A Study to Evaluate the Pharmacokinetics of BMS-986141 in Participants With Hepatic Impairment Compared to Healthy Participants

NCT02985632 — Phase 1, Withdrawn, Bristol-Myers Squibb

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Single-dose Pharmacokinetics of BMS-986141 in Participants With Hepatic Impairment Compared to Healthy Participants

Registry	NCT02985632
Status	Withdrawn - Business objectives have changed.
Phase	Phase 1
Study type	Interventional; non randomized, parallel, masking: none, treatment
Sponsor	Bristol-Myers Squibb (Industry)
Conditions	Hepatic Impairment
Interventions	BMS-986141 (Drug)
Dates	start 2017-01-11 (estimated), primary completion 2017-05-18 (estimated), completion 2017-07-07 (estimated), first posted 2016-12-07, last updated 2017-02-06
Locations	3 sites in United States

-Summary

An oral dose of BMS-986141 administered in Hepatic Impairment and Healthy Participants to evaluate pharmacokinetics in this patient population.

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+Arms and interventions

Arm	Type	Interventions	Description
Mild Hepatic Impairment Subjects	Experimental	Drug: BMS-986141	Subjects given an oral dose of BMS-986141.
Moderate Hepatic Impairment Subjects	Experimental	Drug: BMS-986141	Subjects given an oral dose of BMS-986141.
Healthy Subjects	Experimental	Drug: BMS-986141	Subjects given an oral dose of BMS-986141.

BMS-986141 (Drug)

+Outcome measures

Primary outcomes

Maximum observed plasma concentration (Cmax) of BMS-986141 [Days 1-7 (healthy) Days 1-10 (heaptic Impairment)]
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) of BMS-986141 [Days 1-7 (healthy) Days 1-10 (heaptic Impairment)]
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) of BMS-986141 [Days 1-7 (healthy) Days 1-10 (heaptic Impairment)]
Area under the plasma concentration-time curve from time zero to 144 hours postdose (AUC(0-144h)) of BMS-986141 [Days 1-7 (healthy) Days 1-10 (heaptic Impairment)]

Secondary outcomes

Safety endpoints include the incidence of adverse events (AEs), serious adverse events (SAEs), leading to discontinuation. [Days 1-7 (healthy) Days 1-10 (heaptic Impairment)]

+Eligibility

Sex: All, ages: 18 Years to 70 Years, accepts healthy volunteers

Inclusion Criteria:

* Women not of childbearing potential (WNOCBP), and males, ages 18 to 70 years, inclusive.
* BMI of 20.0 to 38.0 kg/m2 inclusive
* Participants who a history of normal renal function
* Subjects with hepatic impairment must be on a stable dose of medication and/or treatment regimen
* Healthy subjects to the extent possible matched to four subjects with hepatic impairment with regard to body weight, age and gender, as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations

Exclusion Criteria:

* Any nonhepatic significant acute or chronic medical illness that could affect participant safety or data interpretation as determined by the investigator.
* History of recurrent dizziness or fall risk within 4 weeks of study drug administration
* History of primarily cholestatic liver diseases, autoimmune liver disease, metastatic liver disease or active alcoholic hepatitis
* History of known bleeding diathesis or coagulation disorder (eg, thrombotic thrombocytopenic purpura)
* Other protocol defined exclusion criteria could apply

+Locations (3)

Facility	City	Country
Clinical Pharmacology of Miami	Miami, Florida	United States
Clinical Research Center	Orlando, Florida	United States
Texas Liver Institute	San Antonio, Texas	United States

+Investigators

Bristol-Myers Squibb, Study director, Bristol-Myers Squibb