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

NCT02364635 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2015-09-29

No results posted yet for this study

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

Interventions

DRUG

icosabutate

Single dose at each dose levet

Sponsors & Collaborators

  • Pronova BioPharma

    lead INDUSTRY

Principal Investigators

  • Ashley Brooks, MD · Covance

Study Design

Allocation
RANDOMIZED
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-02-28
Primary Completion
2015-08-31
Completion
2015-08-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02364635 on ClinicalTrials.gov