An Investigational Study of Experimental Medication BMS-986165 in Healthy Participants
An Open-label, Single-sequence Study to Investigate the Effects of BMS-986165 at Steady State on the Single Dose Pharmacokinetics of Mycophenolate Mofetil (MMF) in Healthy Male Subjects
1 other identifier
interventional
131
1 country
1
Brief Summary
The purpose of this study is to investigate the effects of experimental medication BMS-986165 in healthy male participants.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Aug 2018
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
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 14, 2018
CompletedFirst Submitted
Initial submission to the registry
September 4, 2018
CompletedFirst Posted
Study publicly available on registry
September 6, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 10, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 18, 2018
CompletedDecember 19, 2018
December 1, 2018
2 months
September 4, 2018
December 17, 2018
Conditions
Outcome Measures
Primary Outcomes (3)
Maximum plasma concentration (Cmax) of mycophenolic acid (MPA)
18 days
Area under the concentration vs time curve from time zero to the last quantifiable plasma concentration (AUC[0-T]) of MPA
18 days
AUC extrapolated to infinity (AUC[INF]) of MPA
18 days
Secondary Outcomes (4)
Number of adverse events (AE)
Up to 48 days
Number of serious adverse events (SAE)
Up to 48 days
Number of AEs leading to discontinuation
Up to 48 days
Incidence of clinically significant changes in laboratory test results, vital sign measurements, electrocardiograms (ECGs) and physical examination results
18 days
Study Arms (1)
BMS-986165 + MMF
EXPERIMENTALOral administration
Interventions
Eligibility Criteria
You may qualify if:
- Healthy participant, as determined by no clinically significant deviation from normal in physical examination, electrocardiograms (ECGs), and clinical laboratory determinations
- Body mass index of 18.0 to 32.0 kg/m2, inclusive, and weight ≥ 50 kg, at screening
- Normal renal function at screening as evidenced by an estimated GFR (glomerular filtration rate) \> 80 mL/min/1.732 m2
You may not qualify if:
- Any medical condition that presents a potential risk to the participant and/or may compromise the objectives of the study, including a history of or active liver disease
- Positive anti- John Cunningham virus (JCV) antibody test at Screening
- History of allergy to MMF, BMS-986165, related compounds or any significant drug allergy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
PRA Health Sciences
Salt Lake City, Utah, 84107, United States
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 4, 2018
First Posted
September 6, 2018
Study Start
August 14, 2018
Primary Completion
October 10, 2018
Study Completion
October 18, 2018
Last Updated
December 19, 2018
Record last verified: 2018-12