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

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).

Full Title of Study: “Effect of BMS-663068 on the Pharmacokinetics of a Combined Oral Contraceptive Containing Ethinyl Estradiol and Norethindrone Acetate in Healthy Female Subjects”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 11, 2016

Interventions

  • Drug: BMS-663068
    • Investigational product
  • Drug: Oral Contraceptive
    • Subject’s existing combination OC tablet containing EE and progestin
  • Drug: Loestrin 1.5/30
    • OC containing EE and norethindrone acetate (NEA)

Arms, Groups and Cohorts

  • Experimental: 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.

Clinical Trial Outcome Measures

Primary Measures

  • Pharmacokinetic parameter Cmax
    • Time Frame: 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
    • Time Frame: 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 Measures

  • Clinical Safety as Measured by Adverse Event Monitoring.
    • Time Frame: From Day 1 (Treatment A/Cycle 1) to Day 22 (Treament D/Cycle 4)
    • Adverse event monitoring
  • Clinical Safety as Measured by the Collection of Vital Signs.
    • Time Frame: From Day 1 (Treatment A/Cycle 1) to Day 22 (Treament D/Cycle 4)
    • Vital signs assessments
  • Clinical Safety as Measured by the Collection of Electrocardiograms (ECGs).
    • Time Frame: From Day 1 (Treatment A/Cycle 1) to Day 22 (Treament D/Cycle 4)
    • 12-lead ECGs
  • Clinical Safety as measured by Physical Examination.
    • Time Frame: From Day 1 (Treatment A/Cycle 1) to Day 22 (Treament D/Cycle 4)
    • Physical examinations
  • Clinical Safety as Measured by Clinical Laboratory Evaluations.
    • Time Frame: From Day 1 (Treatment A/Cycle 1) to Day 22 (Treament D/Cycle 4)
    • clinical chemistry, hematology, and urinalysis.
  • Pharmacokinetic Parameter
    • Time Frame: 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.

Participating in This Clinical Trial

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.

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 40 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • ViiV Healthcare
  • Collaborator
    • GlaxoSmithKline
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • GSK Clinical Trials, Study Director, ViiV Healthcare

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