Phase 1
Completed N=42
A Study to Investigate the Effect of Food on Pharmacokinetics of Total EPA and Total DHA of AZD0585 in Healthy Male Japanese Subjects
Healthy
Source: ClinicalTrials.gov NCT02372344 ↗
Enrolled (actual)
42
Serious AEs
0.0%
Results posted
May 2016
Primary outcomePrimary: The Effect of Food Timing (Fasting, Before Meal, and After Meal) on Pharmacokinetics (PK; AUC) of AZD0585 in Healthy Male Japanese. — 2.44; 2.66; 3.80; 0.299 milligram x hour /millilitre (mg⋅h/mL)
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Effect of Food Timing (Fasting, Before Meal, and After Meal) on Pharmacokinetics (PK; AUC) of AZD0585 in Healthy Male Japanese. |
2.44; 2.66; 3.80; 0.299; 0.444; 0.617 | — |
| PRIMARY The Effect of Food Timing (Fasting, Before Meal, and After Meal) on PK (Cmax) of AZD0585 in Healthy Male Japanese. |
78.5; 97.1; 221; 42.1; 52.4; 92.6 | — |
| PRIMARY The Effect of Food Timing (Fasting, Before Meal, and After Meal) on PK (AUC0-72) of AZD0585 in Healthy Male Japanese. |
1.53; 1.52; 2.76; 0.542; 0.533; 0.621 | — |
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.
Data sourced from ClinicalTrials.gov (NCT02372344). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.