AzTrials
AzTrials

AsthmaPhase 1NCT02645253

A Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD7594 Inhaled Formulation in Healthy Japanese Men

A Phase 1 study testing AZD7594 inhalation powder (200 μg), AZD7594 inhalation powder (400 μg) and AZD7594 pressurized inhalation suspension (200 μg) in people with Asthma and Chronic Obstructive Pulmonary Disease COPD, run by AstraZeneca at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This is a randomized, single-blind, placebo-controlled, sequential-group study to assess the safety and tolerability as well as how the drug (AZD7594) affects the body (pharmacodynamics [PD]) and how the body affects the drug (pharmacokinetics [PK]) when AZD7594 is given as single and multiple ascending doses once… Read more about this study

Who is it for?
Ages 20 to 45 years, men onlyHealthy volunteers can take part
What is being tested?
AZD7594 inhalation powder (200 μg), AZD7594 inhalation powder (400 μg) and AZD7594 pressurized inhalation suspension (200 μg)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
27 participants
Where
1 siteUnited States
Study dates
12 Jan 2016to 17 Apr 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 20 to 45 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 Japanese subjects aged 20 to 45 years with suitable veins for cannulation or repeated venipuncture.
  • A Japanese male subject is defined as being born in Japan, having both parents and four grandparents who are Japanese. The subject must not have lived outside of Japan for more than 5 years.
  • Have a body mass index (BMI) between 18 and 30 kg/m2 inclusive and weigh at least 45 kg and no more than 100 kg inclusive.
  • Provision of signed, written and dated informed consent for optional genetic research Note: 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 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 first administration of investigational drug administration.
  • Any contraindication against the use of vagolytic or sympaticomimetic drugs, as judged by the investigator.
  • Any clinically significant abnormalities in clinical chemistry, hematology, urinalysis, physical examination, vital signs, electrocardiogram (ECG) or lung function results at baseline, as judged by the investigator.
  • Known Gilbert's syndrome, family history of Gilbert's syndrome or suspicion of Gilbert's syndrome based on liver function tests.
Show all 38Show fewer
  • Use of systemic glucocorticosteroids within 6 weeks of enrollment.
  • Any positive result on screening for serum hepatitis B surface antigen (HBsAg), hepatitis C antibody and human immunodeficiency virus (HIV).
  • Known or suspected hypersensitivity to investigational product or excipients.
  • Plasma donation within one month of screening or any blood donation/blood loss > 500 mL during the 3 months prior to screening.
  • Abnormal vital signs, after 10 minutes supine rest, defined as any of the following:
  • Systolic blood pressure (BP) < 90mmHg or > 140 mmHg
  • Diastolic BP < 60mmHg or > 90 mmHg
  • Pulse rate < 40 or > 85 beats per minute (bpm)
  • Any clinically significant abnormalities 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 QT interval corrected for heart rate (HR) using Fridericia's formula (QTcF) > 450 ms or family history of long QT syndrome.
  • PR(PQ) interval shortening < 120 ms (PR > 110 ms but < 120 ms is acceptable if there is no evidence of ventricular pre-excitation).
  • PR (PQ) interval prolongation (> 240 ms) intermittent second (Wenckebach block while asleep is not exclusive) or third degree AV block, or AV dissociation.
  • 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.
  • 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 previous 3 months.
  • History of alcohol abuse or excessive intake of alcohol, as judged by the investigator.
  • Positive screen for drugs of abuse 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 ADZ7594.
  • 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 investigational drug.
  • 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 first administration of investigational drug or longer if the medication has a long half-life.
  • Has received another new chemical entity (defined as a compound which has not been approved for marketing in the US) within 30 days or at least 5 half-lives (whichever is longer) of the first administration of investigational drug in this study. The period of exclusion begins 3 months after the final dose or 1 month after the last visit whichever is the longest.
  • Note: Subjects consented and screened, but not randomized in this study or a previous phase I study, are not excluded.
  • Vulnerable subjects, e.g., kept in detention, protected adults under guardianship, trusteeship, or committed to an institution by governmental or juridical order.
  • Subjects who have previously received AZD7594.
  • Involvement of any Astra Zeneca 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. It is acceptable to make use of an interpreter. The informed consent document (ICD) must be available in the Japanese language.
  • 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.

