A Study to Evaluate the Bioavailability of BMS-986205

June 26, 2018 updated by: Bristol-Myers Squibb

A Study to Evaluate the Absolute Bioavailability of BMS-986205 Tablet Formulation

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

7

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Ruddington Fields
      • Nottingham, Ruddington Fields, United Kingdom, NG11 6JS
        • Quotient Clinical

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Absolute oral bioavailability (F)
Time Frame: Up to 15 days
Measured by plasma concentration
Up to 15 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurrence of adverse events (AEs)
Time Frame: Up to 15 days
Safety and tolerability as measured by incidence of AEs
Up to 15 days
Occurrence of serious adverse events (SAEs)
Time Frame: Up to 15 days
Safety and tolerability as measured by incidence of SAEs
Up to 15 days
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
Up to 15 days
Number of participants with vital sign measurement abnormalities
Time Frame: Up to 15 days
Up to 15 days
Number of participants with electrocardiogram abnormalities
Time Frame: Up to 15 days
Up to 15 days
Number of participants with physical examination abnormalities
Time Frame: Up to 15 days
Up to 15 days
Number of participants with clinical laboratory test abnormalities
Time Frame: Up to 15 days
Up to 15 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 4, 2018

Primary Completion (Actual)

February 16, 2018

Study Completion (Actual)

February 16, 2018

Study Registration Dates

First Submitted

December 12, 2017

First Submitted That Met QC Criteria

December 12, 2017

First Posted (Actual)

December 15, 2017

Study Record Updates

Last Update Posted (Actual)

June 28, 2018

Last Update Submitted That Met QC Criteria

June 26, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA017-060
  • 2017-003100-51 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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