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Drug-drug Interaction (DDI) Rifabutin

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: NCT02138084
Recruitment Status : Completed
First Posted : May 14, 2014
Last Update Posted : September 25, 2017
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
ViiV Healthcare

Study Description
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Brief Summary:
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

Condition or disease Intervention/treatment Phase
Infection, Human Immunodeficiency Virus Drug: BMS-663068 Drug: Rifabutin Drug: Ritonavir Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 102 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: 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
Actual Study Start Date : May 14, 2014
Actual Primary Completion Date : July 24, 2014
Actual Study Completion Date : July 24, 2014

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Arms and Interventions
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Arm Intervention/treatment
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

 Drug: BMS-663068
BMS-663068

Drug: Rifabutin
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

 Drug: BMS-663068
BMS-663068

Drug: Rifabutin
Rifabutin

Drug: Ritonavir
Ritonavir


Outcome Measures
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Primary Outcome Measures :
  1. Maximum observed plasma concentration (Cmax) of BMS-626529 [ Time Frame: Day 2 to Day 15 ]
  2. Area under the concentration-time curve in 1 dosing interval [AUC(TAU)] of BMS-626529 [ Time Frame: Day 2 to Day 15 ]

Secondary Outcome Measures :
  1. Time of maximum observed plasma concentration (Tmax) of BMS-626529 [ Time Frame: Day 2 to Day 15 ]
  2. Concentration at 12 hours after dosing (C12) of BMS-626529 [ Time Frame: Day 2 to Day 15 ]
  3. Trough observed plasma concentration (Ctrough) of BMS-626529 (predose) [ Time Frame: Day 2 to Day 15 ]
  4. 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) ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02138084


Locations
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United States, Texas
GSK Investigational Site
Austin, Texas, United States, 78744
Sponsors and Collaborators
ViiV Healthcare
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials ViiV Healthcare
More Information
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Responsible Party: ViiV Healthcare
ClinicalTrials.gov Identifier: NCT02138084    
Other Study ID Numbers: 206282
AI438-041 ( Other Identifier: Bristol-Myers Squibb )
First Posted: May 14, 2014    Key Record Dates
Last Update Posted: September 25, 2017
Last Verified: September 2017
Additional relevant MeSH terms:
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Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Ritonavir
Rifabutin
 HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Anti-Bacterial Agents
Antibiotics, Antitubercular
Antitubercular Agents