A Study to Evaluate the Effect of 2 Drugs on the Pharmacokinetics of BMS-986205 in Healthy Subjects
A Randomized, Open-Label, Four-Cohort, Parallel Design Study to Evaluate the Effect of Itraconazole or Rifampin on the Single-Dose Pharmacokinetics of BMS-986205 in Normal Healthy Participants
1 other identifier
interventional
53
1 country
1
Brief Summary
Assess the effects of itraconazole and rifampin on the pharmacokinetics, safety, and tolerability of BMS-986205.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Nov 2017
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 6, 2017
CompletedFirst Posted
Study publicly available on registry
November 17, 2017
CompletedStudy Start
First participant enrolled
November 22, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 20, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 20, 2017
CompletedFebruary 28, 2018
February 1, 2018
28 days
November 6, 2017
February 26, 2018
Conditions
Outcome Measures
Primary Outcomes (3)
Maximum observed plasma concentration (Cmax)
Measured by plasma concentration
Up to 25 days
AUC from time zero to time of last quantifiable concentration (AUC(0-T))
Measured by plasma concentration
Up to 25 days
AUC from time zero extrapolated to infinite time (AUC(INF))
Measured by plasma concentration
Up to 25 days
Secondary Outcomes (5)
Incidence of Adverse Events (AEs)
Up to 25 days
Incidence of Serious Adverse Events (SAEs)
Up to 76 days
Number of participants with electrocardiogram abnormalities
Up to 25 days
Number of participants with physical examination findings abnormalities
Up to 25 days
Number of participants with clinical laboratory abnormalities
Up to 25 days
Study Arms (4)
Inhibition (Cohort 1)
EXPERIMENTALSingle oral dose BMS-986205
Inhibition (Cohort 2)
EXPERIMENTALDaily oral itraconazole doses for 24 days; single oral dose BMS-986205 on day 4
Induction (Cohort 3)
EXPERIMENTALSingle oral dose BMS-986205
Induction (Cohort 4)
EXPERIMENTALDaily oral rifampin doses for21 days; single oral dose BMS-986205 on day 8
Interventions
BMS-986205
Eligibility Criteria
You may qualify if:
- Body mass index 18.0 to 32.0 kg/m2, inclusive
- Must have normal renal function demonstrated by GFR, calculated by Chronic Kidney Disease Epidemiology Collaboration formula
- Women must not be of childbearing potential (cannot become pregnant)
You may not qualify if:
- Any significant acute or chronic medical illness
- History of glucose-6-phosphodiesterase (G6PD) deficiency
- Personal or family history of cytochrome b5 reductase deficiency
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
PPD
Austin, Texas, 78744, United States
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Briston-Myers Squibb
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 6, 2017
First Posted
November 17, 2017
Study Start
November 22, 2017
Primary Completion
December 20, 2017
Study Completion
December 20, 2017
Last Updated
February 28, 2018
Record last verified: 2018-02