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

Thrombosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03196206
• Other study ID #: CV010-018
• Status: Completed
• Phase: Phase 1
• Start date: July 13, 2017
• Est. completion date: March 4, 2018

Study information

• Verified date: June 2022
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: March 4, 2018
• Est. primary completion date: March 4, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Thrombosis

Intervention

Drug:
• BMS-986177
Oral Suspension

Locations

Country	Name	City	State
United States	Clinical Pharmacology Of Miami Inc.	Miami	Florida
United States	Clinical Pharmacology of Miami LLC	Miami	Florida
United States	Orlando Clinical Research Center	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum observed plasma concentration (Cmax)	Measured by plasma concentration	Up to 5 days
Primary	AUC from time zero to time of last quantifiable concentration (AUC (0-T))	Summary measures of PK parameters	Up to 5 days
Primary	AUC from time zero extrapolated to infinite time (AUC (INF))	Summary measures of PK parameters	Up to 5 days
Secondary	Incidence of Adverse Events (AEs)	Safety and tolerability as measured by incidence of AEs	Up to 5 days
Secondary	Incidence of Serious Adverse Events ( SAEs)	Safety and tolerability as measured by incidence of SAEs	Up to 30 days
Secondary	Change from baseline in electrocardiogram findings	Measured by investigator assessment	Up to 5 days
Secondary	Change from baseline in physical examination findings	Measured by investigator assessment	Up to 5 days
Secondary	Change from baseline in clinical laboratory test findings	Measured by investigator assessment	Up to 5 days

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting
•   FDA Safety Alerts and Recalls
•   Investigator Inquiry Form