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

Phase 1

Completed

• Conditions: Healthy Volunteers; Liver Dysfunction
• Interventions: Drug: BMS-986165

• Registration Number: NCT03890809
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2019-02-26
• Study First Submitted: 2019-03-25
• Study First Submitted QC: 2019-03-25
• Study First Posted: 2019-03-26
• Primary Completion: 2019-11-30
• Study Completion: 2019-11-30
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-24
• Last Update Posted: 2020-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Severe liver impairment	BMS-986165	Single dose
Mild liver impairment	BMS-986165	Single dose
Normal liver function	BMS-986165	Single dose
Moderate liver impairment	BMS-986165	Single dose

Primary Outcome Measures

Name	Time	Method
Maximum observed plasma concentration (Cmax)	Approximately 9 days
Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration [AUC(0-T)]	Approximately 9 days
Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)]	Approximately 9 days

Secondary Outcome Measures

Name	Time	Method
Incidence of nonserious adverse events (AE), serious adverse events (SAE), and AE leading to discontinuation	Approximately 44 days
Number of clinically significant changes in clinical laboratory values, vital signs, ECGs, and physical examinations	Approximately 44 days

Trial Locations

Locations (4)

Kenezy Gyula Korhaz es Rendelointezet; 🇭🇺 Debrecen, Hungary

Clinical Research Unit Hungary; 🇭🇺 Miskolc, Hungary

Pharmaceutical Research Associates CZ, s.r.o; 🇨🇿 Praha 7, Czechia

Local Institution; 🇸🇰 Bratislava, Slovakia