Drug Interaction Oral Contraceptive Pill (OCP)
Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Completed
CT.gov ID
NCT01063023
Collaborator
(none)
20
1
3
5
4
Study Details
Study Description
Brief Summary
To assess the effects of BMS-650032 on Pharmacokinetics (PK) of ethinyl estradiol (EE) and norelgestromin (NGMN) in healthy female subjects
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
20 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Official Title:
Effect of BMS-650032 on the Pharmacokinetics of a Combined Oral Contraceptive Containing Ethinyl Estradiol and Norgestimate (Ortho Tri- Cyclen (R)) in Healthy Female Subjects
Study Start Date
:
Jan 1, 2010
Actual Primary Completion Date
:
Jun 1, 2010
Actual Study Completion Date
:
Jun 1, 2010
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Arm A - Ortho Tri-Cyclen® 1 to 28 days |
Drug: Ortho Tri-Cyclen®
Tablets, Oral, 1 Tablet, once daily
|
| Active Comparator: Arm B - Ortho Tri-Cyclen® 29 to 56 days |
Drug: Ortho Tri-Cyclen®
Tablets, Oral, 1 Tablet, once daily
|
| Active Comparator: Arm C - Ortho Tri-Cyclen® + BMS-650032 Ortho Tri-Cyclen®: 57 to 77 days BMS-650032: 68 to 77 days |
Drug: Ortho Tri-Cyclen®
Tablets, Oral, 1 Tablet, once daily
Drug: BMS-650032
Tablets, Oral, 600 mg, BID
|
Outcome Measures
Primary Outcome Measures
- Pharmacokinetics parameters for ethinyl estradiol (EE), norelgestromin (NGMN) and norgestrel (NG), AUC (TAU) [24 hours of dosing]
Secondary Outcome Measures
- To assess the safety and tolerability of investigational drug and Ortho Tri-Cyclen® when administered [Safety will be assessed through day 78]
- To characterize the PK of norgestrel when Ortho Tri-Cylen® is administered alone and in combination [PK assessments will be done on Day 49, 50, 77 and 78]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 40 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
- Healthy Females, 18-40 years, BMI 18 - 32kg/m². Must use an acceptable method of contraception to avoid pregnancy throughout the study and 8 weeks after last dose of study drug
Exclusion Criteria:
-
Abnormal pap smear within 1 year prior to day 1
-
Any significant or chronic uncontrolled medical illness
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Pra International | Lenexa | Kansas | United States | 66219 |
Sponsors and Collaborators
- Bristol-Myers Squibb
Investigators
- Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT01063023
Other Study ID Numbers:
- AI447-019
First Posted:
Feb 5, 2010
Last Update Posted:
Jan 25, 2011
Last Verified:
Jun 1, 2010
Additional relevant MeSH terms: