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CompletedNCT03196206Updated Jun 10, 2022

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

A Phase 1 interventional study of BMS-986177 in Thrombosis, sponsored by Bristol-Myers Squibb. Completed at 3 sites in United States. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-06-10.

Sponsored by Bristol-Myers Squibb · Phase 1, Interventional, and Other

From the registry’s dates

  • Primary completion was Mar 2018, 8 years 7 months ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
24
Allocation
Non-randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Thrombosis

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03

In context

Thrombosis

1,506 studies on the registry are indexed under Thrombosis; 238 are open to participants now.

This study's enrollment of 24 is below the median of 106 across 849 interventional studies indexed under Thrombosis.

Browse Thrombosis studies →

Lead sponsor

Bristol-Myers Squibb is the lead sponsor of 1,538 studies on the registry; 116 are open to participants now.

Of its 429 completed or terminated interventional studies of FDA-regulated products, 223 (52%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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

05

Study design

Phase
Phase 1
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
24 participants (actual)

Study arms

  • Experimental
    Group A

    Normal Renal Function

    Drug: BMS-986177

  • Experimental
    Group B

    Moderate Renal Impairment

    Drug: BMS-986177

  • Experimental
    Group C

    Severe Renal Impairment

    Drug: BMS-986177

Interventions

  • DrugBMS-986177

    Oral Suspension

06

What researchers measure

Primary outcomes

  1. Maximum observed plasma concentration (Cmax)

    Measured by plasma concentration

    Time frame: Up to 5 days

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

    Summary measures of PK parameters

    Time frame: Up to 5 days

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

    Summary measures of PK parameters

    Time frame: Up to 5 days

Secondary outcomes

  1. Incidence of Adverse Events (AEs)

    Safety and tolerability as measured by incidence of AEs

    Time frame: Up to 5 days

  2. Incidence of Serious Adverse Events ( SAEs)

    Safety and tolerability as measured by incidence of SAEs

    Time frame: Up to 30 days

  3. Change from baseline in electrocardiogram findings

    Measured by investigator assessment

    Time frame: Up to 5 days

  4. Change from baseline in physical examination findings

    Measured by investigator assessment

    Time frame: Up to 5 days

  5. Change from baseline in clinical laboratory test findings

    Measured by investigator assessment

    Time frame: Up to 5 days

07

Study locations

3 sites
  • Clinical Pharmacology Of Miami Inc.
    Miami, Florida 33014, United States
  • Clinical Pharmacology of Miami LLC
    Miami, Florida 33014, United States
  • Orlando Clinical Research Center
    Orlando, Florida 32809, United States
08

References and documents

Publications

  • Perera V, Abelian G, Li D, Wang Z, Zhang L, Lubin S, Bello A, Murthy B. Single-Dose Pharmacokinetics of Milvexian in Participants with Normal Renal Function and Participants with Moderate or Severe Renal Impairment. Clin Pharmacokinet. 2022 Oct;61(10):1405-1416. doi: 10.1007/s40262-022-01150-1. Epub 2022 Jul 30. PubMed 35906349 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 10, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03196206
Lead sponsor
Bristol-Myers Squibb
Responsible party
Sponsor
First posted
Jun 22, 2017
Start date
Jul 13, 2017
Primary completion
Mar 4, 2018
Completion
Mar 4, 2018
Last update
Jun 10, 2022

Study contacts

Bristol-Myers Squibb
study director · Bristol-Myers Squibb

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.

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