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

Healthy Clinical Trial

Official title:

A Phase I, Single Centre, Randomized, Open-Label, Three-Period Crossover Study to Investigate the Effect of Food on Pharmacokinetics of Total EPA and Total DHA With a Single 4 g Dose of AZD0585 in Healthy Male Japanese Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02372344
• Other study ID #: D5884C00004
• Status: Completed
• Phase: Phase 1
• First received: February 5, 2015
• Last updated: May 26, 2015
• Start date: March 2015
• Est. completion date: May 2015

Study information

• Verified date: May 2015
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 45 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Japan	Research Site	Fukuoka-shi

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The effect of food timing (fasting, before meal, and after meal) on pharmacokinetics (PK; AUC) of AZD0585 in healthy male Japanese.	To investigate the effect of food timing on pharmacokinetics (PK) of single dose of 4 g AZD0585 in healthy male Japanese by assessing plasma concentrations of total eicosapentaenoic acid (EPA) and total docosahexaenoic acid (DHA), and PK parameters over time under the three proposed conditions (fasting, before meal, and after meal).	Blood samples will be collected from pre-dose (Day -1 in visit 2) to Day 38 in visit 4.	No
Primary	The effect of food timing (fasting, before meal, and after meal) on pharmacokinetics (PK; Cmax) of AZD0585 in healthy male Japanese.	To investigate the effect of food timing on pharmacokinetics (PK) of single dose of 4 g AZD0585 in healthy male Japanese by assessing plasma concentrations of total eicosapentaenoic acid (EPA) and total docosahexaenoic acid (DHA), and PK parameters over time under the three proposed conditions (fasting, before meal, and after meal).	Blood samples will be collected from pre-dose (Day -1 in visit 2) to Day 38 in visit 4.	No
Primary	The effect of food timing (fasting, before meal, and after meal) on pharmacokinetics (PK; AUC0-72) of AZD0585 in healthy male Japanese.	To investigate the effect of food timing on pharmacokinetics (PK) of single dose of 4 g AZD0585 in healthy male Japanese by assessing plasma concentrations of total eicosapentaenoic acid (EPA) and total docosahexaenoic acid (DHA), and PK parameters over time under the three proposed conditions (fasting, before meal, and after meal).	Blood samples will be collected from pre-dose (Day -1 in visit 2) to Day 38 in visit 4.	No
Secondary	The effect of food timing (fasting, before meal, and after meal) on tolerability and safety of AZD0585 as measured by adverse event(AE)	To investigate the effect of food timing on tolerability and safety of single dose of 4 g AZD0585 in healthy male Japanese by assessing AEs.	Adverse event will be collected from randomization(Day1) to visit 5 (Day 41).	Yes
Secondary	The effect of food timing (fasting, before meal, and after meal) on tolerability and safety of AZD0585 as measured by laboratory tests	To investigate the effect of food timing on tolerability and safety of single dose of 4 g AZD0585 in healthy male Japanese by assessing laboratory tests (clinical chemistry, haematology, urinalysis).	Clinical chemistry will be collected from visit 1 to visit 5 (Day 41).	Yes
Secondary	The effect of food timing (fasting, before meal, and after meal) on tolerability and safety of AZD0585 as measured by vital signs	To investigate the effect of food timing on tolerability and safety of single dose of 4 g AZD0585 in healthy male Japanese by assessing vital signs (blood pressure [BP], pulse rate, body temperature).	Vital signs will be collected from visit 1 to visit 5 (Day 41).	Yes
Secondary	The effect of food timing (fasting, before meal, and after meal) on tolerability and safety of AZD0585 as measured by physical findings	To investigate the effect of food timing on tolerability and safety of single dose of 4 g AZD0585 in healthy male Japanese by assessing physical findings.	Physical findings will be collected from visit 1 to visit 5 (Day 41)	Yes
Secondary	The effect of food timing (fasting, before meal, and after meal) on tolerability and safety of AZD0585 as measured by electrocardiograms (ECGs)	To investigate the effect of food timing on tolerability and safety of single dose of 4 g AZD0585 in healthy male Japanese by assessing ECGs.	ECGs will be collected from visit 1 to visit 5 (Day 41)	Yes