A Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics After High Single Ascending Oral Doses of AZD1656 in T2DM Patients

• Sponsor: AstraZeneca (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01221545
• Collaborator: (none)
• Enrollment: 24
• Location: 1
• Arms: 2
• Duration (Months): 3
• Patients Per Site Per Month: 7.9

Study Details

Study Description

Brief Summary

The purpose of this study is to investigate safety and tolerability after high Single Ascending Oral Doses of AZD1656.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes Mellitus	Drug: AZD1656; Drug: Placebo	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Single (Participant)
• Primary Purpose: Basic Science
• Official Title: A Randomised, Single-Blind, Placebo-Controlled, Single-Centre Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics After High Single Ascending Oral Supratherapeutic Doses of AZD1656 in Male Type 2 Diabetes Mellitus (T2DM) Patients
• Study Start Date: Oct 1, 2010
• Actual Primary Completion Date: Jan 1, 2011
• Actual Study Completion Date: Jan 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: A - AZD1656 AZD1656	Drug: AZD1656; 3 escalating dose levels are planned. Administration of the escalating doses of AZD1656 will be based on review of available safety from the previous dose.
Placebo Comparator: B - Placebo Placebo	Drug: Placebo; Placebo

Outcome Measures

Primary Outcome Measures

1. Primary Objective to assess the safety and tolerability of AZD1656, following oral administration of single ascending supratherapeutic doses of AZD1656 to patients with type 2 diabetes mellitus in a fasted state. [From screening until Follow up]

Secondary Outcome Measures

1. Secondary objective to evaluate the pharmacokinetics (AUC, Cmax, t1/2, CL/F) of AZD1656 and its metabolite following oral administration of single ascending supratherapeutic doses of AZD1656 [From pre-dose Day 1 to 48 hours after dose]

2. Secondary objective to evaluate glucose levels and insulin secretion in type 2 diabetes mellitus patients following oral administration of single ascending supratherapeutic doses of AZD1656 [Glucose levels from Day -1 to day 3]

3. Secondary objective to evaluate glucose levels and insulin secretion in type 2 diabetes mellitus patients following oral administration of single ascending supratherapeutic doses of AZD1656 [Insuline secretion from Day -1 to 2.]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 60 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Provision of signed and dated, written informed consent prior to any study specific procedures.

• Male, T2DM patients aged 20-60 years

• Treatment with 1 to 2 OADs as Therapy for T2DM for at least 30 days prior to enrollment

• Patients should not have been treated with glitazones within 6 months prior to enrollment

• Male T2DM patients without known cardiovascular disease, with the exception of Grade 1 hypertension without secondary organ involvement (eg. grade 1 HT is allowed if no eye, kidney disease or LVH has been documented).

Exclusion Criteria:

• History of ischemic heart disease , heart failure, stroke, transitory ischemic attack or peripheral vascular disease.

• Prolonged QTcF>450 msec or shortened QTcF<350 msec or family history of long QT syndrome.

• Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG that may interfere with the interpretation of QTc interval changes.

• Systolic BP>159 mmHg or diastolic BP>99 mmHg at screening and on Day-1

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Site	Chula Vista	California	United States

Sponsors and Collaborators

• AstraZeneca

Investigators

• Principal Investigator: Linda Morrow, MD, Profil Institute for Clinical Research, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01221545
• Other Study ID Numbers: D1020C00044
• First Posted: Oct 15, 2010
• Last Update Posted: Feb 17, 2011
• Last Verified: Feb 1, 2011

• Keywords provided by , ,: Diabetes Mellitus
• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Feb 17, 2011