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Drug-drug Interaction (DDI) Rifabutin

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT02138084
First received: May 13, 2014
Last updated: September 10, 2014
Last verified: September 2014

May 13, 2014
September 10, 2014
May 2014
July 2014   (final data collection date for primary outcome measure)
  • Maximum observed plasma concentration (Cmax) of BMS-626529 [ Time Frame: Day 2 to Day 15 ] [ Designated as safety issue: No ]
  • Area under the concentration-time curve in 1 dosing interval [AUC(TAU)] of BMS-626529 [ Time Frame: Day 2 to Day 15 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT02138084 on ClinicalTrials.gov Archive Site
  • Time of maximum observed plasma concentration (Tmax) of BMS-626529 [ Time Frame: Day 2 to Day 15 ] [ Designated as safety issue: No ]
  • Concentration at 12 hours after dosing (C12) of BMS-626529 [ Time Frame: Day 2 to Day 15 ] [ Designated as safety issue: No ]
  • Trough observed plasma concentration (Ctrough) of BMS-626529 (predose) [ Time Frame: Day 2 to Day 15 ] [ Designated as safety issue: No ]
  • Safety and tolerability include incidence of adverse events (AEs), serious AEs (SAEs), AEs leading to discontinuation, deaths, marked laboratory abnormalities, and abnormalities in vital signs, physical examination, and 12-lead electrocardiograms (ECGs) [ Time Frame: Up to Day 30 after discontinuation of dose (approximately 45 days) ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Drug-drug Interaction (DDI) Rifabutin
Pharmacokinetic Interaction Study to Evaluate the Pharmacokinetic Effect of Rifabutin on BMS-626529, the Active Moiety of BMS-663068, With and Without Ritonavir in Healthy Subjects

The purpose of this study is to provide dosing recommendations for the coadministration of BMS-663068 and Rifabutin with and without Ritonavir in upcoming Phase 3 studies and for prescribing information purposes

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
HIV/AIDS
  • Drug: BMS-663068
  • Drug: Rifabutin
  • Drug: Ritonavir
  • Experimental: Cohort 1: BMS-663068 + Rifabutin

    Regimen A: BMS-663068 tablet by mouth as specified

    Regimen B: BMS-663068 tablet with Rifabutin capsule by mouth as specified

    Interventions:
    • Drug: BMS-663068
    • Drug: Rifabutin
  • Experimental: Cohort 2: BMS-663068 + Rifabutin + Ritonavir

    Regimen A: BMS-663068 tablet by mouth as specified

    Regimen C: BMS-663068 tablet, Rifabutin capsule and Ritonavir (RTV) capsule by mouth as specified

    Interventions:
    • Drug: BMS-663068
    • Drug: Rifabutin
    • Drug: Ritonavir
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
46
July 2014
July 2014   (final data collection date for primary outcome measure)

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria:

  1. Signed Written Informed Consent

    a) Signed written informed consent must be obtained from the subjects in accordance with requirements of the study center's Institutional Review Board (IRB) or Independent Ethics Committee (IEC) before the initiation of any protocol-required procedures

  2. Target Population

    • a) Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination findings, 12-lead ECG measurements, and clinical laboratory test results
    • b) Body mass index (BMI) of 18.0 to 32.0 kg/m2, inclusive BMI = weight (kg)/[height (m)]2
    • c) Subject Reenrollment: This study permits the reenrollment of a subject that has discontinued the study as a pretreatment failure (ie, subject has not been randomized/has not been dosed). If reenrolled, the subject must be reconsented
  3. Age and Reproductive Status

    • a) Men and women, ages 18 to 50 years, inclusive
    • b) Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin) within 24 hours prior to the start of study drug
    • c) Women must not be breastfeeding
    • d) WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment plus 5 half-lives of Rifabutin (13 days) plus 30 days (duration of ovulatory cycle) for a total of 43 days posttreatment completion
    • e) Men who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment plus 5 half-lives of Rifabutin (13 days) plus 90 days (duration of sperm turnover) for a total of 103 days posttreatment completion

Exclusion Criteria:

Medical History and Concurrent Diseases

  • a) Any significant acute or chronic medical illness as determined by the Investigator.
  • b) Current or recent (within 3 months of study drug administration) gastrointestinal disease
  • c) Any major surgery within 4 weeks of study drug administration
  • d) Any gastrointestinal surgery that could impact upon the absorption of study drug
  • e) Intractable diarrhea (≥6 loose stools per day for at least 7 consecutive days) within 30 days prior to the first dose of study drug
  • f) History of acute or chronic pancreatitis
  • g) History of active or latent tuberculosis or any recent exposure to someone with tuberculosis
  • h) History of uveitis and/or current eye or vision problems with the exception of corrective lenses
  • i) Contact lens use during study drug administration or the need for contact lenses during study drug administration
  • j) Donation of blood to a blood bank or in a clinical study (except screening visit) within 4 weeks of study drug administration (within 2 weeks for plasma donation only)
  • k) Blood transfusion within 4 weeks of study drug administration.
  • l) History of any hemolytic disorders, including drug-induced hemolysis.
  • m) Inability to tolerate oral medication
  • n) Inability to be venipunctured and/or tolerate venous access
  • o) Recent (within 6 months of study drug administration) history of smoking or current smokers
  • p) Recent (within 6 months of study drug administration) drug or alcohol abuse as defined in Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM IV), Diagnostic Criteria for Drug and Alcohol Abuse
  • q) Any other sound medical, psychiatric, and/or social reason as determined by the Investigator
Both
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT02138084
AI438-041
No
Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
September 2014

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