Phase I Study to Assess the Effect on Healthy Male Volunteers of Ketoconazole on the Pharmacokinetics of a Single Dose of AZD5069 Administered Orally.
The main purpose of the study is to compare the change of the AZD5069 Pharmacokinetic profile when administered with ketoconazole. Subjects will be treated first with AZD5069 only followed by a washout period before starting with the combined treatment (both ketoconazole and AZD5069).
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
|Official Title:||An Open-label, Fixed-sequence, Single-centre Phase I Study to Assess the Effect of Ketoconazole on the Pharmacokinetics of AZD5069 After Oral Administration of a Single Dose AZD5069 to Healthy Male Volunteers|
- Pharmacokinetics of AZD5069 (15 mg) and a metabolite (AZ13587715) measured by AUC, AUC(0-t), Cmax, λz, t½λz, tmax, CL/F (AZD5069 only), Vz/F (alone and in combination with Ketoconazole) [ Time Frame: Day 1, Day 2 at 24 hours post dose and Day 3 at 48 hours post dose in period 1 and Day 1, 2, 3 at 48 hours post dose and Day 4 at 72 post dose in period 2. ] [ Designated as safety issue: No ](AUC(0-t)) area under the plasma concentration-time curve from time zero to time of last quantifiable concentration, (Cmax) observed maximum plasma concentration, (λz) terminal rate constant, (t½λz) terminal half-life, (tmax) time to reach maximum plasma concentration (tmax), (CL/F) apparent oral clearance (AZD5069 only), (Vz/F) apparent volume of distribution.
- Pharmacokinetics of Ketoconazole measured by AUC(0-t) and Cmax (in combination with AZD5069) [ Time Frame: Day 1, 2, 3 at 48 hours post dose and Day 4 at 72 post dose in period 2. ] [ Designated as safety issue: No ]
- Numbers of circulating neutrophil in blood measured by AZD5069 administration alone and in combination with Ketoconazole [ Time Frame: Day 1, 2, 3 at predose, 4, 8, 12, 24, 48 hours post dose in period 1 and Day 1, 2, 3, 4 at predose, 4, 8, 12, 24, 48 hours post dose ] [ Designated as safety issue: Yes ]
- Safety of AZD5069 (15 mg) in combination with Ketoconazole by assessing a panel of adverse events measures: laboratory assessments, vital signs, physical examination and 12-led electrocardiogram. [ Time Frame: Up to 2 months ] [ Designated as safety issue: Yes ]Measures: laboratory assessments (clinical chemistry, haematology, urinalysis), vital signs (blood pressure, pulse rate, including body temperature), physical examination and 12-led electrocardiogram.
|Study Start Date:||December 2012|
|Study Completion Date:||February 2013|
|Primary Completion Date:||February 2013 (Final data collection date for primary outcome measure)|
Experimental: First AZD5069, then Ketoconazole + AZD5069
AZD5069 in first period (on 1 day) and in second period (after wash out) ketoconazole alone (on 2 days) then ketoconazole + AZD5069 (on 1 day), then again ketoconazole alone (on 2 days)
AZD5069 15 mg (3x5 mg capsules) single administrationDrug: Ketoconazole
Ketoconazole 400 mg (2x200 mg tablets)
An open-label, fixed-sequence, single-centre phase I study to assess the effect of ketoconazole on the pharmacokinetics of AZD5069 after oral administration of a single dose AZD5069 to healthy male volunteers
Please refer to this study by its ClinicalTrials.gov identifier: NCT01735240
|London, United Kingdom|
|Study Director:||Bengt Larsson, Dr.||AstraZeneca Pharmaceutical|
|Study Chair:||Gillian Pilbrow||AstraZeneca Pharmaceutical|
|Principal Investigator:||Leonard Siew, DR.||Quintiles Drug Research Unit at Guy's Hospital|