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

Study Overview
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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.

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.

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Drug: PRC-4016 (icosabutate)


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PRC-4016 (Icosabutate)<br> | Drug: PRC-4016 (icosabutate)<br>* Midazolam, omeprazole, flurbiprofen and simvastatin interaction with PRC-4016. Detailed description under Study description<br>* Other names: Midazolam, omeprazole, flurbiprofen and simvastatin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Blood-sampling | 24 h postdose | 
| 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. | Blood-sampling | 24 hours post-dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Adverse event recording | 24 h postdose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Phase I drug-drug interaction