An Investigational Study to Evaluate Experimental Medication BMS-986036 in Participants With Different Levels of Kidney Function

NAFLD Clinical Trial

Official title:

A Phase 1, Open-Label, Parallel-Group, Single-Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of BMS-986036 in Participants With Varying Degrees of Renal Function

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03674476
• Other study ID #: MB130-065
• Secondary ID: 2018-001497-19
• Status: Completed
• Phase: Phase 1
• Start date: September 11, 2018
• Est. completion date: June 24, 2019

Study information

• Verified date: October 2019
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is an investigational study to evaluate the experimental medication BMS-986036 in participants with different levels of kidney function.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 24, 2019
• Est. primary completion date: June 24, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 75 Years

Eligibility

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

Inclusion Criteria:

• BMI = 25 and = 40 kg/m2

Exclusion Criteria:

• Presence of any factors that would predispose the participant to infection (eg, extensive periodontal disease that warrants surgical or medical treatment, unhealed open wounds)

• Any bone trauma (fracture) or bone surgery (ie, hardware placement, joint replacement, bone grafting, or amputation) within 3 months of study drug administration

• Any history of known or suspected congenital or acquired immunodeficiency state or condition that would compromise the participant's immune status

• Any major surgery (eg, abdominal, thoracal, or cranial procedures) within 6 weeks of study drug administration

• Donation of blood or plasma to a blood bank, or in a clinical study (except at the screening visit) within 6 weeks of study drug administration

• Inability to tolerate subcutaneous injections

Other protocol defined inclusion/exclusion criteria could apply

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• NAFLD
• Non-alcoholic Fatty Liver Disease
• Nonalcoholic Fatty Liver Disease
• Nonalcoholic Steatohepatitis

Intervention

Drug:
• BMS-986036
Specified dose on specified days

Locations

Country	Name	City	State
Czechia	Pharmaceutical Research Associates CZ, s.r.o	Praha 7
Hungary	PRA Magyarorszag Kft	Budapest
Hungary	Semmelweis Egyetem	Budapest
Hungary	Clinical Research Unit Hungary	Miskolc

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

Czechia,  Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum observed serum concentration (Cmax) of C-terminal intact BMS-986036		Up to 30 days
Primary	Time of maximum observed serum concentration (Tmax) of C-terminal intact BMS-986036		Up to 30 days
Primary	Area under the serum concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] of C-terminal intact BMS-986036		Up to 30 days
Primary	Area under the serum concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of C-terminal intact BMS-986036		Up to 30 days
Primary	Terminal elimination half-life (T-half) of C-terminal intact BMS-986036		Up to 30 days
Primary	Apparent total body clearance (CLT/F) of C-terminal intact BMS-986036		Up to 30 days
Primary	Apparent volume of distribution (Vz/F) of C-terminal intact BMS-986036		Up to 30 days
Primary	Total renal clearance (CLR) of C-terminal intact BMS-986036		Up to 30 days
Primary	Amount per fraction excreted into urine (Fe) of C-terminal intact BMS-986036		Up to 30 days
Primary	Total amount excreted into urine (Ae) of C-terminal intact BMS-986036		Up to 30 days
Secondary	Maximum observed serum concentration (Cmax) of total BMS-986036		Up to 30 days
Secondary	Time of maximum observed serum concentration (Tmax) of total BMS-986036		Up to 30 days
Secondary	Area under the serum concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] of total BMS-986036		Up to 30 days
Secondary	Area under the serum concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of total BMS-986036		Up to 30 days
Secondary	Terminal elimination half-life (T-half) of total BMS-986036		Up to 30 days
Secondary	Apparent total body clearance (CLT/F) of total BMS-986036		Up to 30 days
Secondary	Apparent volume of distribution (Vz/F) of total BMS-986036		Up to 30 days
Secondary	Total renal clearance (CLR) of total BMS-986036		Up to 30 days
Secondary	Amount per fraction excreted into urine (Fe) of total BMS-986036		Up to 30 days
Secondary	Total amount excreted into urine (Ae) of total BMS-986036		Up to 30 days
Secondary	Incidence of injection site reactions (prospective)		Up to 30 days
Secondary	Incidence of adverse events (AE)		Up to 30 days
Secondary	Incidence of serious adverse events (SAE)		Up to 30 days
Secondary	Incidence of clinically significant changes to events of special interest	Events of special interest include injection site assessment, AEs leading to discontinuation, and deaths as well as AEs related to marked abnormalities in clinical laboratory tests, vital sign measurements, electrocardiogram (ECGs), and physical examinations	Up to 30 days

External Links

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