A Study to Investigate the Effect of Food on Pharmacokinetics of Total EPA and Total DHA of AZD0585 in Healthy Male Japanese Subjects

NCT ID: NCT02372344

Last Updated: 2016-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2015-05-31

Brief Summary

The purpose of this study is to assess the effect of food timing on pharmacokinetics (PK) of AZD0585 and the effect of food timing on tolerability and safety of AZD0585 in healthy male Japanese subjects.

Detailed Description

This study is an open-label, randomized, cross-over design with three single-dose treatment periods and a washout of at least 10 days in between each treatment visit. The study period consists of 5 visits to the study centre: Visit 1 (enrolment), Visit 2 (first single-dose treatment), Visit 3 (second single-dose treatment), Visit 4 (third single-dose treatment) and Visit 5 (follow-up).

Target subject population is healthy male Japanese subjects aged 20-45 years. Following an overnight fast of at least 10 hours, a single dose of 4 g AZD0585 will be administered on 3 separate occasions (fasting, before meal, and after meal) in a randomized crossover fashion with different food restrictions.

Conditions

Healthy

Study Design

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

Study Groups

Fasting

Each subject will receive a single oral dose of 4 g AZD0585 on Day 1 of Visits 2, 3, and 4. Each dose will be administered at the end of a 10-hour fast.

Group Type: EXPERIMENTAL

AZD0585

Intervention Type: DRUG

Following an overnight fast of at least 10 hours, a single dose of 4 g AZD0585 will be administered on 3 separate occasions (fasting, before meal, and after meal) in a randomized crossover fashion with different food restrictions.

Before meal

Each subject will receive a single oral dose of 4 g AZD0585 on Day 1 of Visits 2, 3, and 4. Each dose will be administered before consumption of a low calorie, low-fat breakfast (within 30 minutes before starting food intake).

Group Type: EXPERIMENTAL

AZD0585

Intervention Type: DRUG

Following an overnight fast of at least 10 hours, a single dose of 4 g AZD0585 will be administered on 3 separate occasions (fasting, before meal, and after meal) in a randomized crossover fashion with different food restrictions.

After meal

Each subject will receive a single oral dose of 4 g AZD0585 on Day 1 of Visits 2, 3, and 4. Each dose will be administered after consumption of a low calorie, low-fat breakfast (within 30 minutes after starting food intake).

Group Type: EXPERIMENTAL

AZD0585

Intervention Type: DRUG

Following an overnight fast of at least 10 hours, a single dose of 4 g AZD0585 will be administered on 3 separate occasions (fasting, before meal, and after meal) in a randomized crossover fashion with different food restrictions.

Interventions

AZD0585

Following an overnight fast of at least 10 hours, a single dose of 4 g AZD0585 will be administered on 3 separate occasions (fasting, before meal, and after meal) in a randomized crossover fashion with different food restrictions.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Healthy Japanese male, 20 to 45 years of age (inclusive).
• Body mass index (BMI) ≥ 18.5 and ≤ 25 (kg/m2).
• Medically healthy with clinically insignificant screening results (e.g., laboratory profiles, medical histories, ECGs, physical findings). Hemoglobin level must be ≥ the lower limit of study centre reference range. 12-Lead ECG with QT interval corrected for heart rate using Fridericia's formula (QTcF) should be > 340 msec and < 450 msec.
• No habitual use of drug(s) and tobacco/nicotine-containing products for a minimum of 3 months prior to first dosing.
• Subjects must be willing and able to give written informed consent by signing an Institutional Review Board (IRB)-approved Informed Consent Form prior to admission to this study and follow the restrictions and procedures outlined for the study.

Exclusion Criteria

• Past history of psychological or physical disorder which may affect the objectives of this study, in the opinion of the PI.
• An individual who has abnormal laboratory values (ie, suggesting hepatic, renal, cardiovascular or endocrine disorders or diabetes mellitus), or an inappropriate current or past medical history for participation based on the decision of the PI.
• A history or presence of significant cardiovascular, pulmonary, hepatic, renal, haematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic or psychiatric disease.
• Had used fish oil, other EPA- and/or DHA-containing supplements within 2 months prior to first admission day.
• Have serum (or plasma) EPA and/or DHA concentrations exceeding the upper limit of reference range for the "fatty acids profile, four-fraction" test, determined at Visit 1.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kei Sakamoto, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Sugioka Memorial Hospital, Medical Co. LTA

Torbjörn Lundström, MD

Role: STUDY_DIRECTOR

AstraZeneca

Locations

Research Site

Fukuoka, , Japan

Countries

Japan

References

Shimada H, Nilsson C, Noda Y, Kim H, Lundstrom T, Yajima T. Effects of Food on the Pharmacokinetics of Omega-3-Carboxylic Acids in Healthy Japanese Male Subjects: A Phase I, Randomized, Open-label, Three-period, Crossover Trial. J Atheroscler Thromb. 2017 Sep 1;24(9):980-987. doi: 10.5551/jat.38737. Epub 2017 Mar 24.

Reference Type: DERIVED

PMID: 28344197 (View on PubMed)

Other Identifiers

D5884C00004

Identifier Type: -

Identifier Source: org_study_id