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

• Sponsor: Bristol-Myers Squibb (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03890809
• Collaborator: (none)
• Enrollment: 32
• Locations: 4
• Arms: 4
• Actual Duration (Months): 9.1
• Patients Per Site: 8
• Patients Per Site Per Month: 0.9

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Liver Dysfunction; Healthy Volunteers	Drug: BMS-986165	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 32 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Feb 26, 2019
• Actual Primary Completion Date: Nov 30, 2019
• Actual Study Completion Date: Nov 30, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Normal liver function Single dose	Drug: BMS-986165; Oral administration
Experimental: Mild liver impairment Single dose	Drug: BMS-986165; Oral administration
Experimental: Moderate liver impairment Single dose	Drug: BMS-986165; Oral administration
Experimental: Severe liver impairment Single dose	Drug: BMS-986165; Oral administration

Outcome Measures

Primary Outcome Measures

1. Maximum observed plasma concentration (Cmax) [Approximately 9 days]

2. Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration [AUC(0-T)] [Approximately 9 days]

3. Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] [Approximately 9 days]

Secondary Outcome Measures

1. Incidence of nonserious adverse events (AE), serious adverse events (SAE), and AE leading to discontinuation [Approximately 44 days]

2. Number of clinically significant changes in clinical laboratory values, vital signs, ECGs, and physical examinations [Approximately 44 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pharmaceutical Research Associates CZ, s.r.o	Praha 7		Czechia	170 00
2	Kenezy Gyula Korhaz es Rendelointezet	Debrecen		Hungary	4043
3	Clinical Research Unit Hungary	Miskolc		Hungary	3529
4	Local Institution	Bratislava		Slovakia	831 01

Sponsors and Collaborators

• Bristol-Myers Squibb

Investigators

• Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

None provided.

• Responsible Party: Bristol-Myers Squibb
• ClinicalTrials.gov Identifier: NCT03890809
• Other Study ID Numbers: IM011-062; 2018-002534-20
• First Posted: Mar 26, 2019
• Last Update Posted: Aug 26, 2020
• Last Verified: Aug 1, 2020

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes
• Additional relevant MeSH terms: Liver Diseases; BMS-986165

Study Results

No Results Posted as of Aug 26, 2020