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

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03890809
• Other study ID #: IM011-062
• Secondary ID: 2018-002534-20
• Status: Completed
• Phase: Phase 1
• Start date: February 26, 2019
• Est. completion date: November 30, 2019

Study information

• Verified date: August 2020
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: November 30, 2019
• Est. primary completion date: November 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers
• Liver Diseases
• Liver Dysfunction

Intervention

Drug:
• BMS-986165
Oral administration

Locations

Country	Name	City	State
Czechia	Pharmaceutical Research Associates CZ, s.r.o	Praha 7
Hungary	Kenezy Gyula Korhaz es Rendelointezet	Debrecen
Hungary	Clinical Research Unit Hungary	Miskolc
Slovakia	Local Institution	Bratislava

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

Czechia,  Hungary,  Slovakia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum observed plasma concentration (Cmax)		Approximately 9 days
Primary	Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration [AUC(0-T)]		Approximately 9 days
Primary	Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)]		Approximately 9 days
Secondary	Incidence of nonserious adverse events (AE), serious adverse events (SAE), and AE leading to discontinuation		Approximately 44 days
Secondary	Number of clinically significant changes in clinical laboratory values, vital signs, ECGs, and physical examinations		Approximately 44 days

External Links

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