspension
To assess area under the area under the plasma concentration-curve from time zero to the time of last quantifiable concentration (AUC(0-last)) following a single administration of AZD5718 Amorphous and Crystalline suspension (Part A only)
Measured: At post-dose (Days 1 to 3); 0.5, 1, 2, 3, 4, 6, 8, 24, 36 and 48 hours post-dose and folow up (Day 4 - 72 hours post-dose) (Part A only)
Rate and Extent of Absorption of AZD5718 by Assessment of the Area Under the Plasma Concentration-curve Over the Dosing Interval (AUC(0-τ)) for Part B - Amorphous Suspension
To assess the rate and extent of absorption of AZD5718 by evaluation of the area under the plasma concentration-curve over the dosing interval (AUC(0-τ)) following a single AZD5718 dose on Day 1 and multiple daily dosing on Days 9 or 10 under fasted conditions (Part B)
Measured: Day 1, Day 9 and Day 10 of Part B
Rate and Extent of Absorption of AZD5718 by Assessment of the Observed Maximum Plasma Concentration (Cmax) for Part A - Amorphous and Crystalline Suspension
To assess observed maximum plasma concentration (Cmax) following a single administration of AZD5718 Amorphous and Crystalline suspension (Part A only)
Measured: At post-dose (Days 1 to 3); 0.5, 1, 2, 3, 4, 6, 8, 24, 36 and 48 hours post-dose and folow up (Day 4 - 72 hours post-dose) (Part A only)
Rate and Extent of Absorption of AZD5718 by Assessment of the Observed Maximum Plasma Concentration (Cmax) for Part B - Amorphous Suspension
To assess the rate and extent of absorption of AZD5718 by evaluation of the observed maximum plasma concentration (Cmax) following a single AZD5718 dose on Day 1 and multiple daily dosing on Days 9 or 10 under fasted conditions (Part B)
Measured: Day 1, Day 9 and Day 10 (Part B only)
Rate and Extent of Absorption of AZD5718 by Assessment of the Time to Reach the Observed Maximum Plasma Concentration (Tmax) for Part A - Amorphous and Crystalline Suspension
To assess the time to reach the observed maximum plasma concentration (tmax) following a single administration of AZD5718 Amorphous and Crystalline suspension (Part A only)
Measured: At post-dose (Days 1 to 3); 0.5, 1, 2, 3, 4, 6, 8, 24, 36 and 48 hours post-dose and folow up (Day 4 - 72 hours post-dose) (Part A only)
Rate and Extent of Absorption of AZD5718 by Assessment of the Time to Reach the Observed Maximum Plasma Concentration (Tmax) for Part B - Amorphous Suspension
To assess the rate and extent of absorption of AZD5718 by evaluation of the time to reach the observed maximum plasma concentration (tmax) following a single AZD5718 dose on Day 1 and multiple daily dosing on Days 9 or 10 under fasted conditions (Part B)
Measured: Day 1, Day 9 and Day 10 (Part B only)
Rate and Extent of Absorption of AZD5718 by Assessment of the Half-life Associated With Terminal Slope of a Semi-logarithmic Plasma Concentration-time Curve (t½λz) for Part A - Amorphous and Crystalline Suspension
To assess Rate and extent of absorption of AZD5718 by assessment of the half-life associated with terminal slope of a semi-logarithmic plasma concentration-time curve (t½λz) following a single administration of AZD5718 Amorphous and Crystalline suspension (Part A only)
Measured: At post-dose (Days 1 to 3); 0.5, 1, 2, 3, 4, 6, 8, 24, 36 and 48 hours post-dose and folow up (Day 4 - 72 hours post-dose) (Part A only)
Rate and Extent of Absorption of AZD5718 by Assessment of the Half-life Associated With Terminal Slope of a Semi-logarithmic Plasma Concentration-time Curve (t½λz) for Part B - Amorphous Suspension
To assess the rate and extent of absorption of AZD5718 by evaluation of the half-life associated with terminal slope of a semi-logarithmic plasma concentration-time curve (t½λz) following a single AZD5718 dose on Day 1 and multiple daily dosing on Days 9 or 10 under fasted conditions (Part B)
Measured: Day 1 and Day 10 (Part B only)
Rate and Extent of Absorption of AZD5718 by Assessment of the Apparent Total Body Clearance After Extravascular Administration Estimated as Dose Divided by AUC (CL/F) for Part A - Amorphous and Crystalline Suspension
