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

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Completed
CT.gov ID
NCT04065932
Collaborator
(none)
33
Enrollment
1
Location
6
Arms
3.6
Actual Duration (Months)
9.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
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 :
Aug 22, 2019
Actual Primary Completion Date :
Dec 8, 2019
Actual Study Completion Date :
Dec 10, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Maximum observed plasma concentration (Cmax) for BMS-986165 [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 [Day 1 of treatment]

  3. 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

  1. Time to maximum observed plasma concentration-(Tmax) for BMS -986165 [Day 1 of treatment]

  2. Apparent plasma elimination half-life- (T-HALF) for BMS-986165 [Day 1 of treatment]

  3. Area under the concentration-time curve from time zero to 24 hours post- (AUC 0-24) for BMS-986165 [Day 1 of treatment]

  4. Apparent clearance -(CL/F) for BMS-986165 [Day 1 of treatment]

  5. Concentration observed at 24 hours-(C24) for BMS-986165 [Day 1 of treatment]

  6. Concentration observed at 12 hours-(C12) for BMS-986165 [Day 1 of treatment]

  7. Incidence of non-serious adverse events(AE's) leading to discontinuation of study therapy. [Approximately 16 weeks]

  8. Incidence of serious adverse events (SAE) leading to discontinuation of study therapy. [Approximately 16 weeks.]

  9. Incidence of adverse events (AEs) leading to discontinuation of study therapy. [Approximately 16 weeks.]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 55 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes

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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Quotient Sciences Nottingham United Kingdom NG11 6JS

Sponsors and Collaborators

  • Bristol-Myers Squibb

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT04065932
Other Study ID Numbers:
  • IM011-020
First Posted:
Aug 22, 2019
Last Update Posted:
Jan 6, 2021
Last Verified:
Jan 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
BMS-986165
Famotidine

Study Results

No Results Posted as of Jan 6, 2021