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

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

Study Overview

• Status: Completed
• Conditions: Lupus
• Intervention / Treatment: Drug: BMS-986165-01; Drug: BMS-986165 Tablet; Drug: Famotidine

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Nottingham, United Kingdom, NG11 6JS
    • Quotient Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BMS-985165-01 prototype formulation 1	Drug: BMS-986165-01; Participants will receive BMS- 986165 -01 in prototype formulation
Experimental: BMS-986165 Tablet	Drug: BMS-986165 Tablet; Participants will receive BMS-986165 in tablet form.
Experimental: BMS-985165-01 prototype formulation 2	Drug: BMS-986165-01; Participants will receive BMS- 986165 -01 in prototype formulation
Experimental: BMS-985165-01 prototype formulation 3	Drug: BMS-986165-01; Participants will receive BMS- 986165 -01 in prototype formulation
Experimental: BMS-985165-01 prototype formulation 3 or 4	Drug: BMS-986165-01; Participants will receive BMS- 986165 -01 in prototype formulation; Drug: Famotidine; Participants will receive a previously dosed BMS-985165-01 Prototype Tablet at the same dose level following administration of famotidine
Experimental: BMS-985165-01 prototype formulation 3, 4 or 5	Drug: BMS-986165-01; Participants will receive BMS- 986165 -01 in prototype formulation; Drug: Famotidine; Participants will receive a previously dosed BMS-985165-01 Prototype Tablet at the same dose level following administration of famotidine

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	Time Frame
Time to maximum observed plasma concentration-(Tmax) for BMS -986165	Day 1 of treatment
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
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 non-serious adverse events(AE's) leading to discontinuation of study therapy.	Approximately 16 weeks
Incidence of serious adverse events (SAE) leading to discontinuation of study therapy.	Approximately 16 weeks.
Incidence of adverse events (AEs) leading to discontinuation of study therapy.	Approximately 16 weeks.

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting
• FDA Safety Alerts and Recalls

Study record dates

Study Major Dates

• Study Start (Actual): August 22, 2019
• Primary Completion (Actual): December 8, 2019
• Study Completion (Actual): December 10, 2019

Study Registration Dates

• First Submitted: August 21, 2019
• First Submitted That Met QC Criteria: August 21, 2019
• First Posted (Actual): August 22, 2019

Study Record Updates

• Last Update Posted (Actual): January 6, 2021
• Last Update Submitted That Met QC Criteria: January 5, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Dermatologic Agents; Protein Kinase Inhibitors; Anti-Ulcer Agents; Histamine Antagonists; Histamine Agents; Histamine H2 Antagonists; Famotidine; BMS-986165
• Other Study ID Numbers: IM011-020

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No