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

Sponsor

ViiV Healthcare (Industry)

Overall Status

Completed

CT.gov ID

NCT02480881

Collaborator

GlaxoSmithKline (Industry)

Enrollment

Locations

Arm

6.2

Actual Duration (Months)

Patients Per Site

2.1

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Infection, Human Immunodeficiency Virus	Drug: BMS-663068 Drug: Oral Contraceptive Drug: Loestrin 1.5/30	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

26 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Effect of BMS-663068 on the Pharmacokinetics of a Combined Oral Contraceptive Containing Ethinyl Estradiol and Norethindrone Acetate in Healthy Female Subjects

Actual Study Start Date :

Jul 7, 2015

Actual Primary Completion Date :

Jan 11, 2016

Actual Study Completion Date :

Jan 11, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Single Sequence A, B, C, and D 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.	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) Other Names: Junel Microgestin 1.5/30

Arm

Intervention/Treatment

Experimental: Single Sequence A, B, C, and D

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.

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)

Other Names:

Junel

Microgestin 1.5/30

Outcome Measures

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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
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 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 Clinical Laboratory Evaluations. [From Day 1 (Treatment A/Cycle 1) to Day 22 (Treament D/Cycle 4)]
clinical chemistry, hematology, and urinalysis.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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