Clinical trial NCT02480881: A Drug-drug Interaction Study Between BMS-663068 and Oral Contraceptives in Healthy Female Volunteers (DDI)
Official title: Effect of BMS-663068 on the Pharmacokinetics of a Combined Oral Contraceptive Containing Ethinyl Estradiol and Norethindrone Acetate in Healthy Female Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Infection, Human Immunodeficiency Virus
Lead sponsor: ViiV Healthcare
Sponsor class: INDUSTRY
Collaborators: name: GlaxoSmithKline
First posted: 2015-06-25
Enrollment: 26
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Pharmacokinetic parameter Cmax
timeFrame: From Day 21 of Treatment C/Cycle 3 to Day 21 of Treatment D/Cycle 4
measure: Pharmacokinetic parameter AUC TAU
timeFrame: From Day 21 of Treatment C/Cycle 3 to Day 21 of Treatment D/Cycle 4
Secondary outcomes:
measure: Clinical Safety as Measured by Adverse Event Monitoring.
timeFrame: From Day 1 (Treatment A/Cycle 1) to Day 22 (Treament D/Cycle 4)
measure: Clinical Safety as Measured by the Collection of Vital Signs.
timeFrame: From Day 1 (Treatment A/Cycle 1) to Day 22 (Treament D/Cycle 4)
measure: Clinical Safety as Measured by the Collection of Electrocardiograms (ECGs).
timeFrame: From Day 1 (Treatment A/Cycle 1) to Day 22 (Treament D/Cycle 4)
measure: Clinical Safety as measured by Physical Examination.
timeFrame: From Day 1 (Treatment A/Cycle 1) to Day 22 (Treament D/Cycle 4)
measure: Clinical Safety as Measured by Clinical Laboratory Evaluations.
timeFrame: From Day 1 (Treatment A/Cycle 1) to Day 22 (Treament D/Cycle 4)
measure: Pharmacokinetic Parameter
timeFrame: From Day 21 of Treatment C/Cycle 3 to Day 21 of Treatment D/Cycle 4
Other outcomes:
Locations:
city: Miami
country: United States
facility: GSK Investigational Site
state: Florida
city: San Antonio
country: United States
facility: GSK Investigational Site
state: Texas
Study officials:
affiliation: ViiV Healthcare
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: