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

ViiV Healthcare26 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Infection, Human Immunodeficiency Virus

Interventions

BMS-663068DRUG

Investigational product

Oral ContraceptiveDRUG

Subject's existing combination OC tablet containing EE and progestin

Loestrin 1.5/30DRUG

OC containing EE and norethindrone acetate (NEA)

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (2)

GSK Investigational Site

Miami, Florida, United States

GSK Investigational Site

San Antonio, Texas, United States

Outcomes

Primary Outcomes

Pharmacokinetic parameter Cmax

Pharmacokinetic parameter includes: maximal observed concentration (Cmax) for EE and NE.

Time frame: From Day 21 of Treatment C/Cycle 3 to Day 21 of Treatment D/Cycle 4

Pharmacokinetic parameter AUC TAU

Pharmacokinetic parameter includes: area under the concentration-time curve in one dosing interval (AUC(TAU)) for EE and NE.

Time frame: From Day 21 of Treatment C/Cycle 3 to Day 21 of Treatment D/Cycle 4