This a phase 1, open label, single dose, parallel cohort study to determine the pharmacokinetics (PK) of study drug (ESK-001) in healthy volunteer participants, and participants with mild, moderate, and severe hepatic impairment.
This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.)
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
48
Single oral dose of ESK-001 in participants from all cohorts
Orange County Research Center
Lake Forest, California, United States
RECRUITINGPanax Clinical Research
Miami Lakes, Florida, United States
RECRUITINGOrlando Clinical Research Center
Orlando, Florida, United States
RECRUITINGMaximum observed plasma concentration (Cmax)
Time frame: 48 hours
Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration [AUC(0-T)]
Time frame: 48 hours
Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)]
Time frame: 48 hours
Incidence of nonserious adverse events (AE), serious adverse events (SAE), and AE leading to discontinuation
Time frame: 48 hours
Number of clinically significant changes in clinical laboratory values, vital signs, ECGs, and physical examinations
Time frame: 48 hours
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Alliance for Multispecialty Research
Knoxville, Tennessee, United States
RECRUITING