Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03674476
Recruitment Status : Completed
First Posted : September 17, 2018
Last Update Posted : October 8, 2019
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

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

Condition or disease Intervention/treatment Phase
NAFLD Nonalcoholic Fatty Liver Disease Nonalcoholic Steatohepatitis Drug: BMS-986036 Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : September 11, 2018
Actual Primary Completion Date : June 24, 2019
Actual Study Completion Date : June 24, 2019


Arm Intervention/treatment
Experimental: Mild Renal Impairment
The renal function will be defined by estimated glomerular filtration rate (eGFR) at Screening.
Drug: BMS-986036
Specified dose on specified days

Experimental: Moderate Renal Impairment
The renal function will be defined by estimated glomerular filtration rate (eGFR) at Screening.
Drug: BMS-986036
Specified dose on specified days

Experimental: Severe Renal Impairment
The renal function will be defined by estimated glomerular filtration rate (eGFR) at Screening.
Drug: BMS-986036
Specified dose on specified days

Normal
The renal function will be defined by estimated glomerular filtration rate (eGFR) at Screening.
Drug: BMS-986036
Specified dose on specified days




Primary Outcome Measures :
  1. Maximum observed serum concentration (Cmax) of C-terminal intact BMS-986036 [ Time Frame: Up to 30 days ]
  2. Time of maximum observed serum concentration (Tmax) of C-terminal intact BMS-986036 [ Time Frame: Up to 30 days ]
  3. 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 ]
  4. 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 ]
  5. Terminal elimination half-life (T-half) of C-terminal intact BMS-986036 [ Time Frame: Up to 30 days ]
  6. Apparent total body clearance (CLT/F) of C-terminal intact BMS-986036 [ Time Frame: Up to 30 days ]
  7. Apparent volume of distribution (Vz/F) of C-terminal intact BMS-986036 [ Time Frame: Up to 30 days ]
  8. Total renal clearance (CLR) of C-terminal intact BMS-986036 [ Time Frame: Up to 30 days ]
  9. Amount per fraction excreted into urine (Fe) of C-terminal intact BMS-986036 [ Time Frame: Up to 30 days ]
  10. Total amount excreted into urine (Ae) of C-terminal intact BMS-986036 [ Time Frame: Up to 30 days ]

Secondary Outcome Measures :
  1. Maximum observed serum concentration (Cmax) of total BMS-986036 [ Time Frame: Up to 30 days ]
  2. Time of maximum observed serum concentration (Tmax) of total BMS-986036 [ Time Frame: Up to 30 days ]
  3. 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 ]
  4. 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 ]
  5. Terminal elimination half-life (T-half) of total BMS-986036 [ Time Frame: Up to 30 days ]
  6. Apparent total body clearance (CLT/F) of total BMS-986036 [ Time Frame: Up to 30 days ]
  7. Apparent volume of distribution (Vz/F) of total BMS-986036 [ Time Frame: Up to 30 days ]
  8. Total renal clearance (CLR) of total BMS-986036 [ Time Frame: Up to 30 days ]
  9. Amount per fraction excreted into urine (Fe) of total BMS-986036 [ Time Frame: Up to 30 days ]
  10. Total amount excreted into urine (Ae) of total BMS-986036 [ Time Frame: Up to 30 days ]
  11. Incidence of injection site reactions (prospective) [ Time Frame: Up to 30 days ]
  12. Incidence of adverse events (AE) [ Time Frame: Up to 30 days ]
  13. Incidence of serious adverse events (SAE) [ Time Frame: Up to 30 days ]
  14. Incidence of clinically significant changes to events of special interest [ Time Frame: Up to 30 days ]
    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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   21 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03674476


Locations
Layout table for location information
Czechia
Pharmaceutical Research Associates CZ, s.r.o
Praha 7, Czechia, 170 00
Hungary
PRA Magyarorszag Kft
Budapest, Hungary, 1077
Semmelweis Egyetem
Budapest, Hungary, 1083
Clinical Research Unit Hungary
Miskolc, Hungary, 3529
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Layout table for investigator information
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Additional Information:
Layout table for additonal information
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03674476    
Other Study ID Numbers: MB130-065
2018-001497-19 ( EudraCT Number )
First Posted: September 17, 2018    Key Record Dates
Last Update Posted: October 8, 2019
Last Verified: October 2019

Layout table for additional information
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:
Layout table for MeSH terms
Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Digestive System Diseases