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Evaluate the Bioavailability Between 2 BMS-986141 Formulations in Healthy Participants

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ClinicalTrials.gov Identifier: NCT03035734
Recruitment Status : Withdrawn (Business objectives have changed)
First Posted : January 30, 2017
Last Update Posted : March 23, 2018
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
Open label, randomized, 4-period crossover study with single doses of BMS-986141 given to healthy female subjects of non-childbearing potential and healthy males.

Condition or disease Intervention/treatment Phase
Healthy Drug: BMS-986141 Form A Tablet Drug: BMS-986141 Form B tablet (low dose) Drug: BMS-986141 Form B tablet (high dose) Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Study to Evaluate the Bioavailability of BMS-986141 From a Form B Tablet Formulation Relative to the Form A Reference Tablet in Healthy Participants
Actual Study Start Date : January 25, 2017
Actual Primary Completion Date : February 7, 2017
Actual Study Completion Date : February 7, 2017

Arm Intervention/treatment
Active Comparator: A
Single oral dose BMS-986141 Form A tablet under fasting conditions
Drug: BMS-986141 Form A Tablet
tablet

Experimental: B
Single oral dose BMS-986141 Form B tablet (low-dose) under fasting conditions
Drug: BMS-986141 Form B tablet (low dose)
tablet

Experimental: C
Single oral dose BMS-986141 Form B tablet (high-dose) under fasting conditions
Drug: BMS-986141 Form B tablet (high dose)
tablet

Experimental: D
Single oral dose BMS-986141 Form B tablet (high-dose) under fed conditions
Drug: BMS-986141 Form B tablet (high dose)
tablet




Primary Outcome Measures :
  1. Evaluate the bioavailability between BMS-986141 Form B tablet compared to the Form A reference tablet [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. Further characterize safety and tolerability of BMS-986141 by assessing adverse events and other physical assessments throughout study conduct [ Time Frame: 4 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy participants as determined by no significant deviations in normal medical and surgical history and assessments
  • Body mass index 18.0 kg/m2 to 32.0 kg/m2
  • females must be of non-childbearing potential

Exclusion Criteria:

  • known bleeding or coagulation disorders
  • acute or chronic medical illness
  • history of nausea or chronic diarrhea that lasts over 4 weeks
  • history of periodontal disease or gingivitis which required treatment
  • other exclusion criteria may 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): NCT03035734


Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03035734     History of Changes
Other Study ID Numbers: CV006-023
2016-001031-13 ( EudraCT Number )
First Posted: January 30, 2017    Key Record Dates
Last Update Posted: March 23, 2018
Last Verified: March 2018

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