Overview

Drug-Drug Interaction Study Between Colchicine and Diltiazem ER

Status:
Completed
Trial end date:
2008-08-01
Target enrollment:
0
Participant gender:
All
Summary
Colchicine is a substrate for both cytochrome P450 3A4 (CYP3A4) and P-glycoprotein (P-gp). Extended-release diltiazem (diltiazem ER) is a potent inhibitor of both CYP3A4 and P-gp. This study will evaluate the effect of multiple doses of diltiazem ER on the pharmacokinetic profile of a single 0.6 mg dose of colchicine. A secondary objective is to evaluate the safety and tolerability of this regimen in healthy volunteers. All study subjects will be monitored for adverse events throughout the study period.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Mutual Pharmaceutical Company, Inc.
Treatments:
Colchicine
Diltiazem
Criteria
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.