United States1 site

  • Research Site

    Glendale, California, 91206

Other trials in United States

About this study

Official title: A Phase I, Randomized, Single-blind, Placebo-controlled, Sequential-group, Single-center Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Ascending Doses of AZD7594 Given Once Daily as Inhaled Formulation in Healthy Japanese Men

This is a randomized, single-blind, placebo-controlled, sequential-group study to assess the safety and tolerability as well as how the drug (AZD7594) affects the body (pharmacodynamics [PD]) and how the body affects the drug (pharmacokinetics [PK]) when AZD7594 is given as single and multiple ascending doses once daily by inhalation to healthy male Japanese subjects, compared with placebo (non-active drug)

Read the detailed description

This is a phase I, randomized, single-blind, placebo controlled, sequential-group design study to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of AZD7594 after single and multiple ascending doses given once daily by inhalation in healthy male Japanese subjects, compared with placebo

Being tested
AZD7594 inhalation powder (200 μg), AZD7594 inhalation powder (400 μg), AZD7594 pressurized inhalation suspension (200 μg), AZD7594 placebo inhalation powder, AZD7594 placebo pressurized inhalation suspension
Keywords
Safety, Pharmacokinetics, Pharmacodynamics, Glucocorticoid receptor modulator, Healthy male subjects
Medical subject headings
Asthma, Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AZD7594 inhalation powder (200 μg)Drug

    200 μg AZD7594 inhalation powder via multi-dose dry powder inhaler (DPI)

  • AZD7594 inhalation powder (400 μg)Drug

    Cohort 2: 400 μg AZD7594 inhalation powder via multi-dose DPI Cohort 3: 1600 μg (4 x 400 μg inhalations) AZD7594 inhalation powder via multi-dose DPI

  • AZD7594 pressurized inhalation suspension (200 μg)Drug

    400 μg (2 x 200 μg inhalations) AZD7594 pressurized inhalation suspension via pressurized metered dose inhaler (pMDI)

  • AZD7594 placebo inhalation powderDrug

    AZD7594 placebo inhalation powder via multi-dose DPI

  • AZD7594 placebo pressurized inhalation suspensionDrug

    AZD7594 placebo pressurized inhalation suspension via pressurized metered dose inhaler (pMDI)

Study groups in NCT02645253
Study groupRoleWhat they receive
Cohort 1ExperimentalAZD7594 inhalation powder (200 μg) or AZD7594 placebo inhalation powder via multi-dose dry powder inhaler (DPI)
Receives: Drug: AZD7594 inhalation powder (200 μg); Drug: AZD7594 placebo inhalation powder
Cohort 2ExperimentalAZD7594 inhalation powder (400 μg) or AZD7594 placebo inhalation powder via multi-dose dry powder inhaler (DPI)
Receives: Drug: AZD7594 inhalation powder (400 μg); Drug: AZD7594 placebo inhalation powder
Cohort 3Experimental1600 μg AZD7594 inhalation powder (4 x 400 μg) or AZD7594 placebo inhalation powder via multi-dose dry powder inhaler (DPI)
Receives: Drug: AZD7594 inhalation powder (400 μg); Drug: AZD7594 placebo inhalation powder
Cohort 4Experimental400 μg AZD7594 pressurized inhalation suspension (2 x 200 μg inhalations) or placebo pressurized inhalation suspension via pressurized metered dose inhaler (pMDI)
Receives: Drug: AZD7594 pressurized inhalation suspension (200 μg); Drug: AZD7594 placebo pressurized inhalation suspension

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety and Tolerability of AZD7594 by Assessment of the Number of Participants With Adverse Events

    To assess the safety and tolerability of single and multiple doses of AZD7594

    Measured: At screening (Day -28, Day -02 and Day -1), Treatment period (Days 1 to 20) and Follow-up (Day 29).

Secondary outcomes (34)

  1. Rate and Extent of Absorption of AZD7594 (Inhalation/ Administration Via DPI) by Assessment of the Observed Maximum Plasma Concentration (Cmax)

    Assessment of the plasma PK following a single dose of AZD7594.

    Cmax was defined as observed maximum plasma concentration, taken directly from the individual concentration-time curve.

    Measured: Day 1: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose.

  2. Rate and Extent of Absorption of AZD7594 (Inhalation/ Administration Via DPI) by Assessment of the Time to Reach Maximum Plasma Concentration (Tmax)

    Assessment of the plasma PK following a single dose of AZD7594.

    tmax was defined as time to reach maximum plasma concentration, taken directly from the individual concentration-time curve.

    Measured: Day 1: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose.

  3. Rate and Extent of Absorption of AZD7594 (Inhalation/ Administration Via DPI) by Assessment of the Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to the Time of Last Quantifiable Analyte Concentration (AUC [0-last])

    Assessment of the plasma PK following a single dose of AZD7594.

