A Pharmacokinetic Study of Colchicine With an Oral Contraceptive
Information source: Mutual Pharmaceutical Company, Inc.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pharmacokinetics
Intervention: Norethindrone/Ethinyl Estradiol (Drug); Colchicine (Drug); Placebo (for Colchicine) (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Mutual Pharmaceutical Company, Inc.
Summary
This study will evaluate the effect, if any, of twice daily dosing of colchicine 0. 6 mg at
steady state on the steady state pharmacokinetic profile of ethinyl estradiol and
norethindrone (Ortho-Novum 1/35). It will also evaluate the effects, if any, of steady
state ethinyl estradiol and norethindrone on colchicine at steady state. Finally, this
study will assess the safety and tolerability of concurrent use of colchicine and an
estrogen/progesterone-containing oral contraceptive.
Clinical Details
Official title: A Pharmacokinetic Study to Evaluate the Effect of Colchicine on the Pharmacokinetic Profile of an Oral Contraceptive Containing Ethinyl Estradiol and Norethindrone in Healthy Women
Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science
Primary outcome: Maximum Plasma Concentration of Norethindrone With Colchicine at Steady State (Cmax, ss)Maximum Plasma Concentration of Norethindrone With Placebo at Steady State (Cmax, ss) Maximum Plasma Concentration of Ethinyl Estradiol With Colchicine at Steady State (Cmax, ss) Maximum Plasma Concentration of Ethinyl Estradiol With Placebo at Steady State (Cmax, ss) Maximum Plasma Concentration of Colchicine With Norethindrone/Ethinyl Estradiol at Steady State (Cmax, ss) Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)] for Norethindrone With Colchicine Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)] for Norethindrone With Placebo Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)] Ethinyl Estradiol With Colchicine Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)] for Ethinyl Estradiol With Placebo Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)] for Colchicine With Norethindrone/Ethinyl Estradiol
Detailed description:
This study will evaluate the effect, if any, of twice daily dosing of colchicine 0. 6 mg at
steady state on the steady state pharmacokinetic profile of ethinyl estradiol and
norethindrone (Ortho-Novum 1/35). It will also evaluate the effects, if any, of steady
state ethinyl estradiol and norethindrone on colchicine at steady state. Finally, this
study will assess the safety and tolerability of concurrent use of colchicine and an
estrogen/progesterone-containing oral contraceptive. Following an optional single cycle
run-in period in which subjects taking other oral contraceptives are switched to Ortho-Novum
1/35, 30 healthy adult female volunteers of child bearing age (18-45 years old) will be
randomized in a double blind crossover fashion to receive each of two ethinyl estradiol and
norethindrone dosing regimens in sequence. During each of the two dosing periods, subjects
will receive one ethinyl estradiol and norethindrone tablet on the mornings of Days 1-7 of
their cycles. On days 8-21, subjects will receive twice daily doses of either colchicine
(0. 6 mg capsule twice daily with breakfast and dinner) or the placebo (one capsule twice
daily with breakfast and dinner), according to their randomization schedule, along with one
ethinyl estradiol and norethindrone tablet. Subjects will receive the alternate dosing
regimen in Cycle 2. Blood samples will be drawn at times sufficient to determine the steady
state pharmacokinetics of ethinyl estradiol and norethindrone with and without steady state
colchicine. In addition, during the cycle in which active colchicine is given, the effect
of steady state ethinyl estradiol and norethindrone on steady state colchicine will be
evaluated. Subjects will be monitored for adverse effects throughout the study via query
and spontaneous reporting. Additionally baseline 12 lead EKG and vital signs will be
compared to those obtained at time points throughout the study period.
Eligibility
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- Healthy, non-smoking female volunteers of childbearing potential aged 18 to 45 years
weighing at least 55 kg and within 15% of ideal body weight who are taking oral
contraceptives on the advice of their personal health care provider and willing to
switch to Ortho-Novum 1/35
- Subjects should be either sexually inactive or using a double barrier method of
contraception for 14 days before the first dose of study drug and throughout the
study
Exclusion Criteria:
- Pregnant or lactating
- Recent (2-year) history or evidence of alcoholism or drug abuse
- Test positive at screening for human immunodeficiency virus (HIV), hepatitis B
surface antigen (HbsAg), or hepatitis C antibody (HCV)
- History or presence of significant cardiovascular, pulmonary, hepatic, renal,
hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological,
or psychiatric disease
- Hemoglobin < 12 g/dL
- Use of any drugs or substances known to inhibit or induce cytochrome (CYP) P450
enzymes and/or P-gp within 30 days prior to the first dose of Ortho-NovumĀ® 1/35 or
expected to require such use
Locations and Contacts
PRACS Institute, Ltd. - Cetero Research, Fargo, North Dakota 58104, United States
Additional Information
Recalls, Market Withdrawals and Safety Alerts
Starting date: August 2007
Last updated: December 30, 2009
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