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Drug-drug Interaction (DDI) Rifabutin

Sponsor
ViiV Healthcare (Industry)
Overall Status
Completed
CT.gov ID
NCT02138084
Collaborator
GlaxoSmithKline (Industry)
102
Enrollment
1
Location
2
Arms
2.3
Actual Duration (Months)
43.7
Patients Per Site Per Month

Study Details

Study Description

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
Phase 1

Study Design

Study Type:
Interventional
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 :
Jul 24, 2014
Actual Study Completion Date :
Jul 24, 2014

Arms and Interventions

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

Primary Outcome Measures

  1. Maximum observed plasma concentration (Cmax) of BMS-626529 [Day 2 to Day 15]

  2. Area under the concentration-time curve in 1 dosing interval [AUC(TAU)] of BMS-626529 [Day 2 to Day 15]

Secondary Outcome Measures

  1. Time of maximum observed plasma concentration (Tmax) of BMS-626529 [Day 2 to Day 15]

  2. Concentration at 12 hours after dosing (C12) of BMS-626529 [Day 2 to Day 15]

  3. Trough observed plasma concentration (Ctrough) of BMS-626529 (predose) [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) [Up to Day 30 after discontinuation of dose (approximately 45 days)]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes

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

Inclusion Criteria:
  1. Signed Written Informed Consent
  1. 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
  1. Target Population
    1. 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
    1. Body mass index (BMI) of 18.0 to 32.0 kg/m2, inclusive BMI = weight (kg)/[height (m)]2
    1. 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
  1. Age and Reproductive Status
    1. Men and women, ages 18 to 50 years, inclusive
    1. 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
    1. Women must not be breastfeeding
    1. 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
    1. 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

    1. Any significant acute or chronic medical illness as determined by the Investigator.
    1. Current or recent (within 3 months of study drug administration) gastrointestinal disease
    1. Any major surgery within 4 weeks of study drug administration
    1. Any gastrointestinal surgery that could impact upon the absorption of study drug
    1. Intractable diarrhea (≥6 loose stools per day for at least 7 consecutive days) within 30 days prior to the first dose of study drug
    1. History of acute or chronic pancreatitis
    1. History of active or latent tuberculosis or any recent exposure to someone with tuberculosis
    1. History of uveitis and/or current eye or vision problems with the exception of corrective lenses
    1. Contact lens use during study drug administration or the need for contact lenses during study drug administration
    1. 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)
    1. Blood transfusion within 4 weeks of study drug administration.
    1. History of any hemolytic disorders, including drug-induced hemolysis.
    1. Inability to tolerate oral medication
    1. Inability to be venipunctured and/or tolerate venous access
    1. Recent (within 6 months of study drug administration) history of smoking or current smokers
    1. 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
    1. Any other sound medical, psychiatric, and/or social reason as determined by the Investigator

Contacts and Locations

Locations

Site City State Country Postal Code
1 GSK Investigational Site Austin Texas United States 78744

Sponsors and Collaborators

  • ViiV Healthcare
  • GlaxoSmithKline

Investigators

  • Study Director: GSK Clinical Trials, ViiV Healthcare

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
ViiV Healthcare
ClinicalTrials.gov Identifier:
NCT02138084
Other Study ID Numbers:
  • 206282
  • AI438-041
First Posted:
May 14, 2014
Last Update Posted:
Sep 25, 2017
Last Verified:
Sep 1, 2017
Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Ritonavir
Fostemsavir
Rifabutin

Study Results

No Results Posted as of Sep 25, 2017