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

September 28, 2015 updated by: Pronova BioPharma

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Leeds, United Kingdom, LS2 9LH
        • Covance Clinical Research Unit (CRU) Ltd.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Icosabutate dose 1
Dose 1
Drug: icosabutate
Single dose at each dose levet
Other Names:
  • PRC-4016
EXPERIMENTAL: Icosabutate dose 2
Dose 2
Drug: icosabutate
Single dose at each dose levet
Other Names:
  • PRC-4016
EXPERIMENTAL: Icosabutate dose 3
Dose 3
Drug: icosabutate
Single dose at each dose levet
Other Names:
  • PRC-4016
PLACEBO_COMPARATOR: Placebo
Placebo (medium chain triglycerides)
Drug: icosabutate
Single dose at each dose levet
Other Names:
  • PRC-4016
EXPERIMENTAL: Icosabutate dose 4
Dose 4
Drug: icosabutate
Single dose at each dose levet
Other Names:
  • PRC-4016

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetic assessments of icosabutate - AUC
Time Frame: 0-36 hour
Exposure level of icosabutate measured as Area Under the Curve (AUC)
0-36 hour
Pharmacokinetic assessments of icosabutate - Cmax
Time Frame: 0-36 hour
Maximum observed plasma concentration of icosabutate (Cmax)
0-36 hour
Number of patients with Adverse Events
Time Frame: 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
During the 36 hour assessment, and at post-study visit day 5-7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pronova BioPharma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (ACTUAL)

August 1, 2015

Study Completion (ACTUAL)

August 1, 2015

Study Registration Dates

First Submitted

January 22, 2015

First Submitted That Met QC Criteria

February 10, 2015

First Posted (ESTIMATE)

February 18, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

September 29, 2015

Last Update Submitted That Met QC Criteria

September 28, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CTN401614104

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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