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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2014-10-31

Brief Summary

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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.

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Detailed Description

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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

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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PRC-4016 (Icosabutate)

Group Type EXPERIMENTAL

PRC-4016 (icosabutate)

Intervention Type DRUG

Midazolam, omeprazole, flurbiprofen and simvastatin interaction with PRC-4016. Detailed description under "Study description"

Interventions

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PRC-4016 (icosabutate)

Midazolam, omeprazole, flurbiprofen and simvastatin interaction with PRC-4016. Detailed description under "Study description"

Intervention Type DRUG

Other Intervention Names

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Midazolam, omeprazole, flurbiprofen and simvastatin

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes