CompletedNCT03890809Updated Aug 26, 2020

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

A Phase 1 interventional study of BMS-986165 in Liver Dysfunction and Healthy Volunteers, sponsored by Bristol-Myers Squibb. Completed at 4 sites in 3 countries. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-08-26.

Sponsored by Bristol-Myers Squibb · Phase 1, Interventional, and Treatment

From the registry’s dates

Primary completion was Nov 2019, 6 years 10 months ago, and no results have been posted to the registry.

Phase: Phase 1
Study type: Interventional
Enrollment: 32
Allocation: Non-randomized
Ages: 18 Years to 70 Years
Sex: All

Study summary

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

Conditions studied

Liver Dysfunction
Healthy Volunteers

Browse trials for

Liver Diseases 2,081

In context

Liver Diseases

2,081 studies on the registry are indexed under Liver Diseases; 390 are open to participants now.

This study's enrollment of 32 is below the median of 50 across 1,323 interventional studies indexed under Liver Diseases.

Browse Liver Diseases studies →

Lead sponsor

Bristol-Myers Squibb is the lead sponsor of 1,538 studies on the registry; 116 are open to participants now.

Of its 429 completed or terminated interventional studies of FDA-regulated products, 223 (52%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 70 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

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

Inclusion criteria

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

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

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomized
Intervention model: Single group
Masking: None (open label)
Enrollment: 32 participants (actual)

Study arms

Experimental
Normal liver function
Single dose
Drug: BMS-986165
Experimental
Mild liver impairment
Single dose
Drug: BMS-986165
Experimental
Moderate liver impairment
Single dose
Drug: BMS-986165
Experimental
Severe liver impairment
Single dose
Drug: BMS-986165

Interventions

DrugBMS-986165
Oral administration

What researchers measure

Primary outcomes

Maximum observed plasma concentration (Cmax)
Time frame: Approximately 9 days
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
Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)]
Time frame: Approximately 9 days

Secondary outcomes

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

Study locations

4 sites

Pharmaceutical Research Associates CZ, s.r.o
Praha 7, 170 00, Czechia
Kenezy Gyula Korhaz es Rendelointezet
Debrecen, 4043, Hungary
Clinical Research Unit Hungary
Miskolc, 3529, Hungary
Local Institution
Bratislava, 831 01, Slovakia

References and documents

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Aug 26, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03890809
Lead sponsor: Bristol-Myers Squibb
Responsible party: Sponsor
First posted: Mar 26, 2019
Start date: Feb 26, 2019
Primary completion: Nov 30, 2019
Completion: Nov 30, 2019
Last update: Aug 26, 2020

Study contacts

Bristol-Myers Squibb

study director · Bristol-Myers Squibb

Oversight

Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.

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