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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Pronova BioPharma · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
DRUG	icosabutate	Single dose at each dose levet

Timeline

• Start date: 2015-02-01
• Primary completion: 2015-08-01
• Completion: 2015-08-01
• First posted: 2015-02-18
• Last updated: 2015-09-29

Locations

1 site across 1 country: United Kingdom