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

Study Overview
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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).

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

Conditions
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Infection, Human Immunodeficiency Virus

Intervention / Treatment
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* Drug: BMS-663068
* Drug: Oral Contraceptive
* Drug: Loestrin 1.5/30


Participation Criteria
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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 Exclusion Criteria: Any significant acute or chronic medical illness Other protocol defined exclusion criteria could apply.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single Sequence A, B, C, and D<br>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<br>* Investigational product<br>Drug: Oral Contraceptive<br>* Subject's existing combination OC tablet containing EE and progestin<br>Drug: Loestrin 1.5/30<br>* OC containing EE and norethindrone acetate (NEA)<br>* Other names: Microgestin 1.5/30;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic parameter Cmax | Pharmacokinetic parameter includes: maximal observed concentration (Cmax) for EE and NE. | 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. | From Day 21 of Treatment C/Cycle 3 to Day 21 of Treatment D/Cycle 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Safety as Measured by Adverse Event Monitoring. | Adverse event monitoring | From Day 1 (Treatment A/Cycle 1) to Day 22 (Treament D/Cycle 4) | 
| Clinical Safety as Measured by the Collection of Vital Signs. | Vital signs assessments | From Day 1 (Treatment A/Cycle 1) to Day 22 (Treament D/Cycle 4) | 
| Clinical Safety as Measured by the Collection of Electrocardiograms (ECGs). | 12-lead ECGs | From Day 1 (Treatment A/Cycle 1) to Day 22 (Treament D/Cycle 4) | 
| Clinical Safety as measured by Physical Examination. | Physical examinations | From Day 1 (Treatment A/Cycle 1) to Day 22 (Treament D/Cycle 4) | 
| Clinical Safety as Measured by Clinical Laboratory Evaluations. | clinical chemistry, hematology, and urinalysis. | From Day 1 (Treatment A/Cycle 1) to Day 22 (Treament D/Cycle 4) | 
| Pharmacokinetic Parameter | Pharmacokinetic parameter: -time of maximum observed concentration (Tmax) for EE and NE. | From Day 21 of Treatment C/Cycle 3 to Day 21 of Treatment D/Cycle 4 |