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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: icosabutate

• Registration Number: NCT02364635
• Lead Sponsor: Pronova BioPharma

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-01-22
• Study Start: 2015-02
• Study First Submitted QC: 2015-02-10
• Study First Posted: 2015-02-18
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-28
• Last Update Posted: 2015-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Icosabutate dose 4	icosabutate	Dose 4
Icosabutate dose 1	icosabutate	Dose 1
Icosabutate dose 3	icosabutate	Dose 3
Placebo	icosabutate	Placebo (medium chain triglycerides)
Icosabutate dose 2	icosabutate	Dose 2

Primary Outcome Measures

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

Trial Locations

Locations (1)

Covance Clinical Research Unit (CRU) Ltd.; 🇬🇧 Leeds, United Kingdom