Icosabutate - A Phase I, Single Oral Dose, Safety, Tolerability and Pharmacokinetic Study in Healthy Subjects

Study Overview
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Brief Summary
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PRC 4016 (Icosabutate) - A Phase I, Single-Blind, Placebo Controlled, Single Oral Dose, Safety, Tolerability and Pharmacokinetic Study in Healthy Subjects Objective: To assess the safety and tolerability of single ascending oral doses of icosabutate in healthy subjects To evaluate the pharmacokinetic (PK) parameters of icosabutate in healthy subjects

Official Title
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PRC 4016 (Icosabutate) - A Phase I, Single-Blind, Placebo Controlled, Single Oral Dose, Safety, Tolerability and Pharmacokinetic Study in Healthy Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: icosabutate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: males of females any ethnic origin Age 18-55 years BMI 18.0 - 33.0 kg/m2 generally in 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 of 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 know to alter drug absorption or elimination abnormal heart rate or blood pressure or 12-lead ECG significant history of drug allergy, or hypersensitivity to treatment ingredients ocular disorder requiring topical ocular therapy, or recent allergic eye disease other significant medical history or physical findings

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 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

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Icosabutate dose 1<br>Dose 1 | Drug: icosabutate<br>* Single dose at each dose levet<br>* Other names: PRC-4016;|
| Experimental: Icosabutate dose 2<br>Dose 2 | Drug: icosabutate<br>* Single dose at each dose levet<br>* Other names: PRC-4016;|
| Experimental: Icosabutate dose 3<br>Dose 3 | Drug: icosabutate<br>* Single dose at each dose levet<br>* Other names: PRC-4016;|
| Placebo Comparator: Placebo<br>Placebo (medium chain triglycerides) | Drug: icosabutate<br>* Single dose at each dose levet<br>* Other names: PRC-4016;|
| Experimental: Icosabutate dose 4<br>Dose 4 | Drug: icosabutate<br>* Single dose at each dose levet<br>* Other names: PRC-4016;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic assessments of icosabutate - AUC | Exposure level of icosabutate measured as Area Under the Curve (AUC) | 0-36 hour | 
| Pharmacokinetic assessments of icosabutate - Cmax | Maximum observed plasma concentration of icosabutate (Cmax) | 0-36 hour | 
| Number of patients with Adverse Events | Clinically significant abnormalities found during the course of the study will be followed up until they return to normal or can be clinically explained | During the 36 hour assessment, and at post-study visit day 5-7 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Phase I pharmacokinetics and safety study