Phase I Study in Healthy Volunteers to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD4017 After Repeated Ascending Oral Doses

Study Overview
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Brief Summary
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The primary aim of this study is to investigate the safety and tolerability of AZD4017 when given as multiple oral ascending doses to healthy volunteers. This will be done by comparing the effect of AZD4017 to placebo. The study will aslo investigate the absorption, distribution and disappearance of AZD4017 in the body. Information about plasma concentrations of AZD4017 vs time after dose intake will also be collected and some measures of pharmacokinetics versus pharmacodynamics will be included. 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 Volunteers to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD4017 After Repeated Ascending Oral Doses

Conditions
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Diabetes Mellitus Type 2

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 30 kg/m2 Subjects must be willing to use barrier methods of contraception Exclusion Criteria: History of any clinically 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 liver enzymes (ASAT, ALAT) and muscle enzymes (CK).

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

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 75mg od) | Drug: AZD4017<br>* ascending multiple doses(start dose 75mg od), oral suspension<br>|
| Placebo Comparator: 2<br>Placebo | Drug: Placebo<br> <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 measured predose and then repeatedly during the study | 

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 concentration will be taken predose and repeatedly during the study. | 
| Laboratory screen to evaluate effect on metabolic variables |  | Blood samples will be taken pre-dose and repeatedly during the study | 
| Pharmacodynamic measurements allowing to assess AZD4017 effect in different tissues |  | Baseline and repeatedly after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Safety and tolerability