Clinical trial NCT02982707: Single-dose Pharmacokinetics of BMS-986177 in Participants With Hepatic Impairment Compared to Healthy Participants
Official title: Single-dose Pharmacokinetics of BMS-986177 in Participants With Hepatic Impairment Compared to Healthy Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Thrombosis
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2016-12-05
Enrollment: 26
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: A single oral dose of BMS-986177 administered to subjects of mild hepatic impairment, moderate hepatic impairment and healthy matched subjects to evaluate pharmacokinetics, safety, and tolerability in these subjects


Eligibility criteria: Inclusion Criteria:

* Women not of childbearing potential (WNOCBP) and males. Women must have documented proof they are not of childbearing potential
* BMI of 20.0 to 38.0 kg/m2, inclusive
* Hepatic subjects classified as Child-Pugh mild (Class A) or Child-Pugh moderate (Class B) who have had no significant change to disease status in past 6 months and are on stable treatment regimen
* Healthy subjects must not have clinically significant deviations from normal in medical history, physical exam, ECGs, vital signs or clinical lab values

Exclusion Criteria:

* Evidence of coagulopathy, prolonged or unexplained clinically significant bleeding, or frequent unexplained bruising or thrombus formation
* Use of corticosteroids, nonsteroidal anti-inflammatory compounds, aspirin or other antiplatelet agents or anticoagulants within 2 weeks of dosing
* Healthy subjects must not have used tobacco or have a history of drug or alcohol abuse within the last 6 months
* Subjects must not have a current or recent (within 3 months) GI disease that increases participant risk of GI bleeding or interferes with absorption of the study drug

Other protocol defined inclusion and exclusion criteria may apply

Primary outcomes:
measure: Maximum observed plasma concentration (Cmax) of BMS-986177
timeFrame: Up to 5 days
measure: Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) of BMS-987177
timeFrame: Up to 5 days
measure: Area under the plasma concentration-time curve from time zero to the time the last quantifiable concentration (AUC(0-T)) of BMS-986177
timeFrame: Up to 5 days
measure: Area under the plasma concentration-time curve from time zero to (AUC(0-72)) of BMS-986177
timeFrame: Up to 5 days
Secondary outcomes:
measure: Incidence of adverse events (AEs), serious adverse events (SAEs), and AEs leading to discontinuation
timeFrame: Screening until 30 days after discontinuation of dosing or subject's participation
measure: Number of participants with clinical laboratory abnormalities
timeFrame: Screening until 30 days after discontinuation of dosing or subject's participation
measure: Number of participants with clinically significant changes in electrical activity of the heart measured by electrocardiogram (ECG)
timeFrame: Screening until 30 days after discontinuation of dosing or subject's participation
measure: Number of participants with vital sign abnormalities
timeFrame: Screening until 30 days after discontinuation of dosing or subject's participation
Other outcomes:
Locations:
city: Miami
country: United States
facility: Clinical Pharmacology of Miami
state: Florida
city: Orlando
country: United States
facility: Orlando Clinical Research Center
state: Florida
city: San Antonio
country: United States
facility: Texas Liver Institute
state: Texas
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: Perera V, Abelian G, Li D, Wang Z, Zhang L, Lubin S, Chen W, Bello A, Murthy B. Single-Dose Pharmacokinetics of Milvexian in Participants with Mild or Moderate Hepatic Impairment Compared with Healthy Participants. Clin Pharmacokinet. 2022 Jun;61(6):857-867. doi: 10.1007/s40262-022-01110-9. Epub 2022 Mar 9.