A Pharmacokinetic Study of Colchicine With an Oral Contraceptive

13:19 EDT 23rd August 2014 | BioPortfolio

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.

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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Conditions

Pharmacokinetics

Intervention

Norethindrone/Ethinyl Estradiol, Colchicine, Placebo (for Colchicine)

Location

PRACS Institute, Ltd. - Cetero Research
Fargo
North Dakota
United States
58104

Status

Completed

Source

Mutual Pharmaceutical Company, Inc.

Results (where available)

View Results

Links

Clinical Trials [466 Associated Clinical Trials listed on BioPortfolio]

Drug-Drug Interaction Study of Colchicine and Clarithromycin

Clarithromycin is a potent inhibitor of the activity of cytochrome P450 (CYP) 3A4 and P-glycoprotein (P-gp). CYP 3A4 plays a role in the metabolism of colchicine and P-gp is responsible f...

Pharmacokinetic Study With Colchicine in Healthy Volunteers

This open label, single group, sequential dose study will compare the single dose pharmacokinetics of colchicine 0.6 mg given orally to colchicine pharmacokinetics after 10 days of a stan...

Bioequivalence Study of Colchicine Tablets

This randomized, single dose, three-way crossover study will evaluate the bioequivalence of two formulations of colchicine, the test product (colchicine 0.6mg Mutual) and a marketed combin...

Drug-Drug Interaction Between Colchicine and Ritonavir

Ritonavir is a potent inhibitor of CYP3A4, one of the enzymes responsible for the metabolism of colchicine. This study will evaluate the effect of multiple doses of ritonavir on the pharm...

Drug-Drug Interaction Study Between Colchicine and Ketoconazole

Ketoconazole is a potent inhibitor of the cytochrome P450 (CYP) 3A4 enzyme system, one of the enzyme systems responsible for the metabolism of colchicine. This study will evaluate the eff...

PubMed Articles [1957 Associated PubMed Articles listed on BioPortfolio]

Colchicine for the prevention of pericarditis: what we know and what we do not know in 2014 - systematic review and meta-analysis.

The purpose of this study was to investigate and summarize available evidence on the efficacy and safety of colchicine for pericarditis prevention. Disease recurrence is the major and most common comp...

Colchicine in Behcet Syndrome: A Longterm Survey of Patients in a Controlled Trial.

To test the hypothesis that colchicine use during early disease decreases immunosuppressive use in Behçet syndrome (BS) in the long term.

Low-Dose Levonorgestrel and Ethinyl Estradiol Patch and Pill: A Randomized Controlled Trial.

To compare a new low-dose levonorgestrel and ethinyl estradiol contraceptive patch (Patch) with a combination oral contraceptive (Pill; 100 micrograms levonorgestrel, 20 micrograms ethinyl estradiol)...

Increase induced by colchicine in the incidence of somatic crossing over in Glycine max.

The frequency of somatic crossing over in Glycine max has been significantly increased by soaking the dry seeds in aqueous solutions of 0.0025, 0.005 and 0.01% colchicine. This increase was quite cons...

Evaluating appropriate use of prophylactic colchicine for gout flare prevention.

Objective: ACR and EULAR guidelines recommend colchicine to prevent gout flares in patients initiating and increasing uric acid lowering therapy until serum uric acid is maintained at ≤ 6 mg/dL. We...

Medical and Biotech [MESH] Definitions

Three, alpha, beta, and gamma isomers of ultraviolet degradation products of colchicine that lack many of the physiological actions of the parent; used as experimental control for colchicine actions.

ETHINYL ESTRADIOL and NORGESTREL given in fixed proportions. It has proved to be an effective contraceptive (CONTRACEPTIVES, ORAL, COMBINED).

A semisynthetic alkylated ESTRADIOL with a 17-alpha-ethinyl substitution. It has high estrogenic potency when administered orally, and is often used as the estrogenic component in ORAL CONTRACEPTIVES.

A major alkaloid from Colchicum autumnale L. and found also in other Colchicum species. Its primary therapeutic use is in the treatment of gout, but it has been used also in the therapy of familial Mediterranean fever (PERIODIC DISEASE).

A microtubule subunit protein found in large quantities in mammalian brain. It has also been isolated from SPERM FLAGELLUM; CILIA; and other sources. Structurally, the protein is a dimer with a molecular weight of approximately 120,000 and a sedimentation coefficient of 5.8S. It binds to COLCHICINE; VINCRISTINE; and VINBLASTINE.

More From BioPortfolio on "A Pharmacokinetic Study of Colchicine With an Oral Contraceptive"

Search BioPortfolio:
Advertisement

Relevant Topics

Pediatrics
Latest News Clinical Trials Research Drugs Reports Corporate
Pediatrics is the general medicine of childhood. Because of the developmental processes (psychological and physical) of childhood, the involvement of parents, and the social management of conditions at home and at school, pediatrics is a specialty. With...

Blood
Latest News Clinical Trials Research Drugs Reports Corporate
Blood is a specialized bodily fluid that delivers necessary substances to the body's cells (in animals) – such as nutrients and oxygen – and transports waste products away from those same cells.  In vertebrates, it is composed of blo...

Advertisement