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Evaluate the Pharmacokinetics of BMS-986177 From Two Formulations in Healthy Participants

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Completed
CT.gov ID
NCT03362437
Collaborator
(none)
12
Enrollment
1
Location
3
Arms
1.4
Actual Duration (Months)
8.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Assess the pharmacokinetics (fasting and fed), safety, and tolerability of BMS-986177 following oral dosing of Form A and Form B

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
12 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
A Study to Evaluate the Pharmacokinetics of BMS-986177 From Form A and Form B in Healthy Participants
Actual Study Start Date :
Nov 15, 2017
Actual Primary Completion Date :
Dec 28, 2017
Actual Study Completion Date :
Dec 28, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment A

Receive 200 mg BMS-986177 Form A without food

Drug: BMS-986177
Form A
Experimental: Treatment B

Receive 200 mg BMS-986177 Form B without food

Drug: BMS-986177
Form B
Experimental: Treatment C

Receive 200 mg BMS-986177 Form B with food

Drug: BMS-986177
Form B

Outcome Measures

Primary Outcome Measures

  1. Maximum observed plasma concentration (Cmax) [Up to 3 days]

    Measured by plasma concentration

  2. AUC from time zero to time of last quantifiable concentration (AUC(0-T)) [Up to 3 days]

    Measured by plasma concentration

  3. AUC from time zero extrapolated to infinite time (AUC(INF)) [Up to 3 days]

    Measured by plasma concentration

Secondary Outcome Measures

  1. Incidence of Adverse Events (AEs) [Up to 12 days]

    Safety and tolerability as measured by incidence of AEs

  2. Incidence of Serious Adverse Events (SAEs) [Up to 30 days]

    Safety and tolerability as measured by incidence of SAEs

  3. Number of participants with electrocardiogram abnormalities [Up to 12 days]

  4. Number of participants with physical examination abnormalities [Up to 12 days]

  5. Number of participants with clinical laboratory abnormalities [Up to 12 days]

Eligibility Criteria

Criteria

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

  • Body mass index 18.0 to 32.0 kg/m2, inclusive

  • Women must not be of childbearing potential (cannot become pregnant)

Exclusion Criteria:

  • Any significant acute or chronic medical illness

  • Head injury in the last 2 years

  • History of bleeding disorder including rectal bleeding (ie, hemorrhoids), spontaneous nosebleeds, etc.

Other protocol defined inclusion / exclusion criteria could apply

Contacts and Locations

Locations

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

Sponsors and Collaborators

  • Bristol-Myers Squibb

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT03362437
Other Study ID Numbers:
  • CV010-020
First Posted:
Dec 5, 2017
Last Update Posted:
Mar 14, 2018
Last Verified:
Mar 1, 2018
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Thrombosis

Study Results

No Results Posted as of Mar 14, 2018