To assess rate and extent of absorption of AZD5718 by assessment of the apparent total body clearance after extravascular administration estimated as dose divided by AUC (CL/F) following a single administration of AZD5718 Amorphous and Crystalline suspension (Part A only)
Measured: At post-dose (Days 1 to 3); 0.5, 1, 2, 3, 4, 6, 8, 24, 36 and 48 hours post-dose and folow up (Day 4 - 72 hours post-dose) (Part A only)
Rate and Extent of Absorption of AZD5718 by Assessment of the Apparent Total Body Clearance After Extravascular Administration Estimated as Dose Divided by AUC (CL/F) for Part B - Amorphous Suspension
To assess rate and extent of absorption of AZD5718 by assessment of the Rate and extent of absorption of AZD5718 by assessment of CL/F estimated as dose divided by AUC (for Day 1 only) and dose divided by AUCτ on Day 10 following a single AZD5718 dose on Day 1 and multiple daily dosing on Days 9 or 10 under fasted conditions (Part B)
Measured: Day 1 and Day 10 of Part B
Rate and Extent of Absorption of AZD5718 by Assessment of the Apparent Volume of Distribution During the Terminal Phase After Extravascular Administration (Vz/F) for Part A - Amorphous and Crystalline Suspension
To assess rate and extent of absorption of AZD5718 by assessment of the apparent volume of distribution during the terminal phase after extravascular administration (Vz/F) following a single administration of AZD5718 Amorphous and Crystalline suspension (Part A only)
Measured: At post-dose (Days 1 to 3); 0.5, 1, 2, 3, 4, 6, 8, 24, 36 and 48 hours post-dose and folow up (Day 4 - 72 hours post-dose)
To Evaluate the Relative Bioavailability Between the Amorphous and Crystalline Form of AZD5718 (Part A) by Assessment of AUC for Part A - Amorphous and Crystalline Suspension
To assess the relative bioavailability by AUC between the cohort receiving the crystalline suspension and the corresponding data from the cohort receiving the same dose of the amorphous suspension (Part A only). Crystalline suspension was compared to the reference amorphous suspension.
Note: Geometric mean ratios for crystalline/amorphous suspensions were calculated
Measured: At post-dose (Days 1 to 3); 0.5, 1, 2, 3, 4, 6, 8,12, 24, 36, and 48 hours post-dose and folow up (Day 4 - 72 hours post-dose)
To Evaluate the Relative Bioavailability Between the Amorphous and Crystalline Form of AZD5718 (Part A) by Assessment of Cmax for Part A - Amorphous and Crystalline Suspension
To assess the relative bioavailability by Cmax between the cohort receiving the crystalline suspension and the corresponding data from the cohort receiving the same dose of the amorphous suspension (Part A only). Crystalline suspension was compared to the reference amorphous suspension.
Note: Geometric mean ratios for crystalline/amorphous suspensions were calculated
Measured: At post-dose (Days 1 to 3); 0.5, 1, 2, 3, 4, 6, 8, 24, 36 and 48 hours post-dose and folow up (Day 4 - 72 hours post-dose) (Part A only)
Rate and Extent of Absorption of AZD5718 by Assessment of the Accumulation Ratio for AUC(0-τ) (RAC AUC(0-τ)) for Part B - Amorphous Suspension
To assess rate and extent of absorption of AZD5718 by assessment of the Rate and extent of absorption of AZD5718 by assessment of accumulation ratio for AUC(0-τ) (RAC AUC(0-τ)) following a single AZD5718 dose on Day 1 and multiple daily dosing on Days 9 or 10 under fasted conditions (Part B) Accumulation ratio calculated as AUC0-τ Day 10/AUC0-τ Day 1 (first dose) for Part B under fasted condition and presented values for Day 10
Measured: Day 1 and Day 9 (Part B only)
Rate and Extent of Absorption of AZD5718 by Assessment of the Accumulation Ratio for Cmax (RAC Cmax) for Part B (Amorphous Suspension) Under Fasted Condition
To assess the rate and extent of absorption of AZD5718 by evaluation of accumulation ratio for Cmax (RAC Cmax) following a single AZD5718 dose on Day 1 and multiple daily dosing on Days 9 or 10 under fasted conditions (Part B). Accumulation ratio calculated as Cmax Day 10/Cmax Day 1 (first dose) for Part B under fasted condition.
