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

Information source: Pronova BioPharma
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: PRC-4016 (icosabutate) (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Pronova BioPharma

Official(s) and/or principal investigator(s):
Joseph Chiesa, MD, Principal Investigator, Affiliation: Covance Clinical Research Unit Ltd.

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.

Clinical Details

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

Study design: Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Primary outcome:

Area under curve for effect of PRC-4016 at steady state on the PK of CYP3A substrates (midazolam, simvastatin), a CYP2C9 substrate (omeprazole) and a CYP2C19 substrate (flurbiprofen) in healthy male/female subjects.

Peak plasma concentration for effect of PRC-4016 at steady state on the PK of CYP3A substrates (midazolam, simvastatin), a CYP2C9 substrate (omeprazole) and a CYP2C19 substrate (flurbiprofen) in healthy male/female subjects.

Secondary outcome: Number of participants with adverse events as a measure of safety and tolerability of PRC-4016 co-administered with midazolam, omeprazole, flurbiprofen and simvastatin 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.

Eligibility

Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.

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

Locations and Contacts

Covance Clinical research Unit (CRU) Ltd,Springfield House, Hyde street, Leeds LS2 9LH, United Kingdom
Additional Information

Starting date: August 2014
Last updated: February 13, 2015

Page last updated: August 23, 2015

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