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Completed

NCT Number: NCT02364635

Icosabutate - A Phase I, 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

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Covance Clinical Research Unit (CRU) Ltd.

Leeds, LS2 9LH, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Icosabutate

Drug

Single dose at each dose levet

Other names: PRC-4016

Primary outcomes

  1. Pharmacokinetic assessments of icosabutate - AUC

    Time frame: 0-36 hour

    Exposure level of icosabutate measured as Area Under the Curve (AUC)

  2. Pharmacokinetic assessments of icosabutate - Cmax

    Time frame: 0-36 hour

    Maximum observed plasma concentration of icosabutate (Cmax)

  3. 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

Sponsors and collaborators

Lead sponsor

Pronova BioPharma

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Feb 18, 2015
Registry last updated
Sep 29, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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