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

• Status: Completed
• Trial end date: 2014-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Pronova BioPharma
• Treatments: Flurbiprofen; Midazolam; Omeprazole; Simvastatin

Criteria

Inclusion Criteria:

• males or females

• any ethnic origin

• age 18-60 years

• BMI 8.0 - 35.0 kg/m2

• generally good health

• signed informed consent

Exclusion Criteria:

• males or females not willing to use appropriate contraception

• recent blood donation

• recent blood received

• high consumption of alcohol

• high consumption og tobacco

• subjects who have engaged in heavy exercise last two weeks

• prescribed systemic or topical medication taken recently, or supplements/remedies interfering with study procedures or safety

• other medication known to alter drug absorption or elimination

• abnormal hearth rate or blood pressure

• significant history of drug allergy or hypersensitivity to treatment ingredients

• other significant medical history or physical findings

• pregnant or lactating

• Poor metabolizers for CYP2C9 or CYP2C19

• subjects previously taken part in or withdrawn from study or subjects that according to investigator should not participate