Measured: Day 1 and Day 9 (Part B only)
Rate and Extent of Absorption of AZD5718 by Assessment of the Temporal Change Parameter in Systemic Exposure (TCP) for Part B (Amorphous Suspension) Under Fasted Condition
To assess rate and extent of absorption of AZD5718 by assessment of the temporal change parameter in systemic exposure (TCP) following a single AZD5718 dose on Day 1 and multiple daily dosing on Days 9 or 10 under fasted conditions (Part B).
TCP calculated as AUCτDay10/AUCDay 1 and presented values for Day 10
Measured: At Day 10 (Part B only)
Rate and Extent of Absorption of AZD5718 by Assessment of the Effect of Food Following Administration of 180 mg AZD5718 With Food (Part B Day 9) and Fasted (Part B Day 10)
The effect of food was evaluated by the assessment of the PK parameter (Cmax) following multiple daily doses of 180 mg AZD5718 under fasted condition (Part B Day 10) and immediately following a high-fat breakfast (Part B Day 9)
Measured: At Day 9 and Day 10 (Part B only)
Rate and Extent of Absorption of AZD5718 by Assessment of the Effect of Food Following Administration of 180 mg AZD5718 With Food (Part B Day 9) and Fasted (Part B Day 10)
The effect of food was evaluated by the assessment of the PK parameter (AUC(0-t) following multiple daily doses of 180 mg AZD5718 under fasted condition (Part B Day 10) and immediately following a high-fat breakfast (Part B Day 9)
Measured: At Day 9 and Day 10 (Part B only)
Rate and Extent of Absorption of AZD5718 by Assessment of the Effect of Food Following Administration of 180 mg AZD5718 With Food (Part B Day 9) and Fasted (Part B Day 10)
The effect of food was evaluated by the assessment of the PK parameter(tmax) following multiple daily doses of 180 mg AZD5718 under fasted condition (Part B Day 10) and immediately following a high-fat breakfast (Part B Day 9)
Measured: At Day 9 and Day 10 (Part B only)
Rate and Extent of Absorption of AZD5718 by Assessment of Cumulative Amount of Analyte Excreted at the Last Sampling Interval (CumAe0-24) Following a Single Administration of AZD5718 Amorphous and Crystalline Suspension (Part A)
To assess urine PK parameter (CumAe0-24) after a single administration of AZD5718 Amorphous suspension in Part A
Measured: Part A pre-dose and pooled intervals up to 24 hours post-dose
Rate and Extent of Absorption of AZD5718 by Assessment of Percentage of Dose Excreted Unchanged Into the Urine From 0 to 24 Hours (Cumfe0-24) Following a Single Administration of AZD5718 Amorphous and Crystalline Suspension (Part A)
To assess urine PK parameter (Cumfe0-24) estimated by dividing Ae(0-last) by dose after a single administration of AZD5718 Amorphous suspension in Part A
Measured: Part A pre-dose and pooled intervals up to 24 hours post-dose
Rate and Extent of Absorption of AZD5718 by Assessment of Renal Clearance (CLR) Following a Single Administration of AZD5718 Amorphous and Crystalline Suspension (Part A)
To assess the urine PK parameter (CLR) after a single administration of AZD5718 Amorphous suspension in Part A
Measured: Part A pre-dose and pooled intervals up to 24 hours post-dose
Rate and Extent of Absorption of AZD5718 by Assessment of Cumulative Amount of Analyte Excreted From 0 to 24 Hours (CumAe0-24) Following a Multiple Daily Doses Administration of AZD5718 Amorphous Suspension (Part B Day 9)
To assess the urine PK parameter (CumAe0-24) after a single administration of AZD5718 Amorphous suspension in Part B Day 9
Measured: Part B only, Day 9 at pooled 3 hour intervals until 24 hours post-dose
Rate and Extent of Absorption of AZD5718 by Assessment of Percentage of Dose Excreted Unchanged Into the Urine From 0 to 24 Hours (Cumfe0-24) Following a Multiple Daily Doses Administration of AZD5718 Amorphous Suspension (Part B Day 9)
