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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00983372 |
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Date of registration:
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13/08/2009 |
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Primary sponsor: |
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Public title:
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Drug-Drug Interaction Study Between Colchicine and Diltiazem ER
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Scientific title:
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A One-Directional, Open-Label Drug Interaction Study to Investigate the Effects of Multiple-Dose Diltiazem ER on Single-Dose Pharmacokinetics of Colchicine in Healthy Volunteers |
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Date of first enrolment:
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August 2008 |
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Target sample size:
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24 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00983372 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
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Countries of recruitment
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United States
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Contacts
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Name:
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Anthony R Godfrey, PharmD |
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Address:
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Telephone:
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Email:
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Affiliation:
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PRACS - Cetero |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Healthy adults 18-45 years of age, non-smoking and non-pregnant (post-menopausal,
surgically sterile or using effective contraceptive measures) with a body mass index
(BMI) greater than or equal to 18 and less than or equal to 32, inclusive.
Exclusion Criteria:
- Recent participation (within 28 days) in other research studies
- Recent significant blood donation or plasma donation
- Pregnant or lactating
- Test positive at screening for human immunodeficiency virus (HIV), hepatitis B
surface antigen (HbsAg), or hepatitis C virus (HCV)
- Recent (2-year) history or evidence of alcoholism or drug abuse
- History or presence of significant cardiovascular, pulmonary, hepatic, gallbladder or
biliary tract, renal, hematologic, gastrointestinal, endocrine, immunologic,
dermatologic, neurologic, or psychiatric disease
- Subjects who have used any drugs or substances known to inhibit or induce cytochrome
(CYP) P450 enzymes and/or P-glycoprotein (P-gp) within 28 days prior to the first
dose and throughout the study
- Drug allergies to colchicine or diltiazem.
Age minimum:
18 Years
Age maximum:
45 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Healthy; Adult; Volunteer; Colchicine; Pharmacokinetics; Diltiazem; Cytochrome p450 3A4; P-glycoprotein
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Intervention(s)
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Drug: Colchicine
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Drug: Diltiazem ER
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Primary Outcome(s)
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Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-8)]
[Time Frame: serial pharmacokinetic blood samples drawn immediately prior to dosing on Days 1 and 21, and then 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, and 96 hours after dose administration]
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Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)]
[Time Frame: serial pharmacokinetic blood samples drawn immediately prior to dosing on Days 1 and 21, and then 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, and 96 hours after dose administration]
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Maximum Plasma Concentration (Cmax)
[Time Frame: serial pharmacokinetic blood samples drawn immediately prior to dosing on Days 1 and 21, and then 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, and 96 hours after dose administration]
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Secondary ID(s)
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MPC-***********
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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