A Study to Assess the Safety of Experimental Medication BMS986165 in Participants With Normal Kidney Function and Participants With Mild to End-Stage Kidney Disease.

• Sponsor: Bristol-Myers Squibb (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03890770
• Collaborator: (none)
• Enrollment: 44
• Locations: 6
• Arms: 5
• Actual Duration (Months): 10.3
• Patients Per Site: 7.3
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Renal Impairment; Healthy Volunteer	Drug: BMS-986165	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 44 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel 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 Renal Function and Participants With Mild, Moderate, and Severe Renal Impairment and in Participants With End-Stage Renal Disease (ESRD) on Hemodialysis
• Actual Study Start Date: Apr 4, 2019
• Actual Primary Completion Date: Feb 7, 2020
• Actual Study Completion Date: Feb 13, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Normal renal function Single dose	Drug: BMS-986165; Oral administration
Experimental: Mild renal disease Single dose	Drug: BMS-986165; Oral administration
Experimental: Moderate renal failure Single dose	Drug: BMS-986165; Oral administration
Experimental: Severe renal failure Single dose	Drug: BMS-986165; Oral administration
Experimental: End-stage renal disease requiring dialysis Two single doses administered with washout	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 45 days]

2. Number of clinically significant changes in clinical laboratory values, vital signs, ECGs, and physical examinations [Approximately 45 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:

• Participants must be judged to be in good health in the opinion of the investigator OR participant has a stable disease (eg, hypertension, hyperlipidemia, diabetes mellitus, hyperthyreosis) under medical control (ie, no changes in medication within 30 days prior to study drug administration)

• Stable renal impairment, defined as no clinically significant change in disease status, as documented by the participant's most recent eGFR assessment; eGFR must not vary more than 30% from screening to Day -1 to confirm stable renal function, and the renal impairment must be expected by the investigator not to change significantly during the next 3 months

• Body mass index of 18.0 to 38.0 kg/m2, inclusive, and weight ≥50 kg, at screening

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

• Have a history of cancer (malignancy) with the following exceptions: (1) subjects with adequately treated non-melanomatous skin carcinoma or carcinoma in situ of the cervix may participate in the trial; (2) subjects with other malignancies that 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

• History or clinical evidence of acute or chronic bacterial infection (eg, pneumonia, septicemia) within 3 months prior to screening

Other protocol defined inclusion/exclusion criteria could apply

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Orlando Clinical Research Center	Orlando	Florida	United States	32809
2	Pharmaceutical Research Associates CZ, s.r.o	Praha 7		Czechia	170 00
3	Szent Imre Egyetemi Oktatokorhaz	Budapest		Hungary	1115
4	Kenezy Gyula Korhaz es Rendelointezet	Debrecen		Hungary	4043
5	Samodzielny Publiczny Secjalistyczny Szpital Zachodni im. sw. Jana Pawla II	Grodzisk Mazowiecki		Poland	05-825
6	Specjalistyczne Centrum Medyczne Chirurgii Maloinwazyjnej SCM	Krakow		Poland	31-559

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: NCT03890770
• Other Study ID Numbers: IM011-061; 2018-002533-38
• First Posted: Mar 26, 2019
• Last Update Posted: Mar 12, 2021
• Last Verified: Mar 1, 2021

• 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: Renal Insufficiency; BMS-986165

Study Results

No Results Posted as of Mar 12, 2021