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Completed

NCT Number: NCT03674476

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

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

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Key information

Conditions

NAFLD Digestive System Diseases Fatty Liver Liver Diseases Non-alcoholic Fatty Liver Disease Nonalcoholic Fatty Liver Disease Nonalcoholic Steatohepatitis

Age range

21 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pharmaceutical Research Associates CZ, s.r.o, Prague, Czechia

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BMS-986036

Drug

Specified dose on specified days

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Sep 17, 2018
Registry last updated
Oct 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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