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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03515980
Other study ID # CV013-026
Secondary ID 2017-004914-24
Status Completed
Phase Phase 1
First received
Last updated
Start date May 25, 2018
Est. completion date August 29, 2019

Study information

Verified date August 2020
Source Bristol-Myers Squibb
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

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

Study Design


Intervention

Drug:
BMS-986231
Intravenous (IV) administration

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

Hungary,  Poland, 

Outcome

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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