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

NCT00886366 | Terminated Phase 1

• 1 other identifier: D1920C00001
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type 2 Diabetes

Keywords

Type II Diabetes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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.

Study Arms (3)

1

EXPERIMENTAL

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; Drug: Placebo

2

EXPERIMENTAL

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

Drug: Placebo; Drug: AZD6714

3

EXPERIMENTAL

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

Drug: Placebo; Drug: AZD6714

Interventions

AZD6714 DRUG

Oral single doses a-h suspension

1

Placebo DRUG

Oral single doses suspension

1; 2; 3

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Gothenburg, Sweden

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Klas Malmberg, MD, PhD

  AstraZeneca R&D Mölndal

  STUDY DIRECTOR

• Marianne Hartford

  CPU Sahlgrenska University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 17, 2009
• First Posted: April 22, 2009
• Study Start: April 1, 2009
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: December 7, 2010

Record last verified: 2010-12

Locations

SE (1)