Study to Assess Drug Concentrations in Plasma of Different Extended-release Formulations of AZD1305

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the pharmacokinetics of different extended-release formulations of AZD1305 when given as single and multiple oral doses to healthy male volunteers.

Official Title
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A Phase I, Randomised, Open, Single-centre Study to Evaluate the Pharmacokinetics of Different Extended-release Formulations of AZD1305 When Given as Single and Repeated Oral Doses to Healthy Male Volunteers

Conditions
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Healthy

Intervention / Treatment
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* Drug: AZD1305
* Drug: AZD1305
* Drug: AZD1305


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provision of signed, written and dated informed consent prior to any study specific procedures. Body mass index (BMI) between 19 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg. Exclusion Criteria: History or presence of any clinically significant disease or disorder in the opinion of the investigator. Use of nicotine in the last 4 weeks before screening and not more than 7 cigarettes per week (equivalent to 1 nicotine patch or 7 nicotine gums per week) before then. There will be no smoking until follow-up visit. Any clinically relevant abnormal findings in physical examination, clinical chemistry, haematology, urinalysis, vital signs or ECG at baseline in the opinion of the investigator.

Ages Eligible for Study
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Minimum Age: 18 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part A: 3 way crossover<br>AZD1305: ER test formulation 1 (w/wo food) and reference formulation | Drug: AZD1305<br>* Single Oral Dose, ER formulation 1<br>|
| Experimental: Part B1: single arm<br>AZD1305: ER test formulation 1 | Drug: AZD1305<br>* ER formulation 1, bid for 5 days<br>|
| Experimental: Part B2: 3 way crossover<br>AZD1305: ER test formulation 2 (w/wo food) and reference formulation | Drug: AZD1305<br>* Single Oral Dose, ER formulation 2<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic variables of AZD1305 by assessment of drug concentrations in plasma |  | From predose until 48 hours post last dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events, ECG variables, vital signs, physical examination, laboratory variables and weight |  | Frequent safety measurements during the study, from screening period to follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Phase 1, healthy volunteer, male, pharmacokinetics, AZD1305