Clinical trial NCT04065932: A Study to Determine the Pharmacokinetic Profile of BMS-986165 Tablets
Official title: A Study to Determine the Pharmacokinetic Profile of BMS-986165 Administered as Various Solid Dispersion Tablet Formulations in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Lupus
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2019-08-22
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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.

Primary outcomes:
measure: Maximum observed plasma concentration (Cmax) for BMS-986165
timeFrame: Day 1 of treatment
measure: Area under the serum concentration-time curve from time zero to time of last quantifiable concentration- AUC(0-T) for BMS- 986165
timeFrame: Day 1 of treatment
measure: Area under the plasma concentration-time curve from time zero extrapolated to infinite time- AUC(INF) for BMS-986165
timeFrame: Day 1 of treatment
Secondary outcomes:
measure: Time to maximum observed plasma concentration-(Tmax) for BMS -986165
timeFrame: Day 1 of treatment
measure: Apparent plasma elimination half-life- (T-HALF) for BMS-986165
timeFrame: Day 1 of treatment
measure: Area under the concentration-time curve from time zero to 24 hours post- (AUC 0-24) for BMS-986165
timeFrame: Day 1 of treatment
measure: Apparent clearance -(CL/F) for BMS-986165
timeFrame: Day 1 of treatment
measure: Concentration observed at 24 hours-(C24) for BMS-986165
timeFrame: Day 1 of treatment
measure: Concentration observed at 12 hours-(C12) for BMS-986165
timeFrame: Day 1 of treatment
measure: Incidence of non-serious adverse events(AE's) leading to discontinuation of study therapy.
timeFrame: Approximately 16 weeks
measure: Incidence of serious adverse events (SAE) leading to discontinuation of study therapy.
timeFrame: Approximately 16 weeks.
measure: Incidence of adverse events (AEs) leading to discontinuation of study therapy.
timeFrame: Approximately 16 weeks.
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: Quotient Sciences
Study officials:
References: