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A Study to Evaluate the Bioavailability of BMS-986205

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03374228
Recruitment Status : Completed
First Posted : December 15, 2017
Last Update Posted : June 28, 2018
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Description
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Brief Summary:
Assess the absolute bioavailability of a tablet formulation of BMS-986205 following simultaneous oral administration of BMS-986205 and intravenous infusion of [13C]BMS-986205 solution for intravenous administration in healthy participants.

Condition or disease Intervention/treatment Phase
Healthy Participants Drug: BMS-986205 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Study to Evaluate the Absolute Bioavailability of BMS-986205 Tablet Formulation
Actual Study Start Date : January 4, 2018
Actual Primary Completion Date : February 16, 2018
Actual Study Completion Date : February 16, 2018
Arms and Interventions
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Arm Intervention/treatment
Experimental: BMS-986205
Single oral dose of BMS-986205 tablet on the morning of Day 1 followed by a 15-minute infusion of [13C]BMS-986205 solution for intravenous administration starting 01:45 hours after the oral dose administration
 Drug: BMS-986205
Specified Dose on Specified Days


Outcome Measures
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Primary Outcome Measures :
  1. Absolute oral bioavailability (F) [ Time Frame: Up to 15 days ]
    Measured by plasma concentration


Secondary Outcome Measures :
  1. Occurrence of adverse events (AEs) [ Time Frame: Up to 15 days ]
    Safety and tolerability as measured by incidence of AEs

  2. Occurrence of serious adverse events (SAEs) [ Time Frame: Up to 15 days ]
    Safety and tolerability as measured by incidence of SAEs

  3. Occurrence of adverse events (AEs) leading to discontinuation [ Time Frame: Up to 15 days ]
    Safety and tolerability as measured by incidence of AEs leading to discontinuation

  4. Number of participants with vital sign measurement abnormalities [ Time Frame: Up to 15 days ]
  5. Number of participants with electrocardiogram abnormalities [ Time Frame: Up to 15 days ]
  6. Number of participants with physical examination abnormalities [ Time Frame: Up to 15 days ]
  7. Number of participants with clinical laboratory test abnormalities [ Time Frame: Up to 15 days ]

Eligibility Criteria
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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:

  • Body mass index (BMI) 18.0 to 32.0 kg/m2, inclusive
  • Must have normal renal function demonstrated by an estimated glomerular filtration rate, calculated by Chronic Kidney Disease Epidemiology Collaboration formula
  • Women must not be of childbearing potential (cannot become pregnant)

Exclusion Criteria:

  • Women who are of childbearing potential or breastfeeding
  • Any significant acute or chronic medical illness
  • Active tuberculosis (TB) requiring treatment or documented latent TB at screening

Other protocol defined inclusion / exclusion criteria could apply

Contacts and Locations
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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): NCT03374228


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

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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03374228    
Other Study ID Numbers: CA017-060
2017-003100-51 ( EudraCT Number )
First Posted: December 15, 2017    Key Record Dates
Last Update Posted: June 28, 2018
Last Verified: June 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Linrodostat
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action