    AUC (0-last) was defined as the area under the plasma concentration-time curve from time zero to the time of last quantifiable analyte concentration.

    Measured: Day 1: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose

  4. Rate and Extent of Absorption of AZD7594 (Inhalation/ Administration Via DPI) by Assessment of the AUC From Time Zero to 24 Hours After Dosing (AUC [0-24]).

    Assessment of the plasma PK following a single dose of AZD7594.

    AUC (0-24) was defined as area under the plasma concentration-time curve from time zero to 24 hours after dosing.

    Measured: Day 1: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose

  5. Rate and Extent of Absorption of AZD7594 (Inhalation/ Administration Via DPI) by Assessment of the AUC From Time Zero Extrapolated to Infinity (AUC).

    Assessment of the plasma PK following a single dose of AZD7594.

    AUC was defined as area under the plasma concentration-time curve from time zero extrapolated to infinity. AUC is estimated by AUC(0-last) + Clast/λz where Clast is the last observed quantifiable concentration.

    NOTE: No results were available for participants belonging to AZD7594 2ug and AZD7594 400ug groups.

    Measured: Day 1: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose

  6. Rate and Extent of Absorption of AZD7594 by Assessment of the Terminal Elimination Rate Constant, Estimated by Log-linear Least Squares Regression of the Terminal Part of the Concentration-time Curve(Lamda z or λz).

    Assessment of the plasma PK following a single dose of AZD7594.

    λz was defined as terminal elimination rate constant, estimated by log-linear least squares regression of the terminal part of the concentration-time curve.

    Measured: Day 1: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose

  7. Rate and Extent of Absorption of AZD7594 (Inhalation/ Administration Via DPI) by Assessment of the Half-life Associated With the Terminal Slope of a Semi-logarithmic Concentration-time Curve (t1/2λz).

    Assessment of the plasma PK following a single dose of AZD7594.

    t1/2λz was defined as half-life associated with terminal slope (λz) of a semi-logarithmic concentration-time curve.

    NOTE: No results were available for participants belonging to AZD7594 400ug group.

    Measured: Day 1: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose

  8. Rate and Extent of Absorption of AZD7594 (Inhalation/ Administration Via DPI) by Assessment of the Mean Residence Time From Time Zero Extrapolated to Infinity (MRT).

    Assessment of the plasma PK following a single dose of AZD7594.

    MRT was defined as Mean residence time from time zero extrapolated to infinity.

    NOTE: No results were available for participants belonging to AZD7594 200ug and AZD7594 400ug groups.

    Measured: Day 1: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose

  9. Rate and Extent of Absorption of AZD7594 by Assessment of the Apparent Total Body Clearance After Extravascular Administration Estimated as Dose Divided by AUC (AZD7594) (CL/F).

    Assessment of the plasma PK following a single dose of AZD7594.

    CL/F was defined as apparent total body clearance after extravascular administration estimated as dose divided by AUC (AZD7594).

    NOTE: No results were available for participants belonging to AZD7594 200ug and AZD7594 400ug groups.

    Measured: Day 1: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose.

  10. Rate and Extent of Absorption of AZD7594 by Assessment of the Apparent Volume of Distribution During the Terminal Phase After Extravascular Administration, Estimated by Dividing CL/F by Lamda z (Vz/F)

    Assessment of the plasma PK following a single dose of AZD7594.

    Vz/F was defined as apparent volume of distribution during the terminal phase after extravascular administration, estimated by dividing the apparent clearance (CL/F) by λz.

    NOTE: No results were available for participants belonging to AZD7594 200ug and AZD7594 400ug groups.

    Measured: Day 1: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose.

  11. Rate and Extent of Absorption of AZD7594 by Assessment of the Cmax Divided by the Dose Administered (Cmax/D).

    Assessment of the plasma PK following a single dose of AZD7594.

    Cmax/D was defined as observed maximum plasma concentration divided by the dose administered.

    Measured: Day 1: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose

  12. Rate and Extent of Absorption of AZD7594 by Assessment of the AUC Divided by the Dose Administered (AUC/D).

    Assessment of the plasma PK following a single dose of AZD7594.

    AUC/D was defined as Area under the plasma concentration-time curve from time zero extrapolated to infinity divided by the dose administered.

    NOTE: No results were available for participants belonging to AZD7594 200ug and AZD7594 400ug groups.

    Measured: Day 1: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose.

