Open Label Study, Assessing the Effect of Diltiazem or Ketoconazole on the Pharmacokinetics of AZD9742 in Healthy Volunteers

Phase 1

Completed

• Conditions: Pharmacokinetics
• Interventions: Drug: AZD9742; Drug: Diltiazem; Drug: ketoconazole

• Registration Number: NCT01124760
• Lead Sponsor: AstraZeneca

Brief Summary

The aim of this study is to examine the effect of coadministration of CYP3A4 inhibitors on the pharmacokinetics of AZD9742.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2010-05-13
• Study First Submitted QC: 2010-05-14
• Study First Posted: 2010-05-17
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Status Verified: 2010-08
• Last Update Submitted: 2010-08-02
• Last Update Posted: 2010-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

• non-childbearing potential, with suitable veins for cannulation or repeated venipuncture
• Females must have a negative pregnancy test at screening and on admission to the unit, must not be lactating and must be of non-childbearing potential, confirmed at screening.
• Male volunteers should be willing to use barrier contraception, ie, condoms, from the day of dosing until 3 months after dosing with the investigational product.

Exclusion Criteria

• History of any clinically significant 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
• History or presence of GI, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs as judged by Investigator.
• Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of investigational product

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	Diltiazem	AZD9742
1	ketoconazole	AZD9742
1	AZD9742	AZD9742

Primary Outcome Measures

Name	Time	Method
Determine the effect of coadministration of CYP3A4 inhibitors (diltiazem and ketoconazole) on the pharmacokinetics of AZD9742 in blood and urine.	For diltiazem group - up to 18 days of pre-defined study days for pk profiling. For keoconazole - up to 14 days of pre-defined study days for pk profiling.

Secondary Outcome Measures

Name	Time	Method
Safety variables (adverse events, vital signs, physical examinations, clinical laboratory assessments, 12-lead ECG, telemetry)	Collected prior to treatment, during treatment, and follow-up for a maximum of 57 days for group 1 and 53 days for group 2 (this includes up to 28 days for screening).

Trial Locations

Locations (1)

Research Site; 🇺🇸 Overland Park, Kansas, United States