Back to resultsA Drug-drug Interaction Study Between BMS-663068 and Oral Contraceptives in Healthy Female Volunteers (DDI)
Primary Purpose
Infection, Human Immunodeficiency Virus
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
BMS-663068
Oral Contraceptive
Loestrin 1.5/30
Sponsored by
About this trial
This is an interventional treatment trial for Infection, Human Immunodeficiency Virus
Eligibility 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.
Sites / Locations
- GSK Investigational Site
- GSK Investigational Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Single Sequence A, B, C, and D
Arm Description
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.
Outcomes
Primary Outcome Measures
Pharmacokinetic parameter Cmax
Pharmacokinetic parameter includes:
maximal observed concentration (Cmax) for EE and NE.
Pharmacokinetic parameter AUC TAU
Pharmacokinetic parameter includes:
area under the concentration-time curve in one dosing interval (AUC(TAU)) for EE and NE.
Secondary Outcome Measures
Clinical Safety as Measured by Adverse Event Monitoring.
Adverse event monitoring
Clinical Safety as Measured by the Collection of Vital Signs.
Vital signs assessments
Clinical Safety as Measured by the Collection of Electrocardiograms (ECGs).
12-lead ECGs
Clinical Safety as measured by Physical Examination.
Physical examinations
Clinical Safety as Measured by Clinical Laboratory Evaluations.
clinical chemistry, hematology, and urinalysis.
Pharmacokinetic Parameter
Pharmacokinetic parameter:
-time of maximum observed concentration (Tmax) for EE and NE.
Full Information
NCT ID
NCT02480881
First Posted
June 18, 2015
Last Updated
July 25, 2017
Sponsor
ViiV Healthcare
Collaborators
GlaxoSmithKline
1. Study Identification
Unique Protocol Identification Number
NCT02480881
Brief Title
A Drug-drug Interaction Study Between BMS-663068 and Oral Contraceptives in Healthy Female Volunteers (DDI)
Official Title
Effect of BMS-663068 on the Pharmacokinetics of a Combined Oral Contraceptive Containing Ethinyl Estradiol and Norethindrone Acetate in Healthy Female Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
July 7, 2015 (Actual)
Primary Completion Date
January 11, 2016 (Actual)
Study Completion Date
January 11, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ViiV Healthcare
Collaborators
GlaxoSmithKline
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infection, Human Immunodeficiency Virus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single Sequence A, B, C, and D
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
BMS-663068
Intervention Description
Investigational product
Intervention Type
Drug
Intervention Name(s)
Oral Contraceptive
Intervention Description
Subject's existing combination OC tablet containing EE and progestin
Intervention Type
Drug
Intervention Name(s)
Loestrin 1.5/30
Other Intervention Name(s)
Junel, Microgestin 1.5/30
Intervention Description
OC containing EE and norethindrone acetate (NEA)
Primary Outcome Measure Information:
Title
Pharmacokinetic parameter Cmax
Description
Pharmacokinetic parameter includes:
maximal observed concentration (Cmax) for EE and NE.
Time Frame
From Day 21 of Treatment C/Cycle 3 to Day 21 of Treatment D/Cycle 4
Title
Pharmacokinetic parameter AUC TAU
Description
Pharmacokinetic parameter includes:
area under the concentration-time curve in one dosing interval (AUC(TAU)) for EE and NE.
Time Frame
From Day 21 of Treatment C/Cycle 3 to Day 21 of Treatment D/Cycle 4
Secondary Outcome Measure Information:
Title
Clinical Safety as Measured by Adverse Event Monitoring.
Description
Adverse event monitoring
Time Frame
From Day 1 (Treatment A/Cycle 1) to Day 22 (Treament D/Cycle 4)
Title
Clinical Safety as Measured by the Collection of Vital Signs.
Description
Vital signs assessments
Time Frame
From Day 1 (Treatment A/Cycle 1) to Day 22 (Treament D/Cycle 4)
Title
Clinical Safety as Measured by the Collection of Electrocardiograms (ECGs).
Description
12-lead ECGs
Time Frame
From Day 1 (Treatment A/Cycle 1) to Day 22 (Treament D/Cycle 4)
Title
Clinical Safety as measured by Physical Examination.
Description
Physical examinations
Time Frame
From Day 1 (Treatment A/Cycle 1) to Day 22 (Treament D/Cycle 4)
Title
Clinical Safety as Measured by Clinical Laboratory Evaluations.
Description
clinical chemistry, hematology, and urinalysis.
Time Frame
From Day 1 (Treatment A/Cycle 1) to Day 22 (Treament D/Cycle 4)
Title
Pharmacokinetic Parameter
Description
Pharmacokinetic parameter:
-time of maximum observed concentration (Tmax) for EE and NE.
Time Frame
From Day 21 of Treatment C/Cycle 3 to Day 21 of Treatment D/Cycle 4
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
ViiV Healthcare
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
GSK Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78209
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Drug-drug Interaction Study Between BMS-663068 and Oral Contraceptives in Healthy Female Volunteers (DDI)
We'll reach out to this number within 24 hrs