Trials / Completed
CompletedNCT02480881
A Drug-drug Interaction Study Between BMS-663068 and Oral Contraceptives in Healthy Female Volunteers (DDI)
Effect of BMS-663068 on the Pharmacokinetics of a Combined Oral Contraceptive Containing Ethinyl Estradiol and Norethindrone Acetate in Healthy Female Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 26 (actual)
- Sponsor
- ViiV Healthcare · Industry
- Sex
- Female
- Age
- 18 Years – 40 Years
- Healthy volunteers
- Accepted
Summary
This is an open-label, single sequence, 4-cycle, 4-treatment, drug-drug interaction (DDI) study in healthy female subjects on oral contraceptives (OC). There is no formal research hypothesis to be statistically tested. It is expected that coadministration of BMS-663068 with OC will not affect the pharmacokinetics (PK) of either ethinyl estradiol (EE) or norethindrone (NE).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | BMS-663068 | Investigational product |
| DRUG | Oral Contraceptive | Subject's existing combination OC tablet containing EE and progestin |
| DRUG | Loestrin 1.5/30 | OC containing EE and norethindrone acetate (NEA) |
Timeline
- Start date
- 2015-07-07
- Primary completion
- 2016-01-11
- Completion
- 2016-01-11
- First posted
- 2015-06-25
- Last updated
- 2017-07-27
Locations
2 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02480881. Inclusion in this directory is not an endorsement.