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

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ClinicalTrials.gov Identifier: NCT01124760
Recruitment Status : Completed
First Posted : May 17, 2010
Last Update Posted : August 3, 2010
Sponsor:
Information provided by:
AstraZeneca

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

Condition or disease Intervention/treatment Phase
Pharmacokinetics Drug: AZD9742 Drug: Diltiazem Drug: ketoconazole Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : May 2010
Actual Primary Completion Date : July 2010
Actual Study Completion Date : July 2010

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1
AZD9742
Drug: AZD9742
Sterile solution, 620 mg (20 mg/mL) in 50 mL vial with a fill volume of 31 mL; On Day 7, a single 150 mg IV dose, coadministered after the morning dose of ketoconazole

Drug: Diltiazem
Orally, daily beginning on Day 4 for 14 consecutive days
Other Name: Myoderm

Drug: ketoconazole
200 mg, orally, every 12 hours starting on Day 4 for 10 consecutive days in which on Day 13 only the morning dose will be administered




Primary Outcome Measures :
  1. Determine the effect of coadministration of CYP3A4 inhibitors (diltiazem and ketoconazole) on the pharmacokinetics of AZD9742 in blood and urine. [ Time Frame: 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 :
  1. Safety variables (adverse events, vital signs, physical examinations, clinical laboratory assessments, 12-lead ECG, telemetry) [ Time Frame: 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). ]


Information from the National Library of Medicine

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Ages Eligible for Study:   23 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

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): NCT01124760


Locations
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United States, Kansas
Research Site
Overland Park, Kansas, United States
Sponsors and Collaborators
AstraZeneca
Investigators
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Principal Investigator: Ralph Schutz, MD Quintiles, Inc.
Study Director: Colleen Jensen AstraZeneca
Study Chair: Brendan Smyth AstraZeneca

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Responsible Party: MSD, AstraZeneca
ClinicalTrials.gov Identifier: NCT01124760    
Other Study ID Numbers: D2690C00008
First Posted: May 17, 2010    Key Record Dates
Last Update Posted: August 3, 2010
Last Verified: August 2010
Keywords provided by AstraZeneca:
open label
2-consecutive-group
2-period
1-sequence crossover study
Additional relevant MeSH terms:
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Ketoconazole
Diltiazem
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inhibitors
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Calcium-Regulating Hormones and Agents
Vasodilator Agents