NCT03378310

Brief Summary

This is a Phase 1, open-label, randomized study in healthy participants to evaluate the absorption of a BMS-986205 tablet into the bloodstream compared to a reference tablet. Eligible participants will be randomly assigned to 1 of 2 treatment sequences and will receive a single, oral dose of BMS-986205 twice over 22 days. Participants must remain at the clinical facility for the duration of the study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for phase_1 healthy-volunteers

Timeline
Completed

Started Dec 2017

Shorter than P25 for phase_1 healthy-volunteers

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 15, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 19, 2017

Completed
2 days until next milestone

Study Start

First participant enrolled

December 21, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2018

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 22, 2018

Completed
Last Updated

February 28, 2018

Status Verified

February 1, 2018

Enrollment Period

2 months

First QC Date

December 15, 2017

Last Update Submit

February 26, 2018

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (2)

  • Maximum observed plasma concentration (Cmax) of BMS-986205 tablet with free base compared to reference tablet.

    Measured by plasma concentration.

    Up to Day 22

  • Area under the plasma concentration time curve from time zero to 168 hours after dosing (AUC[0-168]) of BMS-986205 tablet with free base compared to reference tablet.

    Measured by plasma concentration.

    Up to Day 22

Secondary Outcomes (7)

  • Incidence of non-serious Adverse Events (AEs).

    Up to Day 22

  • Incidence of Serious Adverse Events (SAEs).

    Up to Day 22

  • Incidence of Adverse Events (AEs) leading to discontinuation.

    Up to Day 22

  • Number of participants with vital sign abnormalities.

    Up to Day 22

  • Number of participants with electrocardiogram (ECG) abnormalities.

    Up to Day 22

  • +2 more secondary outcomes

Study Arms (2)

Reference tablet followed by BMS-986205 tablet with free base

EXPERIMENTAL

BMS-986205 reference tablet (treatment period 1) followed by BMS-986205 tablet with free base (treatment period 2).

Drug: BMS-986205 reference tabletDrug: BMS-986205 tablet with free base

BMS-986205 tablet with free base followed by reference tablet

EXPERIMENTAL

BMS-986205 tablet with free base (treatment period 1) followed by BMS-986205 reference tablet (treatment period 2).

Drug: BMS-986205 reference tabletDrug: BMS-986205 tablet with free base

Interventions

BMS-986205 reference tabletDRUG

Single, 100 mg oral dose.

BMS-986205 tablet with free base followed by reference tabletReference tablet followed by BMS-986205 tablet with free base
BMS-986205 tablet with free baseDRUG

Single, 100 mg oral dose.

BMS-986205 tablet with free base followed by reference tabletReference tablet followed by BMS-986205 tablet with free base

Eligibility Criteria

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

You may qualify if:

  • Signed, written informed consent.
  • Healthy male and female participants (not of childbearing potential), determined by medical history, physical examination, electrocardiograms (ECGs) and clinical laboratory tests.
  • Normal renal (kidney) function.
  • Body Mass Index (BMI) of 18.0 kg/m2 to 32.0 kg/m2, inclusive.
  • Women must have documented proof they are not of childbearing potential.
  • Males who are sexually active with women of childbearing potential must agree to follow instructions for method(s) of contraception for the duration of treatment and 110 days after the last dose of BMS-986205. In addition, male participants must be willing to refrain from sperm donation during this time.

You may not qualify if:

  • Women of childbearing potential or breastfeeding.
  • Active tuberculosis (TB) requiring treatment or documented latent TB within the previous 3 years. Also excluded are participants with evidence of a past TB infection without documented adequate therapy.
  • History of pulmonary, renal, or liver disease; or of cardiac arrhythmias.
  • Recent (within 6 months of study drug administration) history of smoking or current smokers. This includes participants using electronic cigarettes or nicotine-containing products such as tobacco for chewing, nicotine patches, nicotine lozenges or nicotine gum.
  • Donation of blood to a blood bank or in a clinical study (except screening or follow-up visit) within 4 weeks of study drug administration (within 2 weeks for plasma only).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PPD Austin Clinic

Austin, Texas, 78744, United States

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
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 15, 2017

First Posted

December 19, 2017

Study Start

December 21, 2017

Primary Completion

February 15, 2018

Study Completion

February 22, 2018

Last Updated

February 28, 2018

Record last verified: 2018-02

Locations

US(1)