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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-07

Study Completion Date

2016-01-11

Brief Summary

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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).

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Detailed Description

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Conditions

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Infection, Human Immunodeficiency Virus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

BMS-663068

Intervention Type DRUG

Investigational product

Oral Contraceptive

Intervention Type DRUG

Subject's existing combination OC tablet containing EE and progestin

Loestrin 1.5/30

Intervention Type DRUG

OC containing EE and norethindrone acetate (NEA)

Interventions

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BMS-663068

Investigational product

Intervention Type DRUG

Oral Contraceptive

Subject's existing combination OC tablet containing EE and progestin

Intervention Type DRUG

Loestrin 1.5/30

OC containing EE and norethindrone acetate (NEA)

Intervention Type DRUG

Other Intervention Names

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Junel Microgestin 1.5/30

Eligibility Criteria

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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