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Pharmacokinetics (Drug Levels in Blood) of BMS-986165 When Taken as Various Solid Tablet Prototypes by Healthy Participants

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Completed
CT.gov ID
NCT04249284
Collaborator
(none)
18
Enrollment
1
Location
4
Arms
1.2
Actual Duration (Months)
14.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to characterize the pharmacokinetics (the way the body absorbs, distributes and eliminates the drug) of BMS 986165 given in the form of various prototypes of solid tablets to healthy participants.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
18 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Study to Evaluate the Pharmacokinetics of BMS-986165 Administered as Various Prototypic Solid Tablet Formulations in Healthy Subjects
Actual Study Start Date :
Feb 6, 2020
Actual Primary Completion Date :
Mar 15, 2020
Actual Study Completion Date :
Mar 15, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment A : BMS-986165

Drug: BMS-986165
Specified dose on specified days
Experimental: Treatment B: BMS-986165 prototype 1

Drug: BMS-986165 prototype 1
Specified dose on specified days
Experimental: Treatment C: BMS-986165 prototype 2

Drug: BMS-986165 prototype 2
Specified dose on specified days
Experimental: Treatment D: BMS-986165 prototype 2

Drug: BMS-986165 prototype 2
Specified dose on specified days

Outcome Measures

Primary Outcome Measures

  1. Maximum concentration (Cmax) for BMS-986165 in plasma [Up to 18 days]

  2. Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (AUC(0-T)) for BMS-986165 in plasma [Up to 18 days]

  3. Area under the plasma concentration-time curve extrapolated to infinity (AUC(INF)) for BMS-986165 in plasma [Up to 18 days]

Secondary Outcome Measures

  1. Incidence of Adverse Events (AEs) [Up to 23 days]

  2. Incidence of Serious Adverse Events (SAEs) [Up to 55 days]

  3. Number of clinically significant abnormalities in electrocardiogram (ECG) parameters [Up to 50 days]

  4. Number of participants with vital sign abnormalities in body temperature [Up to 50 days]

  5. Number of participants with vital sign abnormalities in respiratory rate [Up to 50 days]

  6. Number of participants with vital sign abnormalities in heart rate [Up to 50 days]

  7. Number of participants with vital sign abnormalities in blood pressure [Up to 50 days]

  8. Number of participants with clinical laboratory test abnormalities: Hematology tests [Up to 50 days]

  9. Number of participants with clinical laboratory test abnormalities: Clinical chemistry tests [Up to 50 days]

  10. Number of participants with clinical laboratory test abnormalities: Urinalysis tests [Up to 50 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 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:

  • In the opinion of the investigator, a healthy participant is determined by having no clinically significant deviation from normal in medical history, physical examination,electrocardiograms, vital signs, and clinical laboratory determinations.

  • Body weight >= 50 kg at screening

  • Women and men must agree to follow specific methods of contraception, if applicable

Exclusion Criteria:

  • Any major surgery, per investigator's discretion, within 4 weeks of study drug administration

  • Inability to tolerate oral medication

  • History of allergy to BMS-986165 or related compounds

Other protocol-defined inclusion/exclusion criteria apply

Contacts and Locations

Locations

Site City State Country Postal Code
1 Quotient Sciences Miami Miami Florida United States 33126

Sponsors and Collaborators

  • Bristol-Myers Squibb

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT04249284
Other Study ID Numbers:
  • IM011-096
First Posted:
Jan 30, 2020
Last Update Posted:
Apr 9, 2020
Last Verified:
Apr 1, 2020
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
BMS-986165

Study Results

No Results Posted as of Apr 9, 2020