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

A Study to Determine the Pharmacokinetic Profile of BMS-986165 Administered as Various Solid Dispersion Tablet Formulations in Healthy Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04065932

Enrollment

Registered

2019-08-22

Start date

2019-08-22

Completion date

2019-12-10

Last updated

2021-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lupus

Brief summary

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

Interventions

DRUGBMS-986165-01

Participants will receive BMS- 986165 -01 in prototype formulation

DRUGBMS-986165 Tablet

Participants will receive BMS-986165 in tablet form.

DRUGFamotidine

Participants will receive a previously dosed BMS-985165-01 Prototype Tablet at the same dose level following administration of famotidine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com 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.

Design outcomes

Primary

Measure	Time frame
Maximum observed plasma concentration (Cmax) 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
Area under the plasma concentration-time curve from time zero extrapolated to infinite time- AUC(INF) for BMS-986165	Day 1 of treatment

Secondary

Measure	Time frame
Apparent clearance -(CL/F) for BMS-986165	Day 1 of treatment
Concentration observed at 24 hours-(C24) for BMS-986165	Day 1 of treatment
Concentration observed at 12 hours-(C12) for BMS-986165	Day 1 of treatment
Incidence of adverse events (AEs) leading to discontinuation of study therapy.	Approximately 16 weeks.
Incidence of serious adverse events (SAE) leading to discontinuation of study therapy.	Approximately 16 weeks.
Time to maximum observed plasma concentration-(Tmax) for BMS -986165	Day 1 of treatment
Incidence of non-serious adverse events(AE's) leading to discontinuation of study therapy.	Approximately 16 weeks
Apparent plasma elimination half-life- (T-HALF) 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

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026