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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

Tracking Information
First Submitted Date  ICMJE June 18, 2015
First Posted Date  ICMJE June 25, 2015
Last Update Posted Date July 27, 2017
Actual Study Start Date  ICMJE July 7, 2015
Actual Primary Completion Date January 11, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 10, 2017)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 22, 2015)
  • Pharmacokinetic Parameter [ 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.
  • Pharmacokinetic Parameter [ 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 22, 2015)
  • 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
  • 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
  • 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
  • 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
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Drug-drug Interaction Study Between BMS-663068 and Oral Contraceptives in Healthy Female Volunteers (DDI)
Official Title  ICMJE Effect of BMS-663068 on the Pharmacokinetics of a Combined Oral Contraceptive Containing Ethinyl Estradiol and Norethindrone Acetate in Healthy Female Subjects
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Infection, Human Immunodeficiency Virus
Intervention  ICMJE
  • 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
Study Arms  ICMJE 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.
Interventions:
  • Drug: BMS-663068
  • Drug: Oral Contraceptive
  • Drug: Loestrin 1.5/30
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 2, 2016)		 26
Original Estimated Enrollment  ICMJE
 (submitted: June 22, 2015)		 25
Actual Study Completion Date  ICMJE January 11, 2016
Actual Primary Completion Date January 11, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02480881
Other Study ID Numbers  ICMJE 206279
AI438-019 ( Other Identifier: Bristol-Myers Squibb )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party ViiV Healthcare
Original Responsible Party Bristol-Myers Squibb
Current Study Sponsor  ICMJE ViiV Healthcare
Original Study Sponsor  ICMJE Bristol-Myers Squibb
Collaborators  ICMJE GlaxoSmithKline
Investigators  ICMJE
Study Director: GSK Clinical Trials ViiV Healthcare
PRS Account ViiV Healthcare
Verification Date July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP