Healthy Clinical Trial
Official title:
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.
Day 1: Subject will receive single oral doses of 2.5 mg midazolam, 20 mg omeprazole and 50
mg flurbiprofen morning Day 2: Subject will receive a single oral dose of 40 mg simvastatin
on the morning of Day 2. Day 4: Subjects will commence the multiple-dose regimen for
PRC-4016 (600 mg once daily) for 11 days. Day 12: Subjects will be given single oral doses
of 2.5 mg midazolam, 20 mg omeprazole and 50 mg flurbiprofen co-administered with 600 mg
PRC-4016.
Day 13, subjects will be given a single oral dose of 40 mg simvastatin co-administered with
600 mg PRC-4016.
All subjects will return for a post-study visit 7 to 10 days after their final dose.
;
Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label
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