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Trial record 4 of 7 for:    BMS-986231

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

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ClinicalTrials.gov Identifier: NCT03515980
Recruitment Status : Recruiting
First Posted : May 4, 2018
Last Update Posted : August 29, 2018
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

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

Condition or disease Intervention/treatment Phase
Liver Dysfunction Liver Insufficiency Hepatic Failure Myocardial Failure Cardiac Failure Congestive Heart Failure Heart Decompensation Drug: BMS-986231 Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : May 25, 2018
Estimated Primary Completion Date : December 25, 2018
Estimated Study Completion Date : December 26, 2018

Arm Intervention/treatment
Experimental: Mild hepatic impairment
Based on Hepatic Function Impairment - Child-Pugh A score 5 to 6 points
Drug: BMS-986231
Intravenous (IV) administration

Experimental: Moderate hepatic impairment
Based on Hepatic Function Impairment - Child-Pugh B score 7 to 9 points
Drug: BMS-986231
Intravenous (IV) administration

Experimental: Severe hepatic impairment
Based on Hepatic Function Impairment - Child-Pugh C score 10 to 15 points
Drug: BMS-986231
Intravenous (IV) administration

Experimental: Normal hepatic function
Based on Hepatic Function Impairment as defined by the investigator
Drug: BMS-986231
Intravenous (IV) administration




Primary Outcome Measures :
  1. Area under the concentration-time curve from time 0 extrapolated to infinity [AUC(INF)] derived from plasma concentration [ Time Frame: Up to 2 days ]
  2. 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 ]
  3. Maximum plasma concentration (Cmax) [ Time Frame: Up to 2 days ]

Secondary Outcome Measures :
  1. Incidence of adverse events (AE) [ Time Frame: Up to 33 days ]
  2. Incidence of serious adverse events (SAE) [ Time Frame: Up to 33 days ]
  3. Incidence of Laboratory Test Result Abnormalities [ Time Frame: Up to 11 days ]
  4. Clearance (CL) derived from plasma concentration [ Time Frame: Up to 2 days ]
  5. Terminal elimination half-life (t1/2) derived from plasma concentration [ Time Frame: Up to 2 days ]
  6. Time of maximum observed plasma concentration (Tmax) [ Time Frame: Up to 2 days ]
  7. Terminal elimination phase rate constant (λz) derived from plasma concentration [ Time Frame: Up to 2 days ]
  8. Volume of distribution during terminal phase (Vz) derived from plasma concentration [ Time Frame: Up to 2 days ]
  9. 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 ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03515980


Contacts
Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT # and Site #.

Locations
Hungary
Local Institution Recruiting
Budapest, Hungary, 1083
Contact: Site 0002         
Local Institution Recruiting
Miskolc, Hungary, 3529
Contact: Site 0003         
Poland
Local Institution Recruiting
Lublin, Poland, 20-954
Contact: Site 0004         
Local Institution Recruiting
Otwock, Poland, 05-400
Contact: Site 0001         
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03515980     History of Changes
Other Study ID Numbers: CV013-026
2017-004914-24 ( EudraCT Number )
First Posted: May 4, 2018    Key Record Dates
Last Update Posted: August 29, 2018
Last Verified: August 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
Heart Failure
Liver Diseases
Liver Failure
Hepatic Insufficiency
Heart Diseases
Cardiovascular Diseases
Digestive System Diseases