PRC 4016 (Icosabutate) - A Phase I, Single-Blind, Placebo Controlled, Single Oral Dose, Safety, Tolerability and Pharmacokinetic Study in Healthy Subjects Objective: * To assess the safety and tolerability of single ascending oral doses of icosabutate in healthy subjects * To evaluate the pharmacokinetic (PK) parameters of icosabutate in healthy subjects
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
DOUBLE
Enrollment
32
Single dose at each dose levet
Covance Clinical Research Unit (CRU) Ltd.
Leeds, United Kingdom
Pharmacokinetic assessments of icosabutate - AUC
Exposure level of icosabutate measured as Area Under the Curve (AUC)
Time frame: 0-36 hour
Pharmacokinetic assessments of icosabutate - Cmax
Maximum observed plasma concentration of icosabutate (Cmax)
Time frame: 0-36 hour
Number of patients with Adverse Events
Clinically significant abnormalities found during the course of the study will be followed up until they return to normal or can be clinically explained
Time frame: During the 36 hour assessment, and at post-study visit day 5-7
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