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

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).

Study Overview

• Status: Completed
• Conditions: Infection, Human Immunodeficiency Virus
• Intervention / Treatment: Drug: BMS-663068; Drug: Oral Contraceptive; Drug: Loestrin 1.5/30

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33143
      • GSK Investigational Site
  • Texas
    • San Antonio, Texas, United States, 78209
      • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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); Other Names: Junel; Microgestin 1.5/30

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: ViiV Healthcare
• Collaborators: GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start (Actual): July 7, 2015
• Primary Completion (Actual): January 11, 2016
• Study Completion (Actual): January 11, 2016

Study Registration Dates

• First Submitted: June 18, 2015
• First Submitted That Met QC Criteria: June 22, 2015
• First Posted (Estimate): June 25, 2015

Study Record Updates

• Last Update Posted (Actual): July 27, 2017
• Last Update Submitted That Met QC Criteria: July 25, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases; HIV Infections; Acquired Immunodeficiency Syndrome; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Anti-HIV Agents; Anti-Retroviral Agents; Contraceptive Agents, Hormonal; Reproductive Control Agents; Contraceptives, Oral, Combined; Contraceptive Agents, Female; Contraceptives, Oral, Synthetic; Contraceptives, Oral, Hormonal; HIV Fusion Inhibitors; Viral Fusion Protein Inhibitors; Contraceptives, Oral, Sequential; Contraceptive Agents; Contraceptives, Oral; Norethindrone acetate, ethinyl estradiol, ferrous fumarate drug combination; Fostemsavir
• Other Study ID Numbers: 206279; AI438-019 (Other Identifier: Bristol-Myers Squibb)