Study to Investigate Safety and Tolerability Single Ascending Doses of AZD4017.

Study Overview
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Brief Summary
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The primary aim of this study is to investigate the safety and tolerabilty of AZD4017 when given as single oral ascending doses to Japanese healthy male volunters. This will be done by comparing the effect of AZD4017 to placebo. The study will aslo investigate the absorption, distrubution and disappearance of AZD4017 in the body. Information about plasma concentrations of AZD4017 vs time after dose intake will also be collected. The future indication for AZD4017 is planned to be Type 2 Diabetes Mellitus.

Official Title
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A Randomised, Single-Blind, Placebo-Controlled, Single-Centre Phase I Study in Healthy Japanese Male Volunteers to Assess the Safety, Tolerability and Pharmacokinetics of AZD4017 After Single Ascending Oral Doses

Conditions
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Healthy

Intervention / Treatment
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* Drug: AZD4017
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provision of signed written and dated informed consent BMI between 19 and 27 kg/m2 Subjects must be willing to use barrier methods of contraception Exclusion Criteria: History of any clinical significant disease Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of investigational product History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs Laboratory blood sample result showing elevated liverenzymes (ASAT, ALAT) and muscle enzymes (CK).

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

Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>AZD4017 in ascending doses (start dose 2mg) | Drug: AZD4017<br>* ascending single doses (start dose 2 mg), oral suspension<br>|
| Placebo Comparator: 2<br>Placebo | Drug: Placebo<br>* placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and Tolerability (Adverse events, vital signs, ECGs, physical examination, laboratory variables |  | The variables will be measure predose and the repeatedly during the following 47 hours after dosing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum plasma concentration (Cmax), time to Cmax (tmax), terminal half-life, area under the plasma concentration-time curve and the apparent oral plasma clearance (CL/F) |  | Blood samples for determination of AZD4017 concentartion will be taken predose and repeatedly during the 47 hours post dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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safety, tolerability, pharmacokinetics, AZD4017Japanese