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

AstraZeneca24 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Type 2 Diabetes

Interventions

AZD5658DRUG

oral suspension, escalating single doses

PlaceboDRUG

oral suspension,single doses

Eligibility

Sex: ALLMin age: 20 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Research Site

Chula Vista, California, United States

Outcomes

Primary Outcomes

To investigate the safety and tolerability of AZD5658 following oral administration of single ascending doses and to estimate the maximum tolerated dose (MTD).

Time frame: AEs-, blood pressure and pulse during study days. Safety labs - day -1 to day 4; ECG - days 1, 2 and 3

Secondary Outcomes

To investigate the pharmacokinetics of AZD5658 after single ascending oral doses in type 2 diabetes mellitus patients.

Time frame: 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)

Time frame: Plasma glucose and serum insulin determined on Day -1 through Day 4

Effect of fasting on the pharmacokinetics and explore the pharmacodynamics of AZD5658.

Data from ClinicalTrials.gov

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