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

AstraZeneca

Status and phase: Terminated; Phase 1

Conditions: Type 2 Diabetes

Treatments: Drug: AZD6714; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00886366

D1920C00001

Details and patient eligibility

About

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.

Enrollment: 26 estimated patients

Sex: All

Ages: 20 to 40 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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26 participants in 3 patient groups

1

Experimental group

Description:

AZD6714 in 8 increasing oral single doses a-h given to 8 groups (3 on active and 1 on placebo in each group)

Treatment:

Drug: Placebo

Drug: AZD6714

Drug: AZD6714

Drug: AZD6714

2

Experimental group

Description:

2 oral single doses d and g suspensions of AZD6714 given to 2 groups (3+1) together with food

Treatment:

Drug: Placebo

Drug: AZD6714

Drug: AZD6714

Drug: AZD6714

3

Experimental group

Description:

Two increasing oral doses of AZD6714 and one placebo given to 2 groups with 3 type 2 diabetic patients.

Treatment:

Drug: Placebo

Drug: AZD6714

Drug: AZD6714

Drug: AZD6714