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An Investigational Study of BMS-986165 in Participants With Normal Liver Function and Participants With Mild to Severe Liver Damage

Primary Purpose

Liver Dysfunction, Healthy Volunteers

Status

Completed

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

BMS-986165

About this trial

This is an interventional treatment trial for Liver Dysfunction

Eligibility Criteria

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

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

Body mass index of 18.0 to 38.0 kg/m2, inclusive, and weight ≥ 50 kg, at screening
Normal renal function at screening as evidenced by an estimated glomerular filtration rate (GFR) > 80 mL/min/1.73 m2 for participants

Exclusion Criteria:

Clinically relevant abnormal medical history, abnormal findings on physical examination, vital signs, ECG, or laboratory tests at screening that the investigator judges as likely to interfere with the objectives of the trial or the safety of the participant
History or clinical evidence of acute or chronic bacterial infection (eg, pneumonia, septicemia) within 3 months prior to screening
Have a history of cancer (malignancy) with the following exceptions: (1) participants with adequately treated non-melanomatous skin carcinoma or carcinoma in situ of the cervix may participate in the trial; (2) participants with other malignancies who have been successfully treated ≥10 years prior to the screening visit where, in the judgment of both the investigator and treating physician, appropriate follow-up has revealed no evidence of recurrence from the time of treatment through the time of the screening visit

Other protocol defined inclusion/exclusion criteria could apply

Sites / Locations

Pharmaceutical Research Associates CZ, s.r.o
Kenezy Gyula Korhaz es Rendelointezet
Clinical Research Unit Hungary
Local Institution

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

Normal liver function

Mild liver impairment

Moderate liver impairment

Severe liver impairment

Arm Description

Single dose

Outcomes

Primary Outcome Measures

Maximum observed plasma concentration (Cmax)

Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration [AUC(0-T)]

Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)]

Secondary Outcome Measures

Incidence of nonserious adverse events (AE), serious adverse events (SAE), and AE leading to discontinuation

Number of clinically significant changes in clinical laboratory values, vital signs, ECGs, and physical examinations

Full Information

NCT ID

NCT03890809

First Posted

March 25, 2019

Last Updated

August 24, 2020

Sponsor

Bristol-Myers Squibb

1. Study Identification

Unique Protocol Identification Number

NCT03890809

Brief Title

An Investigational Study of BMS-986165 in Participants With Normal Liver Function and Participants With Mild to Severe Liver Damage

Official Title

An Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics and Safety of BMS-986165 in Participants With Normal Hepatic Function and Participants With Mild, Moderate and Severe Hepatic Impairment

Study Type

Interventional

2. Study Status

Record Verification Date

August 2020

Overall Recruitment Status

Completed

Study Start Date

February 26, 2019 (Actual)

Primary Completion Date

November 30, 2019 (Actual)

Study Completion Date

November 30, 2019 (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

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to investigate BMS-986165 in participants with different levels of liver function.

6. Conditions and Keywords

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

Liver Dysfunction, Healthy Volunteers

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

32 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Normal liver function

Arm Type

Experimental

Arm Description

Single dose

Arm Title

Mild liver impairment

Arm Type

Experimental

Arm Description

Single dose

Arm Title

Moderate liver impairment

Arm Type

Experimental

Arm Description

Single dose

Arm Title

Severe liver impairment

Arm Type

Experimental

Arm Description

Single dose

Intervention Type

Drug

Intervention Name(s)

BMS-986165

Intervention Description

Oral administration

Primary Outcome Measure Information:

Title

Maximum observed plasma concentration (Cmax)

Time Frame

Approximately 9 days

Title

Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration [AUC(0-T)]

Time Frame

Approximately 9 days

Title

Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)]

Time Frame

Approximately 9 days

Secondary Outcome Measure Information:

Title

Incidence of nonserious adverse events (AE), serious adverse events (SAE), and AE leading to discontinuation

Time Frame

Approximately 44 days

Title

Number of clinically significant changes in clinical laboratory values, vital signs, ECGs, and physical examinations

Time Frame

Approximately 44 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: Body mass index of 18.0 to 38.0 kg/m2, inclusive, and weight ≥ 50 kg, at screening Normal renal function at screening as evidenced by an estimated glomerular filtration rate (GFR) > 80 mL/min/1.73 m2 for participants Exclusion Criteria: Clinically relevant abnormal medical history, abnormal findings on physical examination, vital signs, ECG, or laboratory tests at screening that the investigator judges as likely to interfere with the objectives of the trial or the safety of the participant History or clinical evidence of acute or chronic bacterial infection (eg, pneumonia, septicemia) within 3 months prior to screening Have a history of cancer (malignancy) with the following exceptions: (1) participants with adequately treated non-melanomatous skin carcinoma or carcinoma in situ of the cervix may participate in the trial; (2) participants with other malignancies who have been successfully treated ≥10 years prior to the screening visit where, in the judgment of both the investigator and treating physician, appropriate follow-up has revealed no evidence of recurrence from the time of treatment through the time of the screening visit Other protocol defined inclusion/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

Pharmaceutical Research Associates CZ, s.r.o

City

Praha 7

ZIP/Postal Code

170 00

Country

Czechia

Facility Name

Kenezy Gyula Korhaz es Rendelointezet

City

Debrecen

ZIP/Postal Code

4043

Country

Hungary

Facility Name

Clinical Research Unit Hungary

City

Miskolc

ZIP/Postal Code

3529

Country

Hungary

Facility Name

Local Institution

City

Bratislava

ZIP/Postal Code

831 01

Country

Slovakia

12. IPD Sharing Statement

Links:

URL

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

Description

BMS Clinical Trial Information

URL

https://www.bmsstudyconnect.com/s/US/English/USenHome

Description

BMS Clinical Trial Patient Recruiting

URL

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

Description

FDA Safety Alerts and Recalls

Learn more about this trial

An Investigational Study of BMS-986165 in Participants With Normal Liver Function and Participants With Mild to Severe Liver Damage

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