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

Launched by PRONOVA BIOPHARMA · Feb 13, 2015

Keywords

ClinConnect Summary

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...

Gender

ALL

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• • subjects previously taken part in or withdrawn from study or subjects that according to investigator should not participate