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 safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01735240|
Recruitment Status : Completed
First Posted : November 28, 2012
Last Update Posted : June 25, 2015
|Condition or disease||Intervention/treatment||Phase|
|Asthma, Pharmacokinetics, Cmax, Tmax, λz, AUC, Ketoconazole, Metabolite||Drug: AZD5069 Drug: Ketoconazole||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (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|
|Study Start Date :||December 2012|
|Actual Primary Completion Date :||February 2013|
|Actual Study Completion Date :||February 2013|
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)
- 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. ](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. ]
- 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 ]
- 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 ]Measures: laboratory assessments (clinical chemistry, haematology, urinalysis), vital signs (blood pressure, pulse rate, including body temperature), physical examination and 12-led electrocardiogram.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|