A Drug-drug Interaction Study Between BMS-663068 and Oral Contraceptives in Healthy Female Volunteers (DDI)
- Conditions
- Infection, Human Immunodeficiency Virus
- Interventions
- Registration Number
- NCT02480881
- Lead Sponsor
- ViiV Healthcare
- Brief 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 26
- 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
- Any significant acute or chronic medical illness
Other protocol defined exclusion criteria could apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Single Sequence A, B, C, and D BMS-663068 Treatment A/Cycle 1: OC containing EE and progestin taken by mouth. Treatment B/Cycle 2: OC containing EE and progestin taken by mouth. Treatment C/Cycle 3: Loestrin 1.5/30 taken by mouth. Treatment D/Cycle 4: Loestrin 1.5/30 (alone) and Loestrin 1.5/30 with BMS-663068 taken by mouth. Single Sequence A, B, C, and D Oral Contraceptive Treatment A/Cycle 1: OC containing EE and progestin taken by mouth. Treatment B/Cycle 2: OC containing EE and progestin taken by mouth. Treatment C/Cycle 3: Loestrin 1.5/30 taken by mouth. Treatment D/Cycle 4: Loestrin 1.5/30 (alone) and Loestrin 1.5/30 with BMS-663068 taken by mouth. Single Sequence A, B, C, and D Loestrin 1.5/30 Treatment A/Cycle 1: OC containing EE and progestin taken by mouth. Treatment B/Cycle 2: OC containing EE and progestin taken by mouth. Treatment C/Cycle 3: Loestrin 1.5/30 taken by mouth. Treatment D/Cycle 4: Loestrin 1.5/30 (alone) and Loestrin 1.5/30 with BMS-663068 taken by mouth.
- Primary Outcome Measures
Name Time Method Pharmacokinetic parameter AUC TAU From Day 21 of Treatment C/Cycle 3 to Day 21 of Treatment D/Cycle 4 Pharmacokinetic parameter includes:
area under the concentration-time curve in one dosing interval (AUC(TAU)) for EE and NE.Pharmacokinetic parameter Cmax From Day 21 of Treatment C/Cycle 3 to Day 21 of Treatment D/Cycle 4 Pharmacokinetic parameter includes:
maximal observed concentration (Cmax) for EE and NE.
- Secondary Outcome Measures
Name Time Method Clinical Safety as Measured by the Collection of Electrocardiograms (ECGs). From Day 1 (Treatment A/Cycle 1) to Day 22 (Treament D/Cycle 4) 12-lead ECGs
Clinical Safety as measured by Physical Examination. From Day 1 (Treatment A/Cycle 1) to Day 22 (Treament D/Cycle 4) Physical examinations
Clinical Safety as Measured by Adverse Event Monitoring. From Day 1 (Treatment A/Cycle 1) to Day 22 (Treament D/Cycle 4) Adverse event monitoring
Pharmacokinetic Parameter From Day 21 of Treatment C/Cycle 3 to Day 21 of Treatment D/Cycle 4 Pharmacokinetic parameter:
-time of maximum observed concentration (Tmax) for EE and NE.Clinical Safety as Measured by the Collection of Vital Signs. From Day 1 (Treatment A/Cycle 1) to Day 22 (Treament D/Cycle 4) Vital signs assessments
Clinical Safety as Measured by Clinical Laboratory Evaluations. From Day 1 (Treatment A/Cycle 1) to Day 22 (Treament D/Cycle 4) clinical chemistry, hematology, and urinalysis.
Trial Locations
- Locations (1)
GSK Investigational Site
🇺🇸San Antonio, Texas, United States