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

NCT ID: NCT00886366

Last Updated: 2010-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2009-09-30

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.

Detailed Description

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Conditions

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Type 2 Diabetes

Keywords

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Type II Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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1

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

Group Type EXPERIMENTAL

AZD6714

Intervention Type DRUG

Oral single doses a-h suspension

Placebo

Intervention Type DRUG

Oral single doses suspension

2

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

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

Oral single doses suspension

AZD6714

Intervention Type DRUG

Oral single doses d and g suspension

3

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

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

Oral single doses suspension

AZD6714

Intervention Type DRUG

Oral single doses a-d suspension

Interventions

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AZD6714

Oral single doses a-h suspension

Intervention Type DRUG

Placebo

Oral single doses suspension

Intervention Type DRUG

AZD6714

Oral single doses a-d suspension

Intervention Type DRUG

AZD6714

Oral single doses d and g suspension

Intervention Type DRUG

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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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AstraZeneca Pharmaceuticals

Principal Investigators

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Klas Malmberg, MD, PhD

Role: STUDY_DIRECTOR

AstraZeneca R&D Mölndal

Marianne Hartford

Role: PRINCIPAL_INVESTIGATOR

CPU Sahlgrenska University Hospital

Locations

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Research Site

Gothenburg, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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D1920C00001

Identifier Type: -

Identifier Source: org_study_id