To assess urine PK parameter (Cumfe0-24) estimated by dividing Ae(0-last) by dose after a single administration of AZD5718 Amorphous suspension in Part B Day 9
Measured: Part B only, Day 9 at pooled 3 hour intervals until 24 hours post-dose
Rate and Extent of Absorption of AZD5718 by Assessment of Renal Clearance (CLR) Following a Multiple Daily Doses Administration of AZD5718 Amorphous Suspension (Part B Day 9)
To assess the urine PK parameter (CLR) after a single administration of AZD5718 Amorphous suspension in Part B Day 9
Measured: Part B only, Day 9 at pooled 3 hour intervals until 24 hours post-dose
Pharmacodynamic Analysis by ex Vivo Stimulation of Leukotriene B4 (LTB4) Production Using Calcium Ionophore for Part A -Amorphous and Crystalline Suspension
To assess the change from baseline in the ex vivo stimulated LTB4 production using calcium ionophore in venous blood samples following a single administration of AZD5718 Amorphous and Crystalline suspension (Part A only)
Measured: Admission to 0.5, 1, 2, 3, 4, 6, 8, 24, 36 and 48 hours post-dose (Part A only)
Pharmacodynamic Analysis by ex Vivo Stimulation of LTB4 Production Using Calcium Ionophore for Part B - Amorphous Suspension
To assess the change from baseline in the ex vivo stimulated LTB4 production using calcium ionophore in venous blood samples following multiple administration of AZD5718 Amorphous suspension (Part B only)
Measured: Admission, predose and 0.5, 1, 2, 3, 4, 6, 8, 24, 36 and 48 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2015 (estimated)
- Study start10 Feb 2016
- Primary completion26 Aug 2016
- Study completion26 Aug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Healthy Male SubjectsStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Annelize Koch, MBChB, FFPM, Principal investigator, Parexel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02632526
- Sponsor's protocol ID
- D7550C00001
- Status last verified
- Dec 2018
- First submitted
- 7 Dec 2015
- Last updated
- 21 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomized, Single-blind, Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD5718 After Single and Multiple Ascending Dose Administration to Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT02632526
- Acronym / sponsor ID
- D7550C00001
- Conditions
- Healthy Male Subjects, Cardiovascular Disease
- Keywords
- AZD5718 oral suspension crystalline, AZD5718 oral suspension amorphous, Single ascending dose/multiple ascending dose (SAD/MAD), Placebo-controlled, Safety, Tolerability, Pharmacokinetics, Pharmacodynamics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 10 Feb 2016 (actual)
- Primary completion
- 26 Aug 2016 (actual)
- Study completion
- 26 Aug 2016 (actual)
- First posted
- 16 Dec 2015 (estimated)
- Results
- Posted 21 Mar 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase I, randomised, single-blind, placebo-controlled, first-in-human (FIH) single and multiple ascending dose study consisting of two parts (Part A [SAD] and Part B [MAD]) to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of AZD5718 in healthy male subjects
Detailed description
This is a phase I, randomised, single-blind, placebo-controlled, first-in-human (FIH) single and multiple ascending dose study consisting of two parts (Part A [SAD] and Part B [MAD]) to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of AZD5718 in healthy male subjects
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 17
| Arm | Type | Receives |
|---|---|---|
| AZD5718 amorphous form, treatment 1 (Part A) | Experimental | Drug: AZD5718 oral suspension amorphous (1 to 100 mg/mL) (Part A), Drug: AZD5718 placebo oral suspensionStarting dose 25 mg/day, single ascending dose |
| AZD5718 amorphous form, treatment 2 (Part A) | Experimental | Drug: AZD5718 oral suspension amorphous (1 to 100 mg/mL) (Part A), Drug: AZD5718 placebo oral suspensionSingle dose of AZD5718 amorphous suspension |
