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

Pronova

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: icosabutate

Study type: Interventional

Funder types: Industry

Identifiers

NCT02364635

CTN401614104

Details and patient eligibility

About

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

Enrollment: 32 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

32 participants in 5 patient groups, including a placebo group

Icosabutate dose 1

Experimental group

Description:

Dose 1

Treatment:

Drug: icosabutate

Icosabutate dose 2

Experimental group

Description:

Dose 2

Treatment:

Drug: icosabutate

Icosabutate dose 3

Experimental group

Description:

Dose 3

Treatment:

Drug: icosabutate

Placebo

Placebo Comparator group

Description:

Placebo (medium chain triglycerides)

Treatment:

Drug: icosabutate

Icosabutate dose 4

Experimental group

Description:

Dose 4

Treatment:

Drug: icosabutate