A Study to Evaluate the Drug-drug Interaction Potential of BMS-986196 in Healthy Participants
A Phase 1, Single-center, Open-label, Sequential Study to Evaluate the Drug-drug Interaction Potential of BMS-986196 in Healthy Participants
1 other identifier
interventional
18
1 country
1
Brief Summary
This study is designed to assess the effect of BMS-986196 on the drug levels of caffeine, montelukast, flurbiprofen, omeprazole, midazolam, digoxin, and pravastatin in healthy participants.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 healthy-volunteers
Started May 2023
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
May 1, 2023
CompletedFirst Posted
Study publicly available on registry
May 10, 2023
CompletedStudy Start
First participant enrolled
May 31, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 24, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 24, 2023
CompletedSeptember 26, 2023
September 1, 2023
3 months
May 1, 2023
September 25, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Maximum observed plasma concentration (Cmax)
Up to 26 days
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC[INF])
Up to 26 days
Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration (AUC[0-T])
Up to 26 days
Secondary Outcomes (9)
Time of maximum observed serum concentration (Tmax)
Up to 26 days
Apparent terminal phase half-life (T-Half)
Up to 26 days
Apparent total body clearance (CLT/F)
Up to 26 days
Number of participants with adverse events (AEs)
Up to 52 days
Number of participants with vital sign abnormalities
Up to 28 days
- +4 more secondary outcomes
Study Arms (1)
BMS-986196 and/or Cocktail Probe Substrate Drugs
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Healthy male and female participants as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations.
- Body mass index of 18.0 to 33.0 kilogram per meter squared (kg/m\^2), inclusive, and body weight ≥50.0 kg.
You may not qualify if:
- History of rhabdomyolysis.
- History of peptic ulcer disease or significant GI bleeding.
- History of malignancy in the 5 years prior to screening (except fully excised basal cell carcinoma).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
ICON plc
Millcreek, Utah, 84124, 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
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 1, 2023
First Posted
May 10, 2023
Study Start
May 31, 2023
Primary Completion
August 24, 2023
Study Completion
August 24, 2023
Last Updated
September 26, 2023
Record last verified: 2023-09
Data Sharing
- IPD Sharing
- Will not share
BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html