NCT03247283

Brief Summary

Phase 1 Phamacokinetic and metabolism study of BMS-986205 in healthy males

Trial Health

87
On Track

Trial Health Score

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

Enrollment
9

participants targeted

Target at below P25 for phase_1 cancer

Timeline
Completed

Started Jul 2017

Shorter than P25 for phase_1 cancer

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

Study Start

First participant enrolled

July 19, 2017

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

August 7, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 11, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2017

Completed
Last Updated

November 6, 2017

Status Verified

October 1, 2017

Enrollment Period

3 months

First QC Date

August 7, 2017

Last Update Submit

October 31, 2017

Conditions

Cancer

Outcome Measures

Primary Outcomes (6)

  • Area Under the Concentration-Time Curve from Time Zero to Time of Last Quantifiable Concentration (AUC[0-T])

    Measured by plasma concentrations

    up to 28 days

  • Percent of Total Radioactivity Recovered in All Excreta (% total)

    Measured by plasma urine, feces, and vomit (if applicable) volumes and radioactivity counts

    up to 28 days

  • Half-Life (T-HALF)

    Measured by plasma concentrations

    up to 28 days

  • Total Body Clearance (CLT)

    Measured by plasma concentrations

    up to 28 days

  • Volume of Distribution during Terminal Elimination Phase (Vz/F)

    Measured by plasma concentrations

    up to 28 days

  • Time to Maximum Observed Concentration (Tmax)

    Measured by plasma concentrations

    up to 28 days

Secondary Outcomes (4)

  • Incidence of adverse events (AEs)

    up to 28 days

  • Results of electrocardiogram tests (ECGs)

    up to 28 days

  • Results of vital sign measurements

    up to 28 days

  • Results of clinical laboratory tests

    up to 28 days

Study Arms (1)

Single Oral Dose of BMS-986205

EXPERIMENTAL
Drug: BMS-986205

Interventions

BMS-986205DRUG

Carbon 14 tagged BMS-986205

Single Oral Dose of BMS-986205

Eligibility Criteria

Age18 Years - 50 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsMale inclusion only
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Body weight 75-95kg, BMI 18.0-32.0 kg/m\^2
  • Refrain from sperm donation 110 days after dosing

You may not qualify if:

  • Current or recent gastrointestinal disease
  • Any GI surgery that could impact drug absorption
  • Active, known, or suspected autoimmune disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Covance Clinical Research Unit, Inc.

Madison, Wisconsin, 53704, United States

Location

Related Links

MeSH Terms

Conditions

Neoplasms

Interventions

linrodostat

Study Officials

  • Bristol- Myers Squibb

    Bristol-Myers Squibb

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

August 7, 2017

First Posted

August 11, 2017

Study Start

July 19, 2017

Primary Completion

October 15, 2017

Study Completion

October 15, 2017

Last Updated

November 6, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)