Single Ascending Dose Study With Healthy Male Volunteers and Type II Diabetic Patients

Study Overview
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Brief Summary
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The purpose of this study is to assess safety and tolerability of AZD6714 after single ascending oral doses in healthy male subjects and type 2 diabetic patients.

Official Title
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A Randomised, Single-Blind, Placebo-Controlled, Single-Centre, Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Food Interaction After Single Ascending Oral Doses of AZD6714 in Healthy Male Volunteers and Male Type II Diabetic Patients

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Drug: AZD6714
* Drug: Placebo
* Drug: AZD6714
* Drug: AZD6714


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Part A,Healthy male subjects, aged between ≥20 and ≤40 years. Part B,Male T2DM patients, aged between ≥20 and ≤65 years. Treatment with metformin as single therapy for T2DM for at least 30 days prior to enrollment Exclusion Criteria: Part A,Clin sign illness or clin relevant trauma, as judged by the investigator, within 2 weeks before the first administration of the IP. Part A Clin sign abnormalities in clinical chemistry, haematology, or urinalysis results as judged by the investigator Part B, History of ischemic heart disease, symptomatic heart failure, stroke, transitory ischemic attack or symptomatic peripheral vascular disease. Any clinically significant abnormality identified on physical examination, laboratory tests or ECG, which in the judgment of the investigator would compromise the patient's safety or successful participation.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>AZD6714 in 8 increasing oral single doses a-h given to 8 groups (3 on active and 1 on placebo in each group) | Drug: AZD6714<br>* Oral single doses a-h suspension<br>Drug: Placebo<br>* Oral single doses suspension<br>|
| Experimental: 2<br>2 oral single doses d and g suspensions of AZD6714 given to 2 groups (3+1) together with food | Drug: Placebo<br>* Oral single doses suspension<br>Drug: AZD6714<br>* Oral single doses d and g suspension<br>|
| Experimental: 3<br>Two increasing oral doses of AZD6714 and one placebo given to 2 groups with 3 type 2 diabetic patients. | Drug: Placebo<br>* Oral single doses suspension<br>Drug: AZD6714<br>* Oral single doses a-d suspension<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety variables (AE, BP, pulse, plasma glucose, laboratory variables and ECG) |  | AEs will be collected during the whole study period (1-3 months). The other variables will be measured repeatedly during 24 hours on the study day sessions | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic variables |  | Blood samples taken repeatedly during 24 hours on study day sessions. | 
| Pharmacodynamic variables (P-Glucose, S-Insulin and C-peptide) |  | Blood samples taken repeatedly during 24 hours on study day sessions. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type II Diabetes