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

Primary Purpose

NAFLD, Nonalcoholic Fatty Liver Disease, Nonalcoholic Steatohepatitis

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
BMS-986036
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for NAFLD

Eligibility Criteria

21 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Pharmaceutical Research Associates CZ, s.r.o
  • PRA Magyarorszag Kft
  • Semmelweis Egyetem
  • Clinical Research Unit Hungary

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Other

Arm Label

Mild Renal Impairment

Moderate Renal Impairment

Severe Renal Impairment

Normal

Arm Description

The renal function will be defined by estimated glomerular filtration rate (eGFR) at Screening.

The renal function will be defined by estimated glomerular filtration rate (eGFR) at Screening.

The renal function will be defined by estimated glomerular filtration rate (eGFR) at Screening.

The renal function will be defined by estimated glomerular filtration rate (eGFR) at Screening.

Outcomes

Primary Outcome Measures

Maximum observed serum concentration (Cmax) of C-terminal intact BMS-986036
Time of maximum observed serum concentration (Tmax) of C-terminal intact BMS-986036
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
Area under the serum concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of C-terminal intact BMS-986036
Terminal elimination half-life (T-half) of C-terminal intact BMS-986036
Apparent total body clearance (CLT/F) of C-terminal intact BMS-986036
Apparent volume of distribution (Vz/F) of C-terminal intact BMS-986036
Total renal clearance (CLR) of C-terminal intact BMS-986036
Amount per fraction excreted into urine (Fe) of C-terminal intact BMS-986036
Total amount excreted into urine (Ae) of C-terminal intact BMS-986036

Secondary Outcome Measures

Maximum observed serum concentration (Cmax) of total BMS-986036
Time of maximum observed serum concentration (Tmax) of total BMS-986036
Area under the serum concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] of total BMS-986036
Area under the serum concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of total BMS-986036
Terminal elimination half-life (T-half) of total BMS-986036
Apparent total body clearance (CLT/F) of total BMS-986036
Apparent volume of distribution (Vz/F) of total BMS-986036
Total renal clearance (CLR) of total BMS-986036
Amount per fraction excreted into urine (Fe) of total BMS-986036
Total amount excreted into urine (Ae) of total BMS-986036
Incidence of injection site reactions (prospective)
Incidence of adverse events (AE)
Incidence of serious adverse events (SAE)
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

Full Information

First Posted
August 29, 2018
Last Updated
October 4, 2019
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT03674476
Brief Title
An Investigational Study to Evaluate Experimental Medication BMS-986036 in Participants With Different Levels of Kidney Function
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
September 11, 2018 (Actual)
Primary Completion Date
June 24, 2019 (Actual)
Study Completion Date
June 24, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

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

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
NAFLD, Nonalcoholic Fatty Liver Disease, Nonalcoholic Steatohepatitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mild Renal Impairment
Arm Type
Experimental
Arm Description
The renal function will be defined by estimated glomerular filtration rate (eGFR) at Screening.
Arm Title
Moderate Renal Impairment
Arm Type
Experimental
Arm Description
The renal function will be defined by estimated glomerular filtration rate (eGFR) at Screening.
Arm Title
Severe Renal Impairment
Arm Type
Experimental
Arm Description
The renal function will be defined by estimated glomerular filtration rate (eGFR) at Screening.
Arm Title
Normal
Arm Type
Other
Arm Description
The renal function will be defined by estimated glomerular filtration rate (eGFR) at Screening.
Intervention Type
Drug
Intervention Name(s)
BMS-986036
Intervention Description
Specified dose on specified days
Primary Outcome Measure Information:
Title
Maximum observed serum concentration (Cmax) of C-terminal intact BMS-986036
Time Frame
Up to 30 days
Title
Time of maximum observed serum concentration (Tmax) of C-terminal intact BMS-986036
Time Frame
Up to 30 days
Title
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
Time Frame
Up to 30 days
Title
Area under the serum concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of C-terminal intact BMS-986036
Time Frame
Up to 30 days
Title
Terminal elimination half-life (T-half) of C-terminal intact BMS-986036
Time Frame
Up to 30 days
Title
Apparent total body clearance (CLT/F) of C-terminal intact BMS-986036
Time Frame
Up to 30 days
Title
Apparent volume of distribution (Vz/F) of C-terminal intact BMS-986036
Time Frame
Up to 30 days
Title
Total renal clearance (CLR) of C-terminal intact BMS-986036
Time Frame
Up to 30 days
Title
Amount per fraction excreted into urine (Fe) of C-terminal intact BMS-986036
Time Frame
Up to 30 days
Title
Total amount excreted into urine (Ae) of C-terminal intact BMS-986036
Time Frame
Up to 30 days
Secondary Outcome Measure Information:
Title
Maximum observed serum concentration (Cmax) of total BMS-986036
Time Frame
Up to 30 days
Title
Time of maximum observed serum concentration (Tmax) of total BMS-986036
Time Frame
Up to 30 days
Title
Area under the serum concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] of total BMS-986036
Time Frame
Up to 30 days
Title
Area under the serum concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of total BMS-986036
Time Frame
Up to 30 days
Title
Terminal elimination half-life (T-half) of total BMS-986036
Time Frame
Up to 30 days
Title
Apparent total body clearance (CLT/F) of total BMS-986036
Time Frame
Up to 30 days
Title
Apparent volume of distribution (Vz/F) of total BMS-986036
Time Frame
Up to 30 days
Title
Total renal clearance (CLR) of total BMS-986036
Time Frame
Up to 30 days
Title
Amount per fraction excreted into urine (Fe) of total BMS-986036
Time Frame
Up to 30 days
Title
Total amount excreted into urine (Ae) of total BMS-986036
Time Frame
Up to 30 days
Title
Incidence of injection site reactions (prospective)
Time Frame
Up to 30 days
Title
Incidence of adverse events (AE)
Time Frame
Up to 30 days
Title
Incidence of serious adverse events (SAE)
Time Frame
Up to 30 days
Title
Incidence of clinically significant changes to events of special interest
Description
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
Time Frame
Up to 30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Pharmaceutical Research Associates CZ, s.r.o
City
Praha 7
ZIP/Postal Code
170 00
Country
Czechia
Facility Name
PRA Magyarorszag Kft
City
Budapest
ZIP/Postal Code
1077
Country
Hungary
Facility Name
Semmelweis Egyetem
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
Facility Name
Clinical Research Unit Hungary
City
Miskolc
ZIP/Postal Code
3529
Country
Hungary

12. IPD Sharing Statement

Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
https://www.bmsstudyconnect.com/s/US/English/USenHome
Description
BMS Clinical Trial Patient Recruiting
URL
https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls

Learn more about this trial

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

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