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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02364635
• Other study ID #: CTN401614104
• Status: Completed
• Phase: Phase 1
• First received: January 22, 2015
• Last updated: September 28, 2015
• Start date: February 2015
• Est. completion date: August 2015

Study information

• Verified date: September 2015
• Source: Pronova BioPharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• icosabutate
Single dose at each dose levet

Locations

Country	Name	City	State
United Kingdom	Covance Clinical Research Unit (CRU) Ltd.	Leeds

Sponsors (1)

Lead Sponsor	Collaborator
Pronova BioPharma

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetic assessments of icosabutate - AUC	Exposure level of icosabutate measured as Area Under the Curve (AUC)	0-36 hour	No
Primary	Pharmacokinetic assessments of icosabutate - Cmax	Maximum observed plasma concentration of icosabutate (Cmax)	0-36 hour	No
Primary	Number of patients with Adverse Events	Clinically significant abnormalities found during the course of the study will be followed up until they return to normal or can be clinically explained	During the 36 hour assessment, and at post-study visit day 5-7	No