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Completed

NCT Number: NCT02480881

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

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).

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Key information

Conditions

Infection, Human Immunodeficiency Virus Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

GSK Investigational Site, Miami, Florida, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BMS-663068

Drug

Investigational product

Oral contraceptive

Drug

Subject's existing combination OC tablet containing EE and progestin

Loestrin 1.5/30

Drug

OC containing EE and norethindrone acetate (NEA)

Other names: Junel, Microgestin 1.5/30

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

ViiV Healthcare

Industry

Collaborators

  • GlaxoSmithKline

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jun 25, 2015
Registry last updated
Jul 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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