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Completed

NCT Number: NCT03332186

A Study of Experimental Medication BMS-986231 in Patients With Different Levels of Kidney Function

The purpose of this study is to investigate experimental medication BMS-986231 in patients with different levels of kidney function.

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Key information

Conditions

Myocardial Failure Cardiac Failure Cardiovascular Diseases Congestive Heart Failure Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Heart Diseases Heart Failure Kidney Diseases Kidney Failure Male Urogenital Diseases Renal Failure Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Local Institution, Prague, Czechia

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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
  • BMI ≥ 18 kg/m^2 and ≤ 35 kg/m^2
  • Heart rate ≥ 50 bpm and < 95 bpm
  • Stable renal impairment, defined as no clinically significant change in disease status, as documented by the subject's most recent eGFR assessment
  • No changes in medication within 30 days prior to study drug administration

Exclusion criteria

  • Clinically relevant abnormal medical history, abnormal findings on physical examination, vital signs, ECG, or laboratory tests
  • History of chronic headaches, defined as occurring 15 days or more a month, over the previous 3 months
  • History of headaches related to caffeine withdrawal
  • History of migraine or cluster headaches
  • Patients requiring dialysis will not be enrolled in this study

Other protocol defined inclusion/exclusion criteria could apply

Treatment and study plan

BMS-986231

Drug

Intravenous infusion administration

Primary outcomes

  1. Maximum observed plasma concentration (Cmax) derived from plasma concentration

    Time frame: 11 days

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

    Time frame: 11 days

  3. Metabolite ratio determined using AUC0-inf for metabolite/AUC0-inf [MRAUC(0-inf)] derived from plasma concentration

    Time frame: 11 days

  4. Clearance (CL) derived from plasma concentration

    Time frame: 11 days

  5. Renal clearance (CLR) derived from urine concentration

    Time frame: 11 days

Secondary outcomes

  1. Number of adverse events (AE)

    Time frame: Up to 31 days

  2. Number of serious adverse events (SAE)

    Time frame: Up to 31 days

  3. Terminal elimination half-life (t1/2)

    Time frame: Up to 36 hours

  4. Time of maximum observed plasma concentration (Tmax)

    Time frame: Up to 36 hours

  5. AUC up to time t, where t is the last time point with concentrations above the lower limit of quantitation (AUCt)

    Time frame: Up to 36 hours

  6. Terminal elimination phase rate constant (λz)

    Time frame: Up to 36 hours

  7. Volume of distribution during terminal phase (Vz)

    Time frame: Up to 36 hours

  8. Fraction of administered drug excreted into urine (Fe)

    Time frame: Up to 36 hours

  9. Cumulative amount excreted from time 0 to the time of the last quantifiable sample (Aelast)

    Time frame: Up to 36 hours

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 Subjects With Varying Degrees of Renal Function

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Nov 6, 2017
Registry last updated
Sep 11, 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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