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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03515980
• Date of registration: 24/04/2018
• Prospective Registration: Yes
• Primary sponsor: Bristol-Myers Squibb
• Public title: An Investigational Study of Experimental Medication BMS-986231 Given in Participants With Different Levels of Liver Function
• Scientific 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
• Date of first enrolment: May 25, 2018
• Target sample size: 76
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03515980
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

Hungary, Poland

Contacts

• Name: Bristol-Myers Squibb
• Affiliation: Bristol-Myers Squibb

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Liver Insufficiency

Myocardial Failure

Congestive Heart Failure

Cardiac Failure

Heart Decompensation

Hepatic Failure

Liver Dysfunction

Intervention(s)

Drug: BMS-986231

Primary Outcome(s)

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]

Area under the concentration-time curve from time 0 extrapolated to infinity [AUC(INF)] derived from plasma concentration [Time Frame: Up to 2 days]

Maximum plasma concentration (Cmax) [Time Frame: Up to 2 days]

Secondary Outcome(s)

Incidence of serious adverse events (SAE) [Time Frame: Up to 33 days]

Terminal elimination phase rate constant (?z) derived from plasma concentration [Time Frame: Up to 2 days]

Time of maximum observed plasma concentration (Tmax) [Time Frame: Up to 2 days]

Terminal elimination half-life (t1/2) derived from plasma concentration [Time Frame: Up to 2 days]

Volume of distribution during terminal phase (Vz) derived from plasma concentration [Time Frame: Up to 2 days]

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]

Clearance (CL) derived from plasma concentration [Time Frame: Up to 2 days]

Incidence of adverse events (AE) [Time Frame: Up to 33 days]

Incidence of Laboratory Test Result Abnormalities [Time Frame: Up to 11 days]

Secondary ID(s)

2017-004914-24

CV013-026

Source(s) of Monetary Support

Please refer to primary and secondary sponsors