A Study to Evaluate the Drug-drug Interaction Potential of BMS-986196 in Healthy Participants

• Sponsor: Bristol-Myers Squibb (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05852769
• Collaborator: (none)
• Enrollment: 18
• Arm: 1
• Anticipated Duration (Months): 3.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Drug: BMS-986196; Drug: Caffeine; Drug: Montelukast; Drug: Flurbiprofen; Drug: Omeprazole; Drug: Midazolam; Drug: Digoxin; Drug: Pravastatin	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 18 participants
• Allocation: N/A
• Intervention Model: Sequential Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase 1, Single-center, Open-label, Sequential Study to Evaluate the Drug-drug Interaction Potential of BMS-986196 in Healthy Participants
• Anticipated Study Start Date: May 18, 2023
• Anticipated Primary Completion Date: Aug 27, 2023
• Anticipated Study Completion Date: Aug 27, 2023

Arms and Interventions

Arm

Intervention/Treatment

Experimental: BMS-986196 and/or Cocktail Probe Substrate Drugs

Drug: BMS-986196; Specified dose on specified days; Drug: Caffeine; Specified dose on specified days; Drug: Montelukast; Specified dose on specified days; Drug: Flurbiprofen; Specified dose on specified days; Drug: Omeprazole; Specified dose on specified days; Drug: Midazolam; Specified dose on specified days; Drug: Digoxin; Specified dose on specified days; Drug: Pravastatin; Specified dose on specified days

Outcome Measures

Primary Outcome Measures

1. Maximum observed plasma concentration (Cmax) [Up to 26 days]

2. Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC[INF]) [Up to 26 days]

3. 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 Outcome Measures

1. Time of maximum observed serum concentration (Tmax) [Up to 26 days]

2. Apparent terminal phase half-life (T-Half) [Up to 26 days]

3. Apparent total body clearance (CLT/F) [Up to 26 days]

4. Number of participants with adverse events (AEs) [Up to 52 days]

5. Number of participants with vital sign abnormalities [Up to 28 days]

6. Number of participants with electrocardiogram (ECG) abnormalities [Up to 21 days]

7. Number of participants with physical examination abnormalities [Up to 28 days]

8. Number of participants with clinical laboratory abnormalities [Up to 28 days]

9. Intensity of Suicidal Ideation as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) Score [Up to 28 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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).

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Bristol-Myers Squibb

Investigators

• Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting
• Investigator Inquiry Form
• FDA Safety Alerts and Recalls

Publications

None provided.

• Responsible Party: Bristol-Myers Squibb
• ClinicalTrials.gov Identifier: NCT05852769
• Other Study ID Numbers: IM038-022
• First Posted: May 10, 2023
• Last Update Posted: May 10, 2023
• Last Verified: Apr 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Bristol-Myers Squibb: BMS-986196
• Additional relevant MeSH terms: Flurbiprofen; Digoxin; Midazolam; Caffeine; Omeprazole; Pravastatin; Montelukast

Study Results

No Results Posted as of May 10, 2023