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

Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pharmacokinetics

Intervention: AZD9742 (Drug); Diltiazem (Drug); ketoconazole (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Ralph Schutz, MD, Principal Investigator, Affiliation: Quintiles
Colleen Jensen, Study Director, Affiliation: AstraZeneca
Brendan Smyth, Study Chair, Affiliation: AstraZeneca

Summary

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

Clinical Details

Official title: A Phase I, Single Center, Open Label, 2-consecutive-group, 2-period, 1-sequence Crossover Study to Assess the Effect of Diltiazem (Cardizem), a Moderate CYP3A4 Inhibitor, or Ketoconazole, a Potent CYP3A4 Inhibitor, on the Pharmacokinetics of a Single Intravenous Dose of 150mg of AZD9742.

Study design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Determine the effect of coadministration of CYP3A4 inhibitors (diltiazem and ketoconazole) on the pharmacokinetics of AZD9742 in blood and urine.

Secondary outcome: Safety variables (adverse events, vital signs, physical examinations, clinical laboratory assessments, 12-lead ECG, telemetry)

Eligibility

Minimum age: 23 Years. Maximum age: 45 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

Research Site, Overland Park, Kansas, United States
Additional Information

Starting date: May 2010
Last updated: August 2, 2010

Page last updated: August 23, 2015

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