Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04065932
Recruitment Status : Completed
First Posted : August 22, 2019
Last Update Posted : December 26, 2019
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

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

Condition or disease Intervention/treatment Phase
Lupus Drug: BMS-986165-01 Drug: BMS-986165 Tablet Drug: Famotidine Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Study to Determine the Pharmacokinetic Profile of BMS-986165 Administered as Various Solid Dispersion Tablet Formulations in Healthy Subjects
Actual Study Start Date : August 22, 2019
Actual Primary Completion Date : December 8, 2019
Actual Study Completion Date : December 10, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Famotidine

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




Primary Outcome Measures :
  1. Maximum observed plasma concentration (Cmax) for BMS-986165 [ Time Frame: Day 1 of treatment ]
  2. Area under the serum concentration-time curve from time zero to time of last quantifiable concentration- AUC(0-T) for BMS- 986165 [ Time Frame: Day 1 of treatment ]
  3. Area under the plasma concentration-time curve from time zero extrapolated to infinite time- AUC(INF) for BMS-986165 [ Time Frame: Day 1 of treatment ]

Secondary Outcome Measures :
  1. Time to maximum observed plasma concentration-(Tmax) for BMS -986165 [ Time Frame: Day 1 of treatment ]
  2. Apparent plasma elimination half-life- (T-HALF) for BMS-986165 [ Time Frame: Day 1 of treatment ]
  3. Area under the concentration-time curve from time zero to 24 hours post- (AUC 0-24) for BMS-986165 [ Time Frame: Day 1 of treatment ]
  4. Apparent clearance -(CL/F) for BMS-986165 [ Time Frame: Day 1 of treatment ]
  5. Concentration observed at 24 hours-(C24) for BMS-986165 [ Time Frame: Day 1 of treatment ]
  6. Concentration observed at 12 hours-(C12) for BMS-986165 [ Time Frame: Day 1 of treatment ]
  7. Incidence of non-serious adverse events(AE's) leading to discontinuation of study therapy. [ Time Frame: Approximately 16 weeks ]
  8. Incidence of serious adverse events (SAE) leading to discontinuation of study therapy. [ Time Frame: Approximately 16 weeks. ]
  9. Incidence of adverse events (AEs) leading to discontinuation of study therapy. [ Time Frame: Approximately 16 weeks. ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04065932


Locations
Layout table for location information
United Kingdom
Quotient Sciences
Nottingham, United Kingdom, NG11 6JS
Sponsors and Collaborators
Bristol-Myers Squibb
Additional Information:
Layout table for additonal information
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT04065932    
Other Study ID Numbers: IM011-020
First Posted: August 22, 2019    Key Record Dates
Last Update Posted: December 26, 2019
Last Verified: December 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
BMS-986165
Famotidine
Anti-Ulcer Agents
Gastrointestinal Agents
Histamine H2 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Dermatologic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors