Study in Healthy Subjects to Compare the Concentrations of the Omega-3 Fatty Acids EPA and DHA in Blood When Delivered as Three New Capsules in Relation to the Epanova® Capsule Under Fasting and Fed Conditions

NCT ID: NCT02359045

Last Updated: 2017-05-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 137 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-12
• Study Completion Date: 2015-07-27

Brief Summary

This study is a randomized, open-label, cross-over study in healthy subjects performed at a single study center. The study is divided into two parts, Part 1 and Part 2. The purpose of the study is to compare the pharmacokinetics (PK) of three different prototype capsule formulations (omega-3-carboxylic acids test formulations) with Epanova® capsules 1000 mg under fasted conditions in Part 1 and under fed conditions in Part 2. The results will be used as basis for choice of formulation for further pharmaceutical development.

Detailed Description

To assess the relative bioavailability of the different omega-3-carboxylic acids prototype capsule formulations in relation to Epanova® capsules 1000 mg under fed and fasted conditions.

Conditions

Relative Bioavailability; AUC; Cmax; Pharmacokinetics

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Part 1: Treatment A-B-C-D

Subjects received a single dose of D1400147 (Treatment A: Omega-3-carboxylic acids 2000 mg uncoated capsules), D14000136 (Treatment B: Omega-3-carboxylic acids 2000 mg coated capsules coat 1), D14000137 (Treatment C: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) and Epanova® (Treatment D: Epanova capsules 1000 mg) under fasted condition.

Group Type: EXPERIMENTAL

D1400147

Intervention Type: DRUG

Treatment A

D14000136

Intervention Type: DRUG

Treatment B

D14000137

Intervention Type: DRUG

Treatment C

Epanova®

Intervention Type: DRUG

Treatment D

Part 2: Treatment A-B/C-D

Subjects received a single dose of D1400147 (Treatment A: Omega-3-carboxylic acids 2000 mg uncoated capsules), D14000136 (Treatment B: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) or D14000137 (Treatment C: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) and Epanova® (Treatment D: Epanova capsules 1000 mg) under fed condition.

Group Type: EXPERIMENTAL

D1400147

Intervention Type: DRUG

Treatment A

D14000136

Intervention Type: DRUG

Treatment B

D14000137

Intervention Type: DRUG

Treatment C

Epanova®

Intervention Type: DRUG

Treatment D

Interventions

D1400147

Treatment A

Intervention Type: DRUG

D14000136

Treatment B

Intervention Type: DRUG

D14000137

Treatment C

Intervention Type: DRUG

Epanova®

Treatment D

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Provision of signed and dated written informed consent prior to any study specific procedures.
• Healthy male and female (non-childbearing potential) subjects aged 18 to 55 years with suitable veins for cannulation or repeated venipuncture.
• Females must have a negative pregnancy test at screening and on admission to the clinical unit, must not be lactating and must be of non-childbearing potential, confirmed at screening by fulfilling one of the following criteria:

• Post-menopausal, defined as amenorrhea for at least 12 months or more following cessation of all exogenous hormonal treatments, and follicle-stimulating hormone (FSH) levels in the post-menopausal range.
• Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy or bilateral salpingectomy or tubal ligation.
• Have a body mass index (BMI) between 18.5 and 29.9 kg/m2 inclusive and weigh at least 50 kg and no more than 100 kg inclusive.

Exclusion Criteria

• History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the potential subject at risk because of participation in the study, or influences the results or the potential subject's ability to participate in the study.
• History or presence of gastrointestinal, hepatic or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
• Current smokers or those who have smoked or used nicotine products within the previous 3 months.
• Consumption of poppy seeds within 7 days of first administration of IMP.
• Consumption of fish within 7 days prior to admission to the clinical unit.
• Used fish oil, other omega-3 fatty acids (EPA and/or DHA) containing supplements within 1 month of admission to the clinical unit.
• Have a known sensitivity or allergy to soybeans, fish and/or shellfish.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ronald Goldwater, Dr.

Role: PRINCIPAL_INVESTIGATOR

PAREXEL Early Phase Clinical Unit Baltimore, 3001 S. Hanover St., Baltimore, MD 21225, United States of America

Locations

Research Site

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

D5884C00003

Identifier Type: -

Identifier Source: org_study_id