PRC 4016 (Icosabutate) - A Phase I, Single-Blind, Placebo Controlled, Single Oral Dose, Safety, Tolerability and Pharmacokinetic Study in Healthy Subjects
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
A Phase I, Open-Label Study to Assess the Effects of PRC-4016 (Icosabutate) on the Pharmacokinetics of Midazolam, Omeprazole, Flurbiprofen and Simvastatin in Healthy Male/Female Subjects
The aim of the study is to evaluate the effect of PRC-4016 at steady state on the pharmacokinetics (PK) of cytochrome P450 (CYP) 3A substrates (midazolam, simvastatin), a CYP2C9 substrate (omeprazole) and a CYP2C19 substrate (flurbiprofen) in healthy male/female subjects.