- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01889160
Study to Investigate the Safety Profile of AZD4721 After Single Doses at Different Dose Levels
A Phase I Single-blind, Randomised, Placebo-controlled, Single-centre Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Oral AZD4721 Solution After Single Ascending Doses, and to Compare the Oral Bioavailability of Single Doses of Solution and Suspension in Healthy Subjects
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
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London, United Kingdom
- Research Site
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Healthy male and/or female Caucasian (neither Black/African American nor Japanese) volunteers aged 18-50 years. ("Healthy" is as determined by medical history and physical examination, clinical laboratory parameters, and ECG )
- Females must have a negative pregnancy test at screening and on admission to the unit, must not be lactating and must be of nonchildbearing potential
- Volunteers should have a BMI between 18 and 30 kg/m2 (inclusive) and weigh at least 50 kg and no more than 100 kg (inclusive).
Exclusion Criteria:
- History of any clinically important disease or disorder which, in the opinion of the Investigator, may either put the volunteer at risk because of participation in the study, or influence the results or the volunteer's ability to participate
- Current smokers or those who have smoked or used nicotine products within the previous 3 months
2.Clinically significant lower respiratory tract infection not resolved within 4 weeks prior to Visit 1, as determined by the Investigator
4. Other latent or chronic infections (eg, recurrent sinusitis, genital or ocular herpes, urinary tract infection) or at risk of infection (surgery, trauma, or significant infection) in previous 90 days, or history of skin abscesses within the previous
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Part A Active
AZD4721 Solution
|
1-9 mg/mL liquid solution
|
Placebo Comparator: Part A Placebo
Placebo for AZD4721
|
Liquid solution
|
Experimental: Part B solution
AZD4721 Solution
|
1-9 mg/mL liquid solution
|
Active Comparator: Part B Suspension
AZD4721 Suspension
|
9 mg/g liquid suspension
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Description of the safety profile in terms of Adverse events; blood pressure, heart rate and body temperature; electrocardiograms; clinical chemistry; haematology assessments, including serial blood neutrophil count
Time Frame: From Screening to follow up ( maximum 7 weeks)
|
From Screening to follow up ( maximum 7 weeks)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Description of the pharmacokinetic(PK) profile for in terms of: observed maximum plasma concentration (Cmax), time to reach maximum plasma concentration (tmax), terminal rate constant (λz), terminal half-life (t½ z).
Time Frame: Sample taken predose, 1, 3, 5, 7, 9, 13, 18, 24, 36, 48, 72, 96, 144, 216 hours postdose
|
Sample taken predose, 1, 3, 5, 7, 9, 13, 18, 24, 36, 48, 72, 96, 144, 216 hours postdose
|
Description of the pharmacokinetic(PK) profile for in terms of: area under the plasma concentration-time curve from time zero to 24 hours after dosing (AUC(0-24)), from time zero to the time of last quantifiable concentration (AUC(0 last))
Time Frame: Sample taken predose, 1, 3, 5, 7, 9, 13, 18, 24, 36, 48, 72, 96, 144, 216 hours postdose
|
Sample taken predose, 1, 3, 5, 7, 9, 13, 18, 24, 36, 48, 72, 96, 144, 216 hours postdose
|
Description of the pharmacokinetic(PK) profile for in terms of from time zero extrapolated to infinity (AUC), apparent clearance for parent drug estimated as dose divided by AUC (CL/F; AZD4721 only)
Time Frame: Sample taken predose, 1, 3, 5, 7, 9, 13, 18, 24, 36, 48, 72, 96, 144, 216 hours postdose
|
Sample taken predose, 1, 3, 5, 7, 9, 13, 18, 24, 36, 48, 72, 96, 144, 216 hours postdose
|
Description of the pharmacokinetic(PK) profile in terms of apparent volume of distribution during terminal phase (Vz/F; AZD4721 only), mean residence time (MRT, AZD4721 only), lag-time (T-lag, AZD4721 only), dose-normalized AUC (AUC/D) and Cmax (Cmax/D)
Time Frame: Sample taken predose, 1, 3, 5, 7, 9, 13, 18, 24, 36, 48, 72, 96, 144, 216 hours postdose
|
Sample taken predose, 1, 3, 5, 7, 9, 13, 18, 24, 36, 48, 72, 96, 144, 216 hours postdose
|
Description of the pharmacokinetic(PK) profile for in terms of effective half-life (t½(eff)), time of last quantifiable concentration (tlast), predicted accumulation ratio (Rac,pred)
Time Frame: Sample taken predose, 1, 3, 5, 7, 9, 13, 18, 24, 36, 48, 72, 96, 144, 216 hours postdose
|
Sample taken predose, 1, 3, 5, 7, 9, 13, 18, 24, 36, 48, 72, 96, 144, 216 hours postdose
|
Description of the pharmacokinetic(PK) profile for in terms of the time interval and number of data points included in the log-linear regression to determine terminal half-life (z,Interval and z,N)
Time Frame: Sample taken predose, 1, 3, 5, 7, 9, 13, 18, 24, 36, 48, 72, 96, 144, 216 hours postdose
|
Sample taken predose, 1, 3, 5, 7, 9, 13, 18, 24, 36, 48, 72, 96, 144, 216 hours postdose
|
Description of the pharmacokinetic(PK) profile for in terms of the regression coefficient for calculation of the terminal rate constant (Rsq), and the percentage of area under the curve to infinity obtained by extrapolation (%AUCex).
Time Frame: Sample taken predose, 1, 3, 5, 7, 9, 13, 18, 24, 36, 48, 72, 96, 144, 216 hours postdose
|
Sample taken predose, 1, 3, 5, 7, 9, 13, 18, 24, 36, 48, 72, 96, 144, 216 hours postdose
|
Description of the pharmacokinetic(PK) profile for in terms of the metabolic ratios (ratio of metabolite to parent) for AUC and Cmax (MRAUC and MRCmax)
Time Frame: Sample taken predose, 1, 3, 5, 7, 9, 13, 18, 24, 36, 48, 72, 96, 144, 216 hours postdose
|
Sample taken predose, 1, 3, 5, 7, 9, 13, 18, 24, 36, 48, 72, 96, 144, 216 hours postdose
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: James Ritter, MD, Quintiles London UK
- Study Director: Bengt Larsson, MD, AstraZeneca Mölndal, Sweden
- Study Chair: Stuart Oliver, MD, AstraZeneca UK
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- D5200C00001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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