Study to Characterize the Effects of Cytochrome p450 1A2 Inhibition on Systemic Exposure to BMS-986165
An Open-label, Single-sequence Study to Investigate the Effects of Cytochrome P450 1A2 Inhibition on the Pharmacokinetics of BMS-986165 in Healthy Participants
1 other identifier
interventional
16
1 country
1
Brief Summary
To compare the pharmacokinetic characteristics of BMS-986165 after a single-dose administration alone vs. in combination with fluvoxamine (CYP1A2 inhibitor)
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
Started May 2019
Shorter than P25 for phase_1 healthy
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
April 26, 2019
CompletedFirst Posted
Study publicly available on registry
April 29, 2019
CompletedStudy Start
First participant enrolled
May 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 27, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 27, 2019
CompletedNovember 17, 2021
November 1, 2021
26 days
April 26, 2019
November 9, 2021
Conditions
Outcome Measures
Primary Outcomes (3)
Maximum observed plasma concentration (Cmax) of BMS-986165
10 days
AUC(0-T) of BMS-986165
10 days
AUC(INF) of BMS-986165
10 days
Secondary Outcomes (5)
Fluvoxamine steady-state plasma concentrations
10 days
Percentage of participants with Adverse events (AEs)
From screening up to end of drug treatment (Day 13)
Percentage of participants with Serious Adverse events (SAEs) and Death
From screening up to end of drug treatment (Day 13)
Percentage of participants with Adverse events (AEs) leading to discontinutation
From screening up to end of drug treatment (Day 13)
Percentage of participants with clinical significant laboratory abnormalities vital sign measurements and ECGs
From screening up to end of drug treatment (Day 13)
Study Arms (3)
BMS-986165+Fluvoxamine
EXPERIMENTALBMS-986165 only
EXPERIMENTALFluvoxamine only
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Healthy participant, as determined by no clinically significant deviation from normal in medical history, physical examination, electrocardiograms (ECGs), and clinical laboratory determinations in the opinion of the investigator.
- Body mass index of 18 to 32 kilograms per square meter (kg/m2), inclusive, and body weight ≥ 50 kg, at screening.
- Normal renal function at screening as evidenced by an estimated glomerular filtration rate (GFR) \> 80 milliliter/minute/1.732 meter square calculated with the Chronic Kidney Disease Epidemiology Collaboration formula.
You may not qualify if:
- Any significant acute or chronic medical condition that presents a potential risk to the participant and/or may compromise the objectives of the study,
- Any major surgery within 4 weeks of study drug administration
- Participants who currently smoke, as well as those who have stopped smoking less than 6 months prior to dosing on Day 1.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
ICON Plc (PRA Health Sciences)
Salt Lake City, 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
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 26, 2019
First Posted
April 29, 2019
Study Start
May 1, 2019
Primary Completion
May 27, 2019
Study Completion
May 27, 2019
Last Updated
November 17, 2021
Record last verified: 2021-11