  13. Rate and Extent of Absorption of AZD7594 by Assessment of the AUC(0-24) Divided by the Dose Administered (AUC(0-24)/D)

    Assessment of the plasma PK following a single dose of AZD7594.

    AUC(0-24)/D was defined as area under the plasma concentration-time curve from time zero to 24 hours after dosing divided by the dose administered.

    Measured: Day 1: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose.

  14. Rate and Extent of Absorption of AZD7594 by Assessment of the Observed Minimum Plasma Concentration (Cmin)

    Cmin was defined as observed minimum plasma concentration, taken directly from the individual concentration-time curve

    Measured: Days 5 to 15: Pre-dose

  15. Rate and Extent of Absorption of AZD7594 (Inhalation/ Administration Via DPI) by Assessment of the Cmax at Steady State (Css,Max).

    Assessment of the plasma PK following a single dose of AZD7594.

    Css,max was defined as observed maximum plasma concentration at steady state, taken directly from the individual concentration-time curve.

    Measured: Day 16: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose

  16. Rate and Extent of Absorption of AZD7594 (Inhalation/ Administration Via DPI) by Assessment of the Cmin at Steady State (Cmin, ss)

    Assessment of the plasma PK following a single dose of AZD7594.

    Cmin, ss was defined as observed minimum concentration, taken directly from the individual concentration-time curve.

    Measured: Day 16: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose.

  17. Rate and Extent of Absorption of AZD7594 (Inhalation/ Administration Via DPI) by Assessment of the Average Concentration Over One Dosing Interval (Cav)

    Assessment of the plasma PK following a single dose of AZD7594.

    Cav was defined as average concentration over one dosing interval.

    Measured: Day 16: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose.

  18. Rate and Extent of Absorption of AZD7594 (Inhalation/ Administration Via DPI) by Assessment of the Tmax at Steady State (Tss,Max).

    Assessment of the plasma PK following a single dose of AZD7594.

    tss,max was defined as Time to reach maximum concentration, taken directly from the individual concentration-time curve.

    Measured: Day 16: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose.

  19. Rate and Extent of Absorption of AZD7594 by Assessment of the AUC(0-last)

    Assessment of the plasma PK following a single dose of AZD7594.

    AUC(0-last) was defined as Area under the plasma concentration-time curve from time zero to the time of the last quantifiable analyte concentration.

    Measured: Day 16: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose.

  20. Rate and Extent of Absorption of AZD7594 by Assessment of AUC(0-24)

    Assessment of the plasma PK following a single dose of AZD7594.

    AUC(0-24) was defined as area under the plasma concentration-time curve from time zero to 24 hours after dosing

    Measured: Day 16: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose.

  21. Rate and Extent of Absorption of AZD7594 by Assessment of the Css,Max Divided by the Dose Administered (Css,Max/D).

    Assessment of the plasma PK following a single dose of AZD7594.

    Css,max/D was defined as observed maximum plasma concentration divided by the dose administered.

    Measured: Day 16: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose.

  22. Rate and Extent of Absorption of AZD7594 by Assessment AUC(0-24)/D.

    Assessment of the plasma PK following a single dose of AZD7594.

    AUC(0-24)/D was defined as the area under the plasma concentration-time curve from time zero to 24 hours after dosing divided by the dose administered.

    Measured: Day 16: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose.

  23. Rate and Extent of Absorption of AZD7594 by Assessment of Lamda z (λz)

    Assessment of the plasma PK following a single dose of AZD7594.

    λz was defined as terminal elimination rate constant, estimated by log-linear least.

    Measured: Day 16: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose.

  24. Rate and Extent of Absorption of AZD7594 by Assessment of t1/2λz.

    Assessment of the plasma PK following a single dose of AZD7594.

    t1/2λz was defined as half-life associated with terminal slope (λz) of a semi-logarithmic concentration-time curve.

    Participant count analyzed = 1

    Measured: Day 16: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose

  25. Rate and Extent of Absorption of AZD7594 by Assessment of the Peak Trough Fluctuation (%Fluctuation).

    Assessment of the plasma PK following a single dose of AZD7594.

    Peak trough fluctuation calculated as [100*(Css,max- Css,min)/Cav].

    Measured: Day 16: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose.

  26. Rate and Extent of Absorption of AZD7594 by Assessment of the Accumulation Ratio Calculated as AUC(0-24) on Day 16/AUC (0-24) on Day 1 (RAC).

    Assessment of the plasma PK following a single dose of AZD7594.