| AZD5718 amorphous form, treatment 3 (Part A) | Experimental | Drug: AZD5718 oral suspension amorphous (1 to 100 mg/mL) (Part A), Drug: AZD5718 placebo oral suspensionSingle dose of AZD5718 amorphous suspension |
| AZD5718 amorphous form, treatment 4 (Part A) | Experimental | Drug: AZD5718 oral suspension amorphous (1 to 100 mg/mL) (Part A), Drug: AZD5718 placebo oral suspensionSingle dose of AZD5718 amorphous suspension |
| AZD5718 amorphous form, treatment 5 (Part A) | Experimental | Drug: AZD5718 oral suspension amorphous (1 to 100 mg/mL) (Part A), Drug: AZD5718 placebo oral suspensionSingle dose of AZD5718 amorphous suspension |
| AZD5718 amorphous form, treatment 6 (Part A) | Experimental | Drug: AZD5718 oral suspension amorphous (1 to 100 mg/mL) (Part A), Drug: AZD5718 placebo oral suspensionSingle dose of AZD5718 amorphous suspension |
| AZD5718, crystalline form, treatment 7 (Part A) | Experimental | Drug: AZD5718 oral suspension crystalline form (1 to 100 mg/mL) (Part A), Drug: AZD5718 placebo oral suspensionCrystalline suspension (Part A), dosage lower than highest dose used with amorphous suspension, single ascending dose |
| AZD5718 crystalline form, treatment 8 (Part A) | Experimental | Drug: AZD5718 oral suspension crystalline form (1 to 100 mg/mL) (Part A), Drug: AZD5718 placebo oral suspensionCrystalline suspension (Part A), dosage lower than highest dose used with amorphous suspension, single ascending dose |
| AZD5718 amorphous form, treatment 1 (Part B) | Experimental | Drug: AZD5718 placebo oral suspension, Drug: AZD5718 oral suspension amorphous (1 to 100 mg/mL) (Part B)Once or twice daily from Days 2 to 9 and single doses on Days 1 and 10, dosage TBD (Part A) |
| AZD5718 amorphous form, treatment 2 (Part B) | Experimental | Drug: AZD5718 placebo oral suspension, Drug: AZD5718 oral suspension amorphous (1 to 100 mg/mL) (Part B)Once or twice daily from Days 2 to 9 and single doses on Days 1 and 10, dosage TBD (Part A) |
| AZD5718 amorphous form, treatment 3 (Part B) | Experimental | Drug: AZD5718 placebo oral suspension, Drug: AZD5718 oral suspension amorphous (1 to 100 mg/mL) (Part B)Once or twice daily from Days 2 to 9 and single doses on Days 1 and 10, dosage TBD (Part A) |
| AZD5718 amorphous form, treatment 4 (Part B) | Experimental | Drug: AZD5718 placebo oral suspension, Drug: AZD5718 oral suspension amorphous (1 to 100 mg/mL) (Part B)Once or twice daily from Days 2 to 9 and single doses on Days 1 and 10, dosage TBD (Part A) |
| AZD5718 amorphous/crystalline form, repeat 1 (Part A) | Experimental | Drug: AZD5718 oral suspension crystalline form (1 to 100 mg/mL) (Part A), Drug: AZD5718 oral suspension amorphous (1 to 100 mg/mL) (Part A), Drug: AZD5718 placebo oral suspensionSingle dose of AZD5718 amorphous form (Part A) Crystalline form (Part A), dosage lower than highest dose used with amorphous form, single ascending dose |
| AZD5718 amorphous/crystalline form, repeat 2 (Part A) | Experimental | Drug: AZD5718 oral suspension crystalline form (1 to 100 mg/mL) (Part A), Drug: AZD5718 oral suspension amorphous (1 to 100 mg/mL) (Part A), Drug: AZD5718 placebo oral suspensionSingle dose of AZD5718 amorphous form (Part A) Crystalline form (Part A), dosage lower than highest dose used with amorphous form, single ascending dose |
| AZD5718 amorphous/crystalline, repeat 3 (Part A) | Experimental | Drug: AZD5718 oral suspension crystalline form (1 to 100 mg/mL) (Part A), Drug: AZD5718 oral suspension amorphous (1 to 100 mg/mL) (Part A)Single dose of AZD5718 amorphous form (Part A) Crystalline form (Part A), dosage lower than highest dose used with amorphous form, single ascending dose |
