Congestive Heart Failure Clinical Trial
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
Verified date | August 2020 |
Source | Bristol-Myers Squibb |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is an investigational study of experimental Medication BMS-986231 given to participants with weakened or damaged liver function.
Status | Completed |
Enrollment | 76 |
Est. completion date | August 29, 2019 |
Est. primary completion date | August 29, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Hungary | Semmelweis Egyetem Altalanos Orvostudomanyi Kar | Budapest | |
Hungary | Clinical Research Unit Hungary | Miskolc | |
Poland | BioVirtus Centrum Medyczne | Jozefow | |
Poland | KO-MED Centra Kliniczne Lublin | Lublin |
Lead Sponsor | Collaborator |
---|---|
Bristol-Myers Squibb |
Hungary, Poland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Area under the concentration-time curve from time 0 extrapolated to infinity [AUC(INF)] derived from plasma concentration | Up to 2 days | ||
Primary | 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 | Up to 2 days | ||
Primary | Maximum plasma concentration (Cmax) | Up to 2 days | ||
Secondary | Incidence of adverse events (AE) | Up to 33 days | ||
Secondary | Incidence of serious adverse events (SAE) | Up to 33 days | ||
Secondary | Incidence of Laboratory Test Result Abnormalities | Up to 11 days | ||
Secondary | Clearance (CL) derived from plasma concentration | Up to 2 days | ||
Secondary | Terminal elimination half-life (t1/2) derived from plasma concentration | Up to 2 days | ||
Secondary | Time of maximum observed plasma concentration (Tmax) | Up to 2 days | ||
Secondary | Terminal elimination phase rate constant (?z) derived from plasma concentration | Up to 2 days | ||
Secondary | Volume of distribution during terminal phase (Vz) derived from plasma concentration | Up to 2 days | ||
Secondary | Metabolite ratio determined using AUC(INF) for metabolite/AUC(INF) for BMS-986231 [MRAUC(INF)] derived from plasma concentration | Up to 2 days |
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