A Randomized, Single-Blind, Placebo-Controlled, Single-Centre, Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Multiple Ascending Oral Doses of AZD1656 in T2DM Subjects

AstraZeneca1 site in 1 country52 target enrollmentAugust 2008

InterventionsAZD1656

Overview

Phase: Phase 1
Intervention: AZD1656
Conditions: Type 2 Diabetes
Sponsor: AstraZeneca
Enrollment: 52
Locations: 1
Primary Endpoint: Safety variables (AE, BP, pulse, plasma glucose, laboratory variables and ECG)
Status: Completed
Last Updated: 15 years ago

The purpose of this study is to assess safety and tolerability of AZD1656 after multiple repeated oral doses in patients with type 2 diabetes

Registry

clinicaltrials.gov

Start Date

August 2008

End Date

April 2009

Last Updated

15 years ago

Study Type

Interventional

Study Design

Factorial

Sex

All

Sponsor

•Male or surgically sterile female of non-childbearing potential (post-menopausal, ie natural or induced menopause with last menstruation \>1 year ago and LH and FSH in the post-menopausal range, and/or have undergone hysterectomy and/or bilateral oophorectomy
•Diagnosed diabetes Mellitus patients treated with diet and exercise alone or with up to two oral anti-diabetic drugs. Stable glycemic control indicated by no changed treatment within 3 months prior to enrollment
•HbA1c ≤10.5 % at screening (HbA1c value according to international DCCT standard)

•Clinically significant illness or clinically relevant trauma, as judged by the investigator, within two weeks before the first administration of the IP
•History ischemic heart disease, stroke, transitorisk ischemic attack or symptomatic peripheral vascular disease
•Clinically significant abnormalities in clinical chemistry, hematology, or urinalysis results. Positive test of Hepatitis B surface antigen, antibodies to HIV virus and antibodies to Hepatitis C virus

3 (alt.4) gradually increasing repeated oral doses of AZD1656 given to 3 (alt.4) groups (6 on active and 2 on placebo in each group)

Intervention: AZD1656

Oral dose of AZD1656 titrated during 3 days to a tolerable dose (15 on active and 5 on placebo)

Intervention: AZD1656

Safety variables (AE, BP, pulse, plasma glucose, laboratory variables and ECG)

Time Frame: Blood samples taken repeatedly during 24 hours on study day sessions

Pharmacokinetic variables(Blood samples taken repeatedly during 24 hours on study day sessions)
Pharmacodynamic variables(Blood samples taken repeatedly during 24 hours on study day sessions)