drugset / Trial / NCT02367937

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

NCT02367937

Phase 1 Completed 16 enrolled Pronova BioPharma
NaSingle-groupOpen-label

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.

Timeline

Start
2014-08
Primary completion
2014-10
Completion
2014-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Icosabutate Small molecule 600 mg

Indications

No indication recorded.