| AZD5718 amorphous form, repeat 1 (Part B) | Experimental | Drug: AZD5718 placebo oral suspension, Drug: AZD5718 oral suspension amorphous (1 to 100 mg/mL) (Part B)Twice daily dosing (Day 1 - 9) and once daily dosing (Day 10), dosage TBD (Part A) |
| AZD5718 amorphous form, repeat 2 (Part B) | Experimental | Drug: AZD5718 placebo oral suspension, Drug: AZD5718 oral suspension amorphous (1 to 100 mg/mL) (Part B)Twice daily dosing (Day 1 - 9) and once daily dosing (Day 10), dosage TBD (Part A) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Provision of signed and dated, written informed consent prior to any study specific procedures
- Healthy male subjects aged 18 - 50 years, inclusive, with suitable veins for cannulation or repeated venepuncture
- 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 research
Key exclusion criteria (37 listed)
- History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject'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
- Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the administration of investigational medicinal product (IMP)
- Any clinically significant abnormalities in clinical chemistry, haematology, or urinalysis results at screening and check-in, as judged by the investigator, including:
- Any positive result on screening for serum hepatitis B surface antigen (HBsAg), hepatitis C antibody and human immunodeficiency virus (HIV)
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 |
|---|---|---|
| AZD5718 oral suspension crystalline form (1 to 100 mg/mL) (Part A)Oral suspension single dose | Drug | AZD5718 amorphous/crystalline form, repeat 1 (Part A), AZD5718 amorphous/crystalline form, repeat 2 (Part A), AZD5718 amorphous/crystalline, repeat 3 (Part A), AZD5718 crystalline form, treatment 8 (Part A), AZD5718, crystalline form, treatment 7 (Part A) |
| AZD5718 oral suspension amorphous (1 to 100 mg/mL) (Part A)Single and multiple doses | Drug | AZD5718 amorphous form, treatment 1 (Part A), AZD5718 amorphous form, treatment 2 (Part A), AZD5718 amorphous form, treatment 3 (Part A), AZD5718 amorphous form, treatment 4 (Part A), AZD5718 amorphous form, treatment 5 (Part A), AZD5718 amorphous form, treatment 6 (Part A), AZD5718 amorphous/crystalline form, repeat 1 (Part A), AZD5718 amorphous/crystalline form, repeat 2 (Part A), AZD5718 amorphous/crystalline, repeat 3 (Part A) |
| AZD5718 placebo oral suspensionSingle and multiple doses | Drug | AZD5718 amorphous form, repeat 1 (Part B), AZD5718 amorphous form, repeat 2 (Part B), AZD5718 amorphous form, treatment 1 (Part A), AZD5718 amorphous form, treatment 1 (Part B), AZD5718 amorphous form, treatment 2 (Part A), AZD5718 amorphous form, treatment 2 (Part B), AZD5718 amorphous form, treatment 3 (Part A), AZD5718 amorphous form, treatment 3 (Part B), AZD5718 amorphous form, treatment 4 (Part A), AZD5718 amorphous form, treatment 4 (Part B), AZD5718 amorphous form, treatment 5 (Part A), AZD5718 amorphous form, treatment 6 (Part A), AZD5718 amorphous/crystalline form, repeat 1 (Part A), AZD5718 amorphous/crystalline form, repeat 2 (Part A), AZD5718 crystalline form, treatment 8 (Part A), AZD5718, crystalline form, treatment 7 (Part A) |
| AZD5718 oral suspension amorphous (1 to 100 mg/mL) (Part B)Single and multiple doses | Drug | AZD5718 amorphous form, repeat 1 (Part B), AZD5718 amorphous form, repeat 2 (Part B), AZD5718 amorphous form, treatment 1 (Part B), AZD5718 amorphous form, treatment 2 (Part B), AZD5718 amorphous form, treatment 3 (Part B), AZD5718 amorphous form, treatment 4 (Part B) |
Primary outcome
Safety and Tolerability of AZD5718 by Assessment of the Number of Participants With Adverse Events Following Oral Administration of SAD (Part A) and MAD (Part B).
Time frame: From screening to last followup visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B)
To assess the safety and tolerability of AZD5718 following oral administration of SAD (Part A) and MAD (Part B).
