Clinical trial NCT03515980: An Investigational Study of Experimental Medication BMS-986231 Given in Participants With Different Levels of Liver Function
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Liver Dysfunction
Liver Insufficiency
Hepatic Failure
Myocardial Failure
Cardiac Failure
Congestive Heart Failure
Heart Decompensation
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2018-05-04
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Area under the concentration-time curve from time 0 extrapolated to infinity [AUC(INF)] derived from plasma concentration
timeFrame: Up to 2 days
measure: 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
timeFrame: Up to 2 days
measure: Maximum plasma concentration (Cmax)
timeFrame: Up to 2 days
Secondary outcomes:
measure: Incidence of adverse events (AE)
timeFrame: Up to 33 days
measure: Incidence of serious adverse events (SAE)
timeFrame: Up to 33 days
measure: Incidence of Laboratory Test Result Abnormalities
timeFrame: Up to 11 days
measure: Clearance (CL) derived from plasma concentration
timeFrame: Up to 2 days
measure: Terminal elimination half-life (t1/2) derived from plasma concentration
timeFrame: Up to 2 days
measure: Time of maximum observed plasma concentration (Tmax)
timeFrame: Up to 2 days
measure: Terminal elimination phase rate constant (λz) derived from plasma concentration
timeFrame: Up to 2 days
measure: Volume of distribution during terminal phase (Vz) derived from plasma concentration
timeFrame: Up to 2 days
measure: Metabolite ratio determined using AUC(INF) for metabolite/AUC(INF) for BMS-986231 [MRAUC(INF)] derived from plasma concentration
timeFrame: Up to 2 days
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: Semmelweis Egyetem Altalanos Orvostudomanyi Kar
city: Miskolc
country: Hungary
facility: Clinical Research Unit Hungary
city: Jozefow
country: Poland
facility: BioVirtus Centrum Medyczne
city: Lublin
country: Poland
facility: KO-MED Centra Kliniczne Lublin
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: