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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02480881

Enrollment

Registered

2015-06-25

Start date

2015-07-07

Completion date

2016-01-11

Last updated

2017-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infection, Human Immunodeficiency Virus

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).

Interventions

DRUGLoestrin 1.5/30

OC containing EE and norethindrone acetate (NEA)

DRUGBMS-663068

Investigational product

DRUGOral Contraceptive

Subject's existing combination OC tablet containing EE and progestin

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 40 Years

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

Exclusion criteria

* Any significant acute or chronic medical illness Other protocol defined

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026