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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02480881
Recruitment Status : Completed
First Posted : June 25, 2015
Last Update Posted : July 27, 2017
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
ViiV Healthcare

Study Description
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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).

Condition or disease Intervention/treatment Phase
Infection, Human Immunodeficiency Virus Drug: BMS-663068 Drug: Oral Contraceptive Drug: Loestrin 1.5/30 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of BMS-663068 on the Pharmacokinetics of a Combined Oral Contraceptive Containing Ethinyl Estradiol and Norethindrone Acetate in Healthy Female Subjects
Actual Study Start Date : July 7, 2015
Actual Primary Completion Date : January 11, 2016
Actual Study Completion Date : January 11, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Binovum

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


  2. 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 Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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.

  6. 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.



Eligibility Criteria
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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02480881


Locations
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United States, Florida
GSK Investigational Site
Miami, Florida, United States, 33143
United States, Texas
GSK Investigational Site
San Antonio, Texas, United States, 78209
Sponsors and Collaborators
ViiV Healthcare
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials ViiV Healthcare
More Information
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Responsible Party: ViiV Healthcare
ClinicalTrials.gov Identifier: NCT02480881    
Other Study ID Numbers: 206279
AI438-019 ( Other Identifier: Bristol-Myers Squibb )
First Posted: June 25, 2015    Key Record Dates
Last Update Posted: July 27, 2017
Last Verified: July 2017
Additional relevant MeSH terms:
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Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Immune System Diseases
Blood-Borne Infections
Communicable Diseases
Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Slow Virus Diseases
Genital Diseases
 Urogenital Diseases
Fostemsavir
Contraceptive Agents
Norethindrone acetate, ethinyl estradiol, ferrous fumarate drug combination
Contraceptives, Oral
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptive Agents, Female
Contraceptives, Oral, Combined
Contraceptives, Oral, Hormonal
Contraceptive Agents, Hormonal
Contraceptives, Oral, Sequential
Contraceptives, Oral, Synthetic
Anti-HIV Agents
Anti-Retroviral Agents