To Assess Safety, Tolerability, Pharmacokinetics/Pharmacodynamics and the Effect of Fasting After Single Oral Doses of AZD5658 in Type 2 Diabetes

Phase 1

Completed

• Conditions: Type 2 Diabetes
• Interventions: Drug: AZD5658; Drug: Placebo

• Registration Number: NCT01176097
• Lead Sponsor: AstraZeneca

Brief Summary

The purpose of this study is to investigate the safety and tolerability of AZD5658 following ascending single oral doses in Type 2 Diabetics. It will also estimate the maximum tolerated dose.

Detailed Description

This is a randomized, single-blind, placebo-controlled, single-center, phase 1 study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and the effect of fasting after single ascending oral doses of AZD5658 in type 2 diabetes mellitus patients.

Study Timeline

• Study Start: 2010-07
• Study First Submitted: 2010-07-19
• Study First Submitted QC: 2010-08-04
• Study First Posted: 2010-08-05
• Primary Completion: 2011-02
• Study Completion: 2011-02
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-01
• Last Update Posted: 2012-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Patients must be of non-childbearing potential.
• Body mass index between greater than or equal to 19 and less than or equal to 40 kg/m2
• Patients with confirmed Type 2 Diabetes diagnosis for at least 1 year and treated with Metformin

Exclusion Criteria

• Clinically significant illness or clinically relevant trauma within 2 weeks before the first administration of the IP
• Participation in another clinical study during the last 30 days prior to enrollment
• Significant cardiovascular event within the last 6 months prior to enrollment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
6 - 8 cohorts	AZD5658	2 patients in each cohort will receive placebo
6 - 8 cohorts	Placebo	2 patients in each cohort will receive placebo

Primary Outcome Measures

Name	Time	Method
To investigate the safety and tolerability of AZD5658 following oral administration of single ascending doses and to estimate the maximum tolerated dose (MTD).	AEs-, blood pressure and pulse during study days. Safety labs - day -1 to day 4; ECG - days 1, 2 and 3

Secondary Outcome Measures

Name	Time	Method
To investigate the pharmacokinetics of AZD5658 after single ascending oral doses in type 2 diabetes mellitus patients.	Venous blood samples for the determination of concentrations of AZD5658 in plasma will be taken predose and at various times up to 72 hours postdose
Pharmacodynamics (plasma glucose and serum insulin)	Plasma glucose and serum insulin determined on Day -1 through Day 4
Effect of fasting on the pharmacokinetics and explore the pharmacodynamics of AZD5658.

Trial Locations

Locations (1)

Research Site; 🇺🇸 Chula Vista, California, United States