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Completed

NCT Number: NCT03515980

An Investigational Study of Experimental Medication BMS-986231 Given in Participants With Different Levels of Liver Function

This is an investigational study of experimental Medication BMS-986231 given to participants with weakened or damaged liver function.

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Key information

Conditions

Liver Dysfunction Cardiac Failure Cardiovascular Diseases Congestive Heart Failure Digestive System Diseases Heart Decompensation Heart Diseases Heart Failure Hepatic Failure Hepatic Insufficiency Liver Diseases Liver Failure Liver Insufficiency Myocardial Failure

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Semmelweis Egyetem Altalanos Orvostudomanyi Kar, Budapest, Hungary

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

  • Body weight ≥ 45 kg and ≤ 120 kg and BMI ≥ 18 kg/m2 and ≤ 35 kg/m2
  • Heart rate ≥ 50 bpm and < 95 bpm
  • Women of childbearing potential must have a negative urine or serum pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 24 hours prior to the start of study treatment

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 volunteer
  • History of chronic headaches (defined as occurring 15 days or more a month, over the previous 3 months), headaches related to caffeine withdrawal (ie, coffee, soda, tea, energy drinks, etc.), or moderately severe to severe headaches
  • History of migraine or cluster headaches

Other protocol defined inclusion/exclusion criteria could apply

Treatment and study plan

BMS-986231

Drug

Intravenous (IV) administration

Primary outcomes

  1. Area under the concentration-time curve from time 0 extrapolated to infinity [AUC(INF)] derived from plasma concentration

    Time frame: Up to 2 days

  2. AUC from time 0 up to time T, where T is the last time point with concentrations above the lower limit of quantitation [AUC(0-T)] derived from plasma concentration

    Time frame: Up to 2 days

  3. Maximum plasma concentration (Cmax)

    Time frame: Up to 2 days

Secondary outcomes

  1. Incidence of adverse events (AE)

    Time frame: Up to 33 days

  2. Incidence of serious adverse events (SAE)

    Time frame: Up to 33 days

  3. Incidence of Laboratory Test Result Abnormalities

    Time frame: Up to 11 days

  4. Clearance (CL) derived from plasma concentration

    Time frame: Up to 2 days

  5. Terminal elimination half-life (t1/2) derived from plasma concentration

    Time frame: Up to 2 days

  6. Time of maximum observed plasma concentration (Tmax)

    Time frame: Up to 2 days

  7. Terminal elimination phase rate constant (λz) derived from plasma concentration

    Time frame: Up to 2 days

  8. Volume of distribution during terminal phase (Vz) derived from plasma concentration

    Time frame: Up to 2 days

  9. Metabolite ratio determined using AUC(INF) for metabolite/AUC(INF) for BMS-986231 [MRAUC(INF)] derived from plasma concentration

    Time frame: Up to 2 days

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-986231 in Participants With Varying Degrees of Hepatic Impairment

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
May 4, 2018
Registry last updated
Aug 27, 2020

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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