    Accumulation ratio calculated as AUC(0-24) on Day 16/AUC(0-24) on Day 1.

    Measured: Day 16: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose.

  27. Rate and Extent of Absorption of AZD7594 by Assessment of the Temporal Change Parameter (TCP)

    Assessment of the plasma PK following a single dose of AZD7594.

    Temporal change parameter, calculated as AUC(0-24) [Day 16]/AUC [Day 1].

    NOTE: No results were available for participants belonging to AZD7594 200ug and AZD7594 400ug groups.

    Measured: Day 16: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post-dose.

  28. Rate and Extent of Absorption of AZD7594 by Assessment of the Amount of AZD7594 Excreted Into the Urine From Time t1 to t2 (Ae [t1-t2])

    Assessment of the urine PK following a single dose of AZD7594.

    Ae (t1-t2) was defined as the amount of AZD7594 excreted into the urine from time t1 to t2.

    Measured: Day 1 predose spot-collection and interval collection up to 96 hours postdose

  29. Rate and Extent of Absorption of AZD7594 by Assessment of the Cumulative Amount of AZD7594 Excreted From Time Zero to the Last Sampling Interval (Ae [0-last])

    Assessment of the urine PK following a single dose of AZD7594.

    Ae(0-last) was defined as Cumulative amount of AZD7594 excreted from time zero to the last sampling interval.

    Measured: Day 1 predose spot-collection and interval collection up to 96 hours postdose

  30. Rate and Extent of Absorption of AZD7594 by Assessment of the Percentage of Dose Excreted Unchanged Into the Urine From Time Zero to the Last Measured Time Point for an AZD7594, Estimated by Dividing Ae(0-last) by Dose (fe(0-last)%)

    Assessment of the urine PK following a single dose of AZD7594.

    fe(0-last)% was defined as Percentage of dose excreted unchanged into the urine from time zero to the last measured time point for an AZD7594, estimated by dividing Ae(0-last) by dose.

    Measured: Day 1 predose spot-collection and interval collection up to 96 hours postdose

  31. Rate and Extent of Absorption of AZD7594 by Assessment of the Renal Clearance, Estimated by Dividing Ae(0-96) by AUC(0-96) (CLR)

    Assessment of the urine PK following a single dose of AZD7594.

    CLR was defined as the renal clearance, estimated by dividing Ae(0-96) by AUC(0-96).

    Measured: Day 1 predose spot-collection and interval collection up to 96 hours postdose

  32. Pharmacodynamic Analysis of AZD7594 by Assessment of the Area Under the Effect Curve for Plasma Cortisol From Time Zero to 24 Hours After Dosing (AUEC [0-24]).

    Assessment of the plasma pharmacodynamics (PD) effects of AZD7594 after single and multiple ascending inhaled doses.

    AUEC(0-24) was defined as area under the effect curve for plasma cortisol from time zero to 24 hours after dosing.

    Measured: Day -1 (- 24 hours predose) up to 24 hours postdose; Day 1 and Day 16

  33. Pharmacodynamic Analysis of AZD7594 by Assessment of Plasma Concentration of Dehydroepiandrosterone Sulphate (DHEAS)

    Assessment of the plasma PD following a single dose of AZD7594

    Measured: Day 1 (predose) and Day 16 (24 hours postdose)

  34. Pharmacodynamic Analysis of AZD7594 by Assessment of Plasma Concentration of Osteocalcin

    Assessment of the plasma PD following a single dose of AZD7594

    Measured: Day 1 (predose) and Day 16 (24 hours postdose)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jan 2016 (estimated)
  2. Study start12 Jan 2016
  3. Primary completion17 Apr 2016
  4. Study completion17 Apr 2016

Resources

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
Investigator
Enrolment
27 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02645253
Sponsor's protocol ID
D3741C00005
Status last verified
Aug 2017
First submitted
23 Dec 2015
Last updated
19 Feb 2018
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing AZD7594 inhalation powder (200 μg), AZD7594 inhalation powder (400 μg) and AZD7594 pressurized inhalation suspension (200 μg) in people with Asthma and Chronic Obstructive Pulmonary Disease COPD, run by AstraZeneca at 1 site in United States.

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 5 inclusion and 38 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 19 Feb 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 States. 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 19 Feb 2018). 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 AZD7594 by Assessment of the Number of Participants With Adverse Events (time frame: At screening (Day -28, Day -02 and Day -1), Treatment period (Days 1 to 20) and Follow-up (Day 29).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02645253.

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 19 Feb 2018.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in