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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01176097

Enrollment

Registered

2010-08-05

Start date

2010-07-31

Completion date

2011-02-28

Last updated

2012-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes

Keywords

First in man study evaluating AZD5658 in Type 2 Diabetics., Effect of fasting, Safety, Tolerability

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.

Interventions

DRUGAZD5658

oral suspension, escalating single doses

DRUGPlacebo

oral suspension,single doses

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

20 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026