NCT03374228

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jan 2018

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 12, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 15, 2017

Completed
20 days until next milestone

Study Start

First participant enrolled

January 4, 2018

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 16, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 16, 2018

Completed
Last Updated

June 28, 2018

Status Verified

June 1, 2018

Enrollment Period

1 month

First QC Date

December 12, 2017

Last Update Submit

June 26, 2018

Conditions

Healthy Participants

Outcome Measures

Primary Outcomes (1)

  • Absolute oral bioavailability (F)

    Measured by plasma concentration

    Up to 15 days

Secondary Outcomes (7)

  • Occurrence of adverse events (AEs)

    Up to 15 days

  • Occurrence of serious adverse events (SAEs)

    Up to 15 days

  • Occurrence of adverse events (AEs) leading to discontinuation

    Up to 15 days

  • Number of participants with vital sign measurement abnormalities

    Up to 15 days

  • Number of participants with electrocardiogram abnormalities

    Up to 15 days

  • +2 more secondary outcomes

Study Arms (1)

BMS-986205

EXPERIMENTAL

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

Interventions

BMS-986205DRUG

Specified Dose on Specified Days

BMS-986205

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Quotient Clinical

Nottingham, Ruddington Fields, NG11 6JS, United Kingdom

Location

Related Links

MeSH Terms

Interventions

linrodostat

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 12, 2017

First Posted

December 15, 2017

Study Start

January 4, 2018

Primary Completion

February 16, 2018

Study Completion

February 16, 2018

Last Updated

June 28, 2018

Record last verified: 2018-06

Locations

GB(1)