NCT02480881

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jul 2015

Shorter than P25 for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 18, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 25, 2015

Completed
12 days until next milestone

Study Start

First participant enrolled

July 7, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 11, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 11, 2016

Completed
Last Updated

July 27, 2017

Status Verified

July 1, 2017

Enrollment Period

6 months

First QC Date

June 18, 2015

Last Update Submit

July 25, 2017

Conditions

Infection, Human Immunodeficiency Virus

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (6)

  • Clinical Safety as Measured by 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.

    From Day 1 (Treatment A/Cycle 1) to Day 22 (Treament D/Cycle 4)

  • Clinical Safety as Measured by the Collection of Electrocardiograms (ECGs).

    From Day 1 (Treatment A/Cycle 1) to Day 22 (Treament D/Cycle 4)

  • Clinical Safety as measured by Physical Examination.

    From Day 1 (Treatment A/Cycle 1) to Day 22 (Treament D/Cycle 4)

  • Clinical Safety as Measured by Clinical Laboratory Evaluations.

    From Day 1 (Treatment A/Cycle 1) to Day 22 (Treament D/Cycle 4)

  • +1 more secondary outcomes

Study Arms (1)

Single Sequence A, B, C, and D

EXPERIMENTAL

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-663068Drug: Oral ContraceptiveDrug: Loestrin 1.5/30

Interventions

BMS-663068DRUG

Investigational product

Single Sequence A, B, C, and D
Oral ContraceptiveDRUG

Subject's existing combination OC tablet containing EE and progestin

Single Sequence A, B, C, and D
Loestrin 1.5/30DRUG

OC containing EE and norethindrone acetate (NEA)

Also known as: Junel, Microgestin 1.5/30
Single Sequence A, B, C, and D

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Any significant acute or chronic medical illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

GSK Investigational Site

Miami, Florida, 33143, United States

Location

GSK Investigational Site

San Antonio, Texas, 78209, United States

Location

MeSH Terms

Conditions

InfectionsAcquired Immunodeficiency Syndrome

Interventions

fostemsavirContraceptives, Oral

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

Contraceptive Agents, FemaleContraceptive AgentsReproductive Control AgentsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesTherapeutic Uses

Study Officials

  • GSK Clinical Trials

    ViiV Healthcare

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 18, 2015

First Posted

June 25, 2015

Study Start

July 7, 2015

Primary Completion

January 11, 2016

Study Completion

January 11, 2016

Last Updated

July 27, 2017

Record last verified: 2017-07

Locations

US(2)