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
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