A Study to Assess the Effect of BMS-986419 on the Single Dose Drug Levels of Probe Substrates in Healthy Participants
A Phase 1 Open-label Study to Assess the Effect of BMS-986419 on the Single Dose Pharmacokinetics of Probe Substrates (Caffeine, Bupropion, Flurbiprofen, Omeprazole, Midazolam, and Fexofenadine) in Healthy Participants
1 other identifier
interventional
22
1 country
1
Brief Summary
The purpose of this study is to assess the effect of BMS-986419 on the pharmacokinetics (PK) of single doses of caffeine (CYP1A2 substrate), bupropion (CYP2B6 substrate), midazolam (CYP3A4 substrate), flurbiprofen (CYP2C9 substrate), omeprazole (CYP2C19 substrate), and fexofenadine (P-gp substrate), in healthy participants.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 healthy-volunteers
Started Jun 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
June 27, 2023
CompletedStudy Start
First participant enrolled
June 29, 2023
CompletedFirst Posted
Study publicly available on registry
July 6, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 13, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 13, 2023
CompletedOctober 30, 2023
October 1, 2023
3 months
June 27, 2023
October 27, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Maximum observed plasma concentration (Cmax)
Up to Day 25
Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration (AUC(0-T))
Up to Day 25
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF))
Up to Day 25
Secondary Outcomes (11)
Maximum observed plasma concentration (Cmax)
Up to Day 25
Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration (AUC(0-T))
Up to Day 25
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF))
Up to Day 25
Number of participants with Adverse Events (AEs)
Up to 28 days after last dose
Number of participants with Serious Adverse Events (SAEs)
Up to 28 days after last dose
- +6 more secondary outcomes
Study Arms (1)
Cocktail Probe Substrates + BMS-986419
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Healthy male and female participants without clinically significant deviation from normal in medical history, physical examination (PE), electrocardiogram (ECG), and clinical laboratory determinations (congenital nonhemolytic hyperbilirubinemia \[eg, suspicion of Gilbert's syndrome based on total and direct bilirubin\] is not acceptable) at screening and check-in (Day -1).
- Body Mass Index (BMI) of 18 to 32 kg/m2, inclusive, and total body weight ≥ 50 kg. BMI may be rounded.
You may not qualify if:
- Any significant acute or chronic medical conditions or any significant acute or chronic medical illness as determined by the investigator
- Any major surgery within 30 days of study intervention administration, such as gastrointestinal surgery that could impact the absorption of study intervention
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
ICON Lenexa
Lenexa, Kansas, 66219, 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
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 27, 2023
First Posted
July 6, 2023
Study Start
June 29, 2023
Primary Completion
September 13, 2023
Study Completion
September 13, 2023
Last Updated
October 30, 2023
Record last verified: 2023-10