A Study to Determine the Pharmacokinetic Profile of BMS-986165 Tablets

Phase 1

Completed

• Conditions: Lupus
• Interventions: Drug: BMS-986165-01; Drug: BMS-986165 Tablet; Drug: Famotidine

• Registration Number: NCT04065932
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

A Study to Determine the Drug Level Profile of Different formulations of BMS-986165 Tablets

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-08-21
• Study First Submitted QC: 2019-08-21
• Study Start: 2019-08-22
• Study First Posted: 2019-08-22
• Primary Completion: 2019-12-08
• Study Completion: 2019-12-10
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-05
• Last Update Posted: 2021-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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

• History or presence of chronic bacterial, viral infection, or autoimmune disorder
• Active TB requiring treatment or documented latent TB within the previous 3 years
• Current or recent (within 3 months of study treatment administration) gastrointestinal disease that could affect absorption
• WOCBP (women of childbearing potential) must have negative serum or urine pregnancy test.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BMS-985165-01 prototype formulation 1	BMS-986165-01	-
BMS-986165 Tablet	BMS-986165 Tablet	-
BMS-985165-01 prototype formulation 2	BMS-986165-01	-
BMS-985165-01 prototype formulation 3	BMS-986165-01	-
BMS-985165-01 prototype formulation 3 or 4	BMS-986165-01	-
BMS-985165-01 prototype formulation 3 or 4	Famotidine	-
BMS-985165-01 prototype formulation 3, 4 or 5	BMS-986165-01	-
BMS-985165-01 prototype formulation 3, 4 or 5	Famotidine	-

Primary Outcome Measures

Name	Time	Method
Maximum observed plasma concentration (Cmax) for BMS-986165	Day 1 of treatment
Area under the plasma concentration-time curve from time zero extrapolated to infinite time- AUC(INF) for BMS-986165	Day 1 of treatment
Area under the serum concentration-time curve from time zero to time of last quantifiable concentration- AUC(0-T) for BMS- 986165	Day 1 of treatment

Secondary Outcome Measures

Name	Time	Method
Apparent plasma elimination half-life- (T-HALF) for BMS-986165	Day 1 of treatment
Concentration observed at 12 hours-(C12) for BMS-986165	Day 1 of treatment
Incidence of non-serious adverse events(AE's) leading to discontinuation of study therapy.	Approximately 16 weeks
Time to maximum observed plasma concentration-(Tmax) for BMS -986165	Day 1 of treatment
Area under the concentration-time curve from time zero to 24 hours post- (AUC 0-24) for BMS-986165	Day 1 of treatment
Apparent clearance -(CL/F) for BMS-986165	Day 1 of treatment
Incidence of serious adverse events (SAE) leading to discontinuation of study therapy.	Approximately 16 weeks.
Concentration observed at 24 hours-(C24) for BMS-986165	Day 1 of treatment
Incidence of adverse events (AEs) leading to discontinuation of study therapy.	Approximately 16 weeks.

Trial Locations

Locations (1)

Quotient Sciences; 🇬🇧 Nottingham, United Kingdom