A Study to Evaluate the Effect of Food on the Drug Levels of BMS-986196 in Healthy Adult Participants

Healthy Adult Volunteers Clinical Trial

Official title:

A Phase 1, 2-part, Open-label, Randomized, 2-period, 2-sequence, Crossover Study to Evaluate the Effect of Food on the Pharmacokinetics of BMS-986196 Phase 2 Tablet Formulation at Two Dose Levels in Healthy Adult Participants

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT06034899
• Other study ID #: IM038-1014
• Status: Withdrawn
• Phase: Phase 1
• Start date: September 22, 2023
• Est. completion date: November 30, 2023

Study information

• Verified date: September 2023
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess the drug levels of BMS-986196 and to evaluate the effect of food (fasted versus fed [high-fat meal]) on the drug levels after administration of BMS-986196 tablet formulation at two dose levels in healthy adult participants.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 30, 2023
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Healthy male participants and female participants without clinically significant deviation from normal, as determined by the investigator, in medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory assessments.
• Body mass index of 18.0 to 35.0 kilograms/meter square (kg/m^2), inclusive, and body weight = 50 kg.
• Participant must agree and be willing to consume a standard high-fat meal (for example, which may contain gluten).

Exclusion Criteria:

• Any significant acute or chronic medical illness in the assessment of the investigator.
• Current or recent (within 3 months of study intervention) gastrointestinal (GI) disease that could possibly affect drug absorption, distribution, metabolism, and excretion (e.g., bariatric procedure)
• Any major surgery, including GI surgery (for example, cholecystectomy and any other GI surgery) that could impact upon the absorption of study intervention (uncomplicated appendectomy and hernia repair are acceptable). Note: Other protocol-defined inclusion/exclusion criteria apply.

Related Conditions & MeSH terms

• Healthy Adult Volunteers

Intervention

Drug:
• BMS-986196
Specified dose on specified days

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the serum concentration-time curve from time zero to time of last quantifiable concentration (AUC [0-T])		Predose and post-dose up to Day 10
Primary	Maximum observed serum concentration (Cmax)		Predose and post-dose up to Day 10
Primary	Time of Cmax (Tmax)		Predose and post-dose up to Day 10
Secondary	Number of participants with adverse events (AEs)		Up to Day 36
Secondary	Number of participants with serious AEs (SAEs)		Up to Day 36
Secondary	Number of participants with vital sign abnormalities		Up to Day 11
Secondary	Number of participants with electrocardiogram (ECG) abnormalities		Up to Day 11
Secondary	Change from baseline in columbia-suicide severity rating scale (C-SSRS) at day 11		Baseline, Day 11
Secondary	Number of participants with physical examination findings		Up to Day 11
Secondary	Number of participants with clinical laboratory abnormalities		Up to Day 11

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting