To Assess Safety, Tolerability, Pharmacokinetics/Pharmacodynamics and the Effect of Fasting After Single Oral Doses of AZD5658 in Type 2 Diabetes

Study Overview
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Brief Summary
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The purpose of this study is to investigate the safety and tolerability of AZD5658 following ascending single oral doses in Type 2 Diabetics. It will also estimate the maximum tolerated dose.

Detailed Description
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This is a randomized, single-blind, placebo-controlled, single-center, phase 1 study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and the effect of fasting after single ascending oral doses of AZD5658 in type 2 diabetes mellitus patients.

Official Title
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A Randomized, Single-Blind, Placebo-Controlled, Single-Center, Phase 1 Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and the Effect of Fasting After Single Ascending Oral Doses of AZD5658 in Type 2 Diabetes Mellitus Patients

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Drug: AZD5658
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients must be of non-childbearing potential. Body mass index between greater than or equal to 19 and less than or equal to 40 kg/m2 Patients with confirmed Type 2 Diabetes diagnosis for at least 1 year and treated with Metformin Exclusion Criteria: Clinically significant illness or clinically relevant trauma within 2 weeks before the first administration of the IP Participation in another clinical study during the last 30 days prior to enrollment Significant cardiovascular event within the last 6 months prior to enrollment

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 6 - 8 cohorts<br>6 patients in each cohort will receive AZD5658 | Drug: AZD5658<br>* oral suspension, escalating single doses<br>Drug: Placebo<br>* oral suspension,single doses<br>|
| Placebo Comparator: 6 - 8 cohorts<br>2 patients in each cohort will receive placebo | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To investigate the safety and tolerability of AZD5658 following oral administration of single ascending doses and to estimate the maximum tolerated dose (MTD). |  | AEs-, blood pressure and pulse during study days. Safety labs - day -1 to day 4; ECG - days 1, 2 and 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To investigate the pharmacokinetics of AZD5658 after single ascending oral doses in type 2 diabetes mellitus patients. |  | Venous blood samples for the determination of concentrations of AZD5658 in plasma will be taken predose and at various times up to 72 hours postdose | 
| Pharmacodynamics (plasma glucose and serum insulin) |  | Plasma glucose and serum insulin determined on Day -1 through Day 4 | 
| Effect of fasting on the pharmacokinetics and explore the pharmacodynamics of AZD5658. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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First in man study evaluating AZD5658 in Type 2 Diabetics., Effect of fasting, Safety, Tolerability