A Drug-drug Interaction Study Between BMS-663068 and Oral Contraceptives in Healthy Female Volunteers
| Status: | Completed |
|---|---|
| Conditions: | HIV / AIDS |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - 40 |
| Updated: | 6/3/2016 |
| Start Date: | July 2015 |
| End Date: | January 2016 |
Effect of BMS-663068 on the Pharmacokinetics of a Combined Oral Contraceptive Containing Ethinyl Estradiol and Norethindrone Acetate in Healthy Female Subjects
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).
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).
Inclusion Criteria:
- Healthy female nonsmoking subjects, ages 18 to 40 years, inclusive with a body mass
index of 18.0 kg/m2 to 32.0 kg/m2, inclusive
- Women of child bearing potential with intact ovarian function by medical history and
history of regular menstrual cycles must have been on a stable regimen of combination
oral contraceptives containing EE and progestin (28 day regimen) without evidence of
breakthrough bleeding or spotting for at least 2 consecutive months prior to Day -1
Exclusion Criteria:
- Any significant acute or chronic medical illness
Other protocol defined exclusion criteria could apply.
We found this trial at
2
sites
San Antonio, Texas 78209
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