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

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02364635

Enrollment

Registered

2015-02-18

Start date

2015-02-28

Completion date

2015-08-31

Last updated

2015-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Phase I pharmacokinetics and safety study

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

Interventions

DRUGicosabutate

Single dose at each dose levet

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Pharmacokinetic assessments of icosabutate - AUC	0-36 hour	Exposure level of icosabutate measured as Area Under the Curve (AUC)
Pharmacokinetic assessments of icosabutate - Cmax	0-36 hour	Maximum observed plasma concentration of icosabutate (Cmax)
Number of patients with Adverse Events	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

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026