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

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00886366
• Other study ID #: D1920C00001
• Status: Terminated
• Phase: Phase 1
• First received: April 17, 2009
• Last updated: December 6, 2010
• Start date: April 2009
• Est. completion date: September 2009

Study information

• Verified date: December 2010
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationSweden: Medical Products AgencySweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 26
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 40 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Type 2 Diabetes

Intervention

Drug:
• AZD6714
Oral single doses a-h suspension
• Placebo
Oral single doses suspension
• AZD6714
Oral single doses a-d suspension
• AZD6714
Oral single doses d and g suspension

Locations

Country	Name	City	State
Sweden	Research Site	Goteborg

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Pharmacokinetic variables		Blood samples taken repeatedly during 24 hours on study day sessions.	No
Secondary	Pharmacodynamic variables (P-Glucose, S-Insulin and C-peptide)		Blood samples taken repeatedly during 24 hours on study day sessions.	No