AZD1305 Single and Multiple Ascending Dose Study in Healthy Japanese and Caucasian Subjects

Study Overview
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Brief Summary
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This is a phase I, single-blind, randomized, placebo-controlled single and repeated ascending dose study to assess the safety, tolerability and pharmacokinetics with oral doses of AZD1305 extended-release capsules in healthy male Japanese and Caucasian subjects. Three (or four if needed) dose levels will be given to Japanese subjects and one of the doses will also be given to Caucasian subjects.

Official Title
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A Single-center, Single-blind, Randomized, Placebo-controlled, Phase I Study to Assess the Safety, Tolerability and Pharmacokinetics After Single and Multiple Ascending Oral Doses of AZD1305 Extended-release Capsules in Healthy Male Japanese and Caucasian Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: AZD1305
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy Japanese and Caucasian male subjects 20 to 45 years of age inclusive Body weight between 50 and 85 kg, inclusive, with a Body Mass Index (BMI) ≥19 to ≤ 27 kg/m2 Exclusion Criteria: Clinically significant illness, surgical procedure or trauma, within two weeks preceding the pre-entry visit until first administration of IP, as judged by the investigator History of clinically significant gastrointestinal, mental, cardiac, renal or hepatic disorder, or other significant disease as judged by the investigator Habitual smoker (daily use) of tobacco or daily use of nicotine-containing products

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1, AZD1305<br> | Drug: AZD1305<br>* single and multiple oral doses, extended-release capsule<br>|
| Placebo Comparator: 2, Placebo<br> | Drug: Placebo<br>* single and multiple oral doses, capsule<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events, ECG variables, vital signs, physical examination, laboratory variables, body temperature and weight |  | During the study, from screening period to follow-up, 50 days approximately | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic variables of AZD1305 by assessment of drug concentrations in plasma and urine after single and repeated oral doses |  | From predose until 48 hrs post last dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Phase I, Japanese healthy volunteer, AZD1305, Japanese and Caucasian