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

Pharmacokinetics Clinical Trial

Official title:

A Randomized, Open-label, Single-center, Cross-over Study in Healthy Subjects to Assess the Relative Bioavailability of EPA and DHA Delivered by Three New Capsule Formulation Prototypes in Relation to the Current Epanova® Capsule Under Fasting (Part 1) and Fed (Part 2) Conditions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02359045
• Other study ID #: D5884C00003
• Status: Completed
• Phase: Phase 1
• First received: February 4, 2015
• Last updated: July 30, 2015
• Start date: February 2015
• Est. completion date: July 2015

Study information

• Verified date: July 2015
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 137
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• AUC,
• Cmax,
• Pharmacokinetics
• Relative Bioavailability,

Intervention

Drug:
• D1400147
Treatment A
• D14000136
Treatment B
• D14000137
Treatment C
• Epanova®
Treatment D

Locations

Country	Name	City	State
United States	Research Site	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate and extent of absorption of omega-3-carboxylic acids following single-dose oral administration of test formulation 1, 2 and 3 and reference formulation (Epanova®) under fed and fasted condition, by assessment of AUC, AUC(0-72) and Cmax	Comparison of the pharmacokinetic profile in terms of plasma concentration-time curve from time zero extrapolated to infinity (AUC), plasma concentration-time curve from time zero to 72 hours post-dose (AUC(0-72)) and maximum observed plasma concentration (Cmax)	-12, -1 and 0 hours pre-dose and at 0.5, 1, 2, 3, 4, 5, 6, 7.5, 9, 12, 24, 36, 48 and 72 hours post-dose	No
Secondary	Rate and extent of absorption of omega-3-carboxylic acids following single-dose oral dosing of test formulation 1, 2 and 3 and reference formulation (Epanova®) in fed and fasted state, by assessment of AUClast, tmax, t½,?z, tlag, and ?z	Comparison of the pharmacokinetic profile in terms of plasma concentration-time curve from time zero to time of last quantifiable analyte concentration (AUClast), baseline concentration (C0), time to reach maximum observed concentration (tmax), lag-time (tlag -time delay between drug administration and first observed concentration above lower limit of quantification in plasma), half-life associated with terminal slope (?z) of a semi-logarithmic concentration-time curve (t½,?z) and terminal elimination rate constant (?z).	-12, -1 and 0 hours pre-dose and at 0.5, 1, 2, 3, 4, 5, 6, 7.5, 9, 12, 24, 36, 48 and 72 hours post-dose	No
Secondary	Safety of omega-3-carboxylic acids by assessing adverse events	To assess the safety of single doses of Epanova® and the omega-3-carboxylic acids test formulations in healthy subjects	At pre-defined timepoints from screening until follow-up	Yes
Secondary	Safety of omega-3-carboxylic acids by assessing blood pressure	To assess the safety of single doses of Epanova® and the omega-3-carboxylic acids test formulations in healthy subjects	At pre-defined timepoints from screening until follow-up	Yes
Secondary	Safety of omega-3-carboxylic acids by assessing pulse	To assess the safety of single doses of Epanova® and the omega-3-carboxylic acids test formulations in healthy subjects	At pre-defined timepoints from screening until follow-up	Yes
Secondary	Safety of omega-3-carboxylic acids by assessing electrocardiogram	To assess the safety of single doses of Epanova® and the omega-3-carboxylic acids test formulations in healthy subjects	At pre-defined timepoints from screening until follow-up	Yes
Secondary	Safety of omega-3-carboxylic acids by assessing laboratory variables	To assess the safety of single doses of Epanova® and the omega-3-carboxylic acids test formulations in healthy subjects	At pre-defined timepoints from screening until follow-up	Yes