NCT02367937

PRC-4016 (Icosabutate) Phase I Drug-drug Interaction Study

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Pronova BioPharma · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	PRC-4016 (icosabutate)	Midazolam, omeprazole, flurbiprofen and simvastatin interaction with PRC-4016. Detailed description under "Study description"

Timeline

• Start date: 2014-08-01
• Primary completion: 2014-10-01
• Completion: 2014-10-01
• First posted: 2015-02-20
• Last updated: 2015-02-20

Locations

1 site across 1 country: United Kingdom