29 secondary outcomes
Rate and Extent of Absorption of AZD5718 by Assessment of the Area Under the Plasma Concentration-curve From Time Zero Extrapolated to Infinity (AUC) for Part A - Amorphous and Crystalline Suspension
Time frame: At post-dose (Days 1 to 3); 0.5, 1, 2, 3, 4, 6, 8, 24, 36 and 48 hours post-dose and folow up (Day 4 - 72 hours post-dose) (Part A only)
Rate and Extent of Absorption of AZD5718 by Assessment of the Area Under Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC) for Part B - Amorphous Suspension
Time frame: Day 1 of Part B
Rate and Extent of Absorption of AZD5718 by Assessment of the Area Under the Plasma Concentration-curve From Time Zero to Time of Last Quantifiable Concentration (AUC(0-last)) for Part A - Amorphous and Crystalline Suspension
Time frame: At post-dose (Days 1 to 3); 0.5, 1, 2, 3, 4, 6, 8, 24, 36 and 48 hours post-dose and folow up (Day 4 - 72 hours post-dose) (Part A only)
Rate and Extent of Absorption of AZD5718 by Assessment of the Area Under the Plasma Concentration-curve Over the Dosing Interval (AUC(0-τ)) for Part B - Amorphous Suspension
Time frame: Day 1, Day 9 and Day 10 of Part B
Rate and Extent of Absorption of AZD5718 by Assessment of the Observed Maximum Plasma Concentration (Cmax) for Part A - Amorphous and Crystalline Suspension
Time frame: At post-dose (Days 1 to 3); 0.5, 1, 2, 3, 4, 6, 8, 24, 36 and 48 hours post-dose and folow up (Day 4 - 72 hours post-dose) (Part A only)
Rate and Extent of Absorption of AZD5718 by Assessment of the Observed Maximum Plasma Concentration (Cmax) for Part B - Amorphous Suspension
Time frame: Day 1, Day 9 and Day 10 (Part B only)
Rate and Extent of Absorption of AZD5718 by Assessment of the Time to Reach the Observed Maximum Plasma Concentration (Tmax) for Part A - Amorphous and Crystalline Suspension
Time frame: At post-dose (Days 1 to 3); 0.5, 1, 2, 3, 4, 6, 8, 24, 36 and 48 hours post-dose and folow up (Day 4 - 72 hours post-dose) (Part A only)
Rate and Extent of Absorption of AZD5718 by Assessment of the Time to Reach the Observed Maximum Plasma Concentration (Tmax) for Part B - Amorphous Suspension
Time frame: Day 1, Day 9 and Day 10 (Part B only)
Rate and Extent of Absorption of AZD5718 by Assessment of the Half-life Associated With Terminal Slope of a Semi-logarithmic Plasma Concentration-time Curve (t½λz) for Part A - Amorphous and Crystalline Suspension
Time frame: At post-dose (Days 1 to 3); 0.5, 1, 2, 3, 4, 6, 8, 24, 36 and 48 hours post-dose and folow up (Day 4 - 72 hours post-dose) (Part A only)
Rate and Extent of Absorption of AZD5718 by Assessment of the Half-life Associated With Terminal Slope of a Semi-logarithmic Plasma Concentration-time Curve (t½λz) for Part B - Amorphous Suspension
Time frame: Day 1 and Day 10 (Part B only)
Rate and Extent of Absorption of AZD5718 by Assessment of the Apparent Total Body Clearance After Extravascular Administration Estimated as Dose Divided by AUC (CL/F) for Part A - Amorphous and Crystalline Suspension
Time frame: At post-dose (Days 1 to 3); 0.5, 1, 2, 3, 4, 6, 8, 24, 36 and 48 hours post-dose and folow up (Day 4 - 72 hours post-dose) (Part A only)
Rate and Extent of Absorption of AZD5718 by Assessment of the Apparent Total Body Clearance After Extravascular Administration Estimated as Dose Divided by AUC (CL/F) for Part B - Amorphous Suspension
Time frame: Day 1 and Day 10 of Part B
Rate and Extent of Absorption of AZD5718 by Assessment of the Apparent Volume of Distribution During the Terminal Phase After Extravascular Administration (Vz/F) for Part A - Amorphous and Crystalline Suspension
Time frame: At post-dose (Days 1 to 3); 0.5, 1, 2, 3, 4, 6, 8, 24, 36 and 48 hours post-dose and folow up (Day 4 - 72 hours post-dose)
To Evaluate the Relative Bioavailability Between the Amorphous and Crystalline Form of AZD5718 (Part A) by Assessment of AUC for Part A - Amorphous and Crystalline Suspension
Time frame: At post-dose (Days 1 to 3); 0.5, 1, 2, 3, 4, 6, 8,12, 24, 36, and 48 hours post-dose and folow up (Day 4 - 72 hours post-dose)
To Evaluate the Relative Bioavailability Between the Amorphous and Crystalline Form of AZD5718 (Part A) by Assessment of Cmax for Part A - Amorphous and Crystalline Suspension
Time frame: At post-dose (Days 1 to 3); 0.5, 1, 2, 3, 4, 6, 8, 24, 36 and 48 hours post-dose and folow up (Day 4 - 72 hours post-dose) (Part A only)
