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

Primary Purpose

Thrombosis

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

BMS-986177

About this trial

This is an interventional other trial for Thrombosis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Clinical Pharmacology Of Miami Inc.
Clinical Pharmacology of Miami LLC
Orlando Clinical Research Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Group A

Group B

Group C

Arm Description

Normal Renal Function

Moderate Renal Impairment

Severe Renal Impairment

Outcomes

Primary Outcome Measures

Maximum observed plasma concentration (Cmax)

Measured by plasma concentration

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

Summary measures of PK parameters

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

Summary measures of PK parameters

Secondary Outcome Measures

Incidence of Adverse Events (AEs)

Safety and tolerability as measured by incidence of AEs

Incidence of Serious Adverse Events ( SAEs)

Safety and tolerability as measured by incidence of SAEs

Change from baseline in electrocardiogram findings

Measured by investigator assessment

Change from baseline in physical examination findings

Measured by investigator assessment

Change from baseline in clinical laboratory test findings

Measured by investigator assessment

Full Information

NCT ID

NCT03196206

First Posted

June 21, 2017

Last Updated

June 8, 2022

Sponsor

Bristol-Myers Squibb

1. Study Identification

Unique Protocol Identification Number

NCT03196206

Brief Title

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

Official 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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2022

Overall Recruitment Status

Completed

Study Start Date

July 13, 2017 (Actual)

Primary Completion Date

March 4, 2018 (Actual)

Study Completion Date

March 4, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bristol-Myers Squibb

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Thrombosis

7. Study Design

Primary Purpose

Other

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group A

Arm Type

Experimental

Arm Description

Normal Renal Function

Arm Title

Group B

Arm Type

Experimental

Arm Description

Moderate Renal Impairment

Arm Title

Group C

Arm Type

Experimental

Arm Description

Severe Renal Impairment

Intervention Type

Drug

Intervention Name(s)

BMS-986177

Intervention Description

Oral Suspension

Primary Outcome Measure Information:

Title

Maximum observed plasma concentration (Cmax)

Description

Measured by plasma concentration

Time Frame

Up to 5 days

Title

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

Description

Summary measures of PK parameters

Time Frame

Up to 5 days

Title

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

Description

Summary measures of PK parameters

Time Frame

Up to 5 days

Secondary Outcome Measure Information:

Title

Incidence of Adverse Events (AEs)

Description

Safety and tolerability as measured by incidence of AEs

Time Frame

Up to 5 days

Title

Incidence of Serious Adverse Events ( SAEs)

Description

Safety and tolerability as measured by incidence of SAEs

Time Frame

Up to 30 days

Title

Change from baseline in electrocardiogram findings

Description

Measured by investigator assessment

Time Frame

Up to 5 days

Title

Change from baseline in physical examination findings

Description

Measured by investigator assessment

Time Frame

Up to 5 days

Title

Change from baseline in clinical laboratory test findings

Description

Measured by investigator assessment

Time Frame

Up to 5 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bristol-Myers Squibb

Organizational Affiliation

Bristol-Myers Squibb

Official's Role

Study Director

Facility Information:

Facility Name

Clinical Pharmacology Of Miami Inc.

City

Miami

State/Province

Florida

ZIP/Postal Code

33014

Country

United States

Facility Name

Clinical Pharmacology of Miami LLC

City

Miami

State/Province

Florida

ZIP/Postal Code

33014

Country

United States

Facility Name

Orlando Clinical Research Center

City

Orlando

State/Province

Florida

ZIP/Postal Code

32809

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

35906349

Citation

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.

Results Reference

derived

Links:

URL

https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

Description

BMS Clinical Trial Information

URL

https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm

Description

FDA Safety Alerts and Recalls

URL

http://bms.com/studyconnect/Pages/home.aspx

Description

BMS Clinical Trial Patient Recruiting

URL

https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

Description

Investigator Inquiry Form

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