A Drug-drug Interaction Study Between BMS-663068 and Oral Contraceptives in Healthy Female Volunteers (DDI)

Completed · Phase 1

Conditions studied: Infection, Human Immunodeficiency Virus

In brief

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).

Key facts

Study ID

NCT02480881

Run by

ViiV Healthcare

People needed

26

Starts

2015-07-07

Expected to finish

2016-01-11

Last updated by the study team

2017-07-27

Who can join

Age: 18 and older, up to 40. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• Any significant acute or chronic medical illness
• Other protocol defined exclusion criteria could apply.

Where it is running

• GSK Investigational Site — Miami, Florida, United States
• GSK Investigational Site — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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