An Investigational Study to Determine the Drug Level Profile of BMS-986165 in Healthy Male Volunteers Following Transporter Inhibition.

Phase 1

Completed

• Conditions: Healthy Male Volunteers
• Interventions: Drug: BMS-986165; Drug: Pyrimethamine

• Registration Number: NCT04086719
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

Study of what the body does to drug BMS-986165 when it is taken together with pyrimethamine

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-09-10
• Study First Submitted QC: 2019-09-10
• Study Start: 2019-09-12
• Study First Posted: 2019-09-12
• Primary Completion: 2019-10-29
• Study Completion: 2019-10-29
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-03
• Last Update Posted: 2020-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 16

Inclusion Criteria

• Patients must be willing and able to complete all study-specific procedures and visits
• Healthy patients, as determined by no clinically significant deviation from normal in medical history, physical examination, electrocardiogram, and clinical laboratory determinations
• Body mass index (BMI) of 18 to 32 kg/m2, inclusive, at screening
• Normal renal function at screening

Exclusion Criteria

• Any medical condition that presents a potential risk to the participant and/or may compromise the objectives of the study, including a history of or active liver disease
• Current or recent (within 3 months of study drug administration) gastrointestinal disease that could impact upon the absorption of study drug
• History or presence of clinically significant acute or chronic bacterial, fungal, or viral infection (eg, pneumonia, septicemia) within the 3 months prior to screening
• Additional criteria may apply

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
BMS-986185	BMS-986165	-
BMS- 986185 + Pyrimethamine	Pyrimethamine	-

Primary Outcome Measures

Name	Time	Method
Area under the concentration-time curve from time zero extrapolated to AUC(INF)	Day 1, Day 5
Maximum observed serum comcentration (Cmax)	Day 1, Day 5

Secondary Outcome Measures

Name	Time	Method
Incidences of Adverse Events (AE's)	Approximetly 20 days
Time of maximum observed concentration (Tmax)	Approxmiately 20 days
Half- life time (T-Half)	Day 1, Day 5
Apparent oral clearance (CL/F)	Day 5
Ratio of metabolite AUC(INF) to parent AUC(INF) corrected for Moecular weight MRAUC(INF)	Day 5
Apparent volume of distribution at terminal phase (Vz/F)	Day 5
Ratio of metabolite AUC(0-T) to parent AUC(0-T) corrected for Molecular weight MRAUC(0-T)	Day 5

Trial Locations

Locations (1)

PRA Health Sciences - Salt Lake; 🇺🇸 Salt Lake City, Utah, United States