Rate and Extent of Absorption of AZD5718 by Assessment of the Accumulation Ratio for AUC(0-τ) (RAC AUC(0-τ)) for Part B - Amorphous Suspension
Time frame: Day 1 and Day 9 (Part B only)
Rate and Extent of Absorption of AZD5718 by Assessment of the Accumulation Ratio for Cmax (RAC Cmax) for Part B (Amorphous Suspension) Under Fasted Condition
Time frame: Day 1 and Day 9 (Part B only)
Rate and Extent of Absorption of AZD5718 by Assessment of the Temporal Change Parameter in Systemic Exposure (TCP) for Part B (Amorphous Suspension) Under Fasted Condition
Time frame: At Day 10 (Part B only)
Rate and Extent of Absorption of AZD5718 by Assessment of the Effect of Food Following Administration of 180 mg AZD5718 With Food (Part B Day 9) and Fasted (Part B Day 10)
Time frame: At Day 9 and Day 10 (Part B only)
Rate and Extent of Absorption of AZD5718 by Assessment of the Effect of Food Following Administration of 180 mg AZD5718 With Food (Part B Day 9) and Fasted (Part B Day 10)
Time frame: At Day 9 and Day 10 (Part B only)
Rate and Extent of Absorption of AZD5718 by Assessment of the Effect of Food Following Administration of 180 mg AZD5718 With Food (Part B Day 9) and Fasted (Part B Day 10)
Time frame: At Day 9 and Day 10 (Part B only)
Rate and Extent of Absorption of AZD5718 by Assessment of Cumulative Amount of Analyte Excreted at the Last Sampling Interval (CumAe0-24) Following a Single Administration of AZD5718 Amorphous and Crystalline Suspension (Part A)
Time frame: Part A pre-dose and pooled intervals up to 24 hours post-dose
Rate and Extent of Absorption of AZD5718 by Assessment of Percentage of Dose Excreted Unchanged Into the Urine From 0 to 24 Hours (Cumfe0-24) Following a Single Administration of AZD5718 Amorphous and Crystalline Suspension (Part A)
Time frame: Part A pre-dose and pooled intervals up to 24 hours post-dose
Rate and Extent of Absorption of AZD5718 by Assessment of Renal Clearance (CLR) Following a Single Administration of AZD5718 Amorphous and Crystalline Suspension (Part A)
Time frame: Part A pre-dose and pooled intervals up to 24 hours post-dose
Rate and Extent of Absorption of AZD5718 by Assessment of Cumulative Amount of Analyte Excreted From 0 to 24 Hours (CumAe0-24) Following a Multiple Daily Doses Administration of AZD5718 Amorphous Suspension (Part B Day 9)
Time frame: Part B only, Day 9 at pooled 3 hour intervals until 24 hours post-dose
Rate and Extent of Absorption of AZD5718 by Assessment of Percentage of Dose Excreted Unchanged Into the Urine From 0 to 24 Hours (Cumfe0-24) Following a Multiple Daily Doses Administration of AZD5718 Amorphous Suspension (Part B Day 9)
Time frame: Part B only, Day 9 at pooled 3 hour intervals until 24 hours post-dose
Rate and Extent of Absorption of AZD5718 by Assessment of Renal Clearance (CLR) Following a Multiple Daily Doses Administration of AZD5718 Amorphous Suspension (Part B Day 9)
Time frame: Part B only, Day 9 at pooled 3 hour intervals until 24 hours post-dose
Pharmacodynamic Analysis by ex Vivo Stimulation of Leukotriene B4 (LTB4) Production Using Calcium Ionophore for Part A -Amorphous and Crystalline Suspension
Time frame: Admission to 0.5, 1, 2, 3, 4, 6, 8, 24, 36 and 48 hours post-dose (Part A only)
Pharmacodynamic Analysis by ex Vivo Stimulation of LTB4 Production Using Calcium Ionophore for Part B - Amorphous Suspension
Time frame: Admission, predose and 0.5, 1, 2, 3, 4, 6, 8, 24, 36 and 48 hours post-dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Annelize Koch, MBChB, FFPM principal investigator
Parexel
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 AZD5718 oral suspension crystalline form (1 to 100 mg/mL) (Part A), AZD5718 oral suspension amorphous (1 to 100 mg/mL) (Part A) and AZD5718 oral suspension amorphous (1 to 100 mg/mL) (Part B) in people with Healthy Male Subjects and Cardiovascular 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 4 inclusion and 37 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 21 Mar 2019. 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?
Yes. Results are posted in the registry (first posted 21 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Safety and Tolerability of AZD5718 by Assessment of the Number of Participants With Adverse Events Following Oral Administration of SAD (Part A) and MAD (Part B). (time frame: From screening to last followup visit (7-10 days after last dose), up to 6 weeks (Part A) and up to 8 weeks (Part B)). 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 21 Mar 2019.