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OpenTrials
Completed

NCT Number: NCT03196206

Evaluate Pharmacokinetics and Safety of BMS-986177 in Participants With Normal Renal Function and With Moderate or Severe Renal Impairment

Assess the pharmacokinetics, safety, and tolerability of a single dose of BMS-986177 in participants with normal renal function and moderate to severe renal impairment.

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Key information

Conditions

Thrombosis Cardiovascular Diseases Embolism and Thrombosis Vascular Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Clinical Pharmacology Of Miami Inc., Miami, Florida, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants in Groups B and C will be classified by renal function by eGRF at screening and confirmed on Day -1
  • Participants in Group A will be healthy participants as determined by no significant deviations in normal medical and surgical history and assessments
  • Participants in Group A must have a body mass index of 18.0 to 32.0 kg/m2, inclusive
  • Females must be of non-childbearing potential

Exclusion criteria

  • Participants in Groups B and C cannot have an indwelling catheter for hemodialysis
  • Participants in Groups B and C cannot have had, nor be waiting for, an organ transplant

Other protocol defined inclusion and exclusion criteria could apply

Treatment and study plan

BMS-986177

Drug

Oral Suspension

Primary outcomes

  1. Maximum observed plasma concentration (Cmax)

    Time frame: Up to 5 days

    Measured by plasma concentration

  2. AUC from time zero to time of last quantifiable concentration (AUC (0-T))

    Time frame: Up to 5 days

    Summary measures of PK parameters

  3. AUC from time zero extrapolated to infinite time (AUC (INF))

    Time frame: Up to 5 days

    Summary measures of PK parameters

Secondary outcomes

  1. Incidence of Adverse Events (AEs)

    Time frame: Up to 5 days

    Safety and tolerability as measured by incidence of AEs

  2. Incidence of Serious Adverse Events ( SAEs)

    Time frame: Up to 30 days

    Safety and tolerability as measured by incidence of SAEs

  3. Change from baseline in electrocardiogram findings

    Time frame: Up to 5 days

    Measured by investigator assessment

  4. Change from baseline in physical examination findings

    Time frame: Up to 5 days

    Measured by investigator assessment

  5. Change from baseline in clinical laboratory test findings

    Time frame: Up to 5 days

    Measured by investigator assessment

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

An Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics and Safety of BMS- 986177 in Participants With Normal Renal Function and Participants With Moderate and Severe Renal Impairment

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jun 22, 2017
Registry last updated
Jun 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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