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

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ClinicalTrials.gov Identifier: NCT03362437
Recruitment Status : Completed
First Posted : December 5, 2017
Last Update Posted : March 14, 2018
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

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
Thrombosis Drug: BMS-986177 Phase 1

Study Type : Interventional  (Clinical Trial)
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 : November 15, 2017
Actual Primary Completion Date : December 28, 2017
Actual Study Completion Date : December 28, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Clots

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




Primary Outcome Measures :
  1. Maximum observed plasma concentration (Cmax) [ Time Frame: Up to 3 days ]
    Measured by plasma concentration

  2. AUC from time zero to time of last quantifiable concentration (AUC(0-T)) [ Time Frame: Up to 3 days ]
    Measured by plasma concentration

  3. AUC from time zero extrapolated to infinite time (AUC(INF)) [ Time Frame: Up to 3 days ]
    Measured by plasma concentration


Secondary Outcome Measures :
  1. Incidence of Adverse Events (AEs) [ Time Frame: Up to 12 days ]
    Safety and tolerability as measured by incidence of AEs

  2. Incidence of Serious Adverse Events (SAEs) [ Time Frame: Up to 30 days ]
    Safety and tolerability as measured by incidence of SAEs

  3. Number of participants with electrocardiogram abnormalities [ Time Frame: Up to 12 days ]
  4. Number of participants with physical examination abnormalities [ Time Frame: Up to 12 days ]
  5. Number of participants with clinical laboratory abnormalities [ Time Frame: Up to 12 days ]


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

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


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): NCT03362437


Locations
United Kingdom
Quotient Clinical
Ruddington, Nottingham, United Kingdom, NG11 6JS
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Briston-Myers Squibb

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03362437     History of Changes
Other Study ID Numbers: CV010-020
First Posted: December 5, 2017    Key Record Dates
Last Update Posted: March 14, 2018
Last Verified: March 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases