Japanese Single and Multiple Ascending Dose, Safety, Tolerability, Pharmacokinetic (PK) & Pharmacodynamic (PD) Study of AZD7687

Study Overview
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Brief Summary
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This is a study in Japanese healthy volunteers to determine the safety and tolerability of the compound AZD7687. It will also assess how the body handles the drug and how it responds to the drug following single dose followed by multiple dosing over 7 days.

Official Title
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A Phase I, Single Centre, Single-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral AZD7687 After Administration of Single and Multiple Ascending Doses in Healthy Male Japanese Subjects

Conditions
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Type 2 Diabetes, Obesity

Intervention / Treatment
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* Drug: AZD7687


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Suitable veins for cannulation or repeated venipuncture Have a body mass index (BMI) between 19 and 35 kg/m2 and weigh at least 50 kg and no more than 90 kg Male subjects should be willing to use barrier contraception ie, condoms with spermicide, from the first day of dosing until 3 months after the last dose of investigational product Exclusion Criteria: History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study. History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of investigational product

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: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: AZD7687<br>* Oral suspension<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigate the safety and tolerability of AZD7687 following administration of single and multiple doses |  | From screening period to follow-up visit 45 days (Maximum). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the pharmacokinetics (PK) (plasma and urine) of AZD7687 and it´s glucuronic acid metabolite (AZ13128940) after single and multiple doses |  | Before dose and repeatedly to follow-up visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Phase 1, Type 2 diabetes, obesity, Japanese healthy volunteer, AZD7687