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.

Healthy Volunteer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03890770
• Other study ID #: IM011-061
• Secondary ID: 2018-002533-38
• Status: Completed
• Phase: Phase 1
• Start date: April 4, 2019
• Est. completion date: February 13, 2020

Study information

• Verified date: March 2021
• 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 kidney function.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: February 13, 2020
• Est. primary completion date: February 7, 2020
• 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:

• 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

Related Conditions & MeSH terms

• Healthy Volunteer
• Renal Impairment
• Renal Insufficiency

Intervention

Drug:
• BMS-986165
Oral administration

Locations

Country	Name	City	State
Czechia	Pharmaceutical Research Associates CZ, s.r.o	Praha 7
Hungary	Szent Imre Egyetemi Oktatokorhaz	Budapest
Hungary	Kenezy Gyula Korhaz es Rendelointezet	Debrecen
Poland	Samodzielny Publiczny Secjalistyczny Szpital Zachodni im. sw. Jana Pawla II	Grodzisk Mazowiecki
Poland	Specjalistyczne Centrum Medyczne Chirurgii Maloinwazyjnej SCM	Krakow
United States	Orlando Clinical Research Center	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Czechia,  Hungary,  Poland, 

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 45 days
Secondary	Number of clinically significant changes in clinical laboratory values, vital signs, ECGs, and physical examinations		Approximately 45 days

External Links

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