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

NCT02364635 | Completed Phase 1

• 1 other identifier: CTN401614104
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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

Conditions

Healthy

Keywords

Phase I pharmacokinetics and safety study

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (5)

Icosabutate dose 1

EXPERIMENTAL

Dose 1

Drug: icosabutate

Icosabutate dose 2

EXPERIMENTAL

Dose 2

Drug: icosabutate

Icosabutate dose 3

EXPERIMENTAL

Dose 3

Drug: icosabutate

Placebo

PLACEBO COMPARATOR

Placebo (medium chain triglycerides)

Drug: icosabutate

Icosabutate dose 4

EXPERIMENTAL

Dose 4

Drug: icosabutate

Interventions

icosabutate DRUG

Single dose at each dose levet

Also known as: PRC-4016

Icosabutate dose 1; Icosabutate dose 2; Icosabutate dose 3; Icosabutate dose 4; Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• males of females
• any ethnic origin
• Age 18-55 years
• BMI 18.0 - 33.0 kg/m2
• generally in good health
• signed informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Pronova BioPharma: lead

Study Sites (1)

Covance Clinical Research Unit (CRU) Ltd.

Leeds, LS2 9LH, United Kingdom

Location

MeSH Terms

Interventions

icosabutate

Study Officials

• Ashley Brooks, MD

  Covance

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2015
• First Posted: February 18, 2015
• Study Start: February 1, 2015
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: September 29, 2015

Record last verified: 2015-09

Locations

GB (1)