A Study to Evaluate Safety and Tolerability After Single Oral Dosing of AZD1656 in Japanese Healthy Volunteers

A Randomised, Single-Blind, Placebo-Controlled, Single-Centre, Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Single Ascending Oral Doses of AZD1656 in Japanese Healthy Male Volunteers

The purpose of this study is to assess safety and tolerability of AZD1656 after single ascending oral doses in Japanese healthy male subjects

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: AZD1656

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Glendale, California, United States
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Healthy Japanese males aged ≥20 and ≤40 years of age
• Clinically normal physical findings and laboratory values as judged by the investigator including negative test of Hepatitis B surface antigen, antibodies to HIV virus and antibodies to Hepatitis C virus

Exclusion Criteria:

• Clinically significant illness or clinically relevant trauma, as judged by the investigator, within two weeks before the first administration of the IP
• History of psychiatric or somatic disease/condition that may interfere with the objectives of the study, as judged by the investigator.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: FACTORIAL
• Masking: SINGLE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 1; AZD1656 in 6 increasing oral single doses given to 6 groups (5 on active and 1 on placebo in each group)	Drug: AZD1656; Dose escalation of oral single doses of AZD1656 to achieve maximal tolerated dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Safety variables (AEs, blood pressure (BP), pulse, safety laboratory variables and electrocardiography (ECG)	Safety variables taken repeatedly during 24 hours on study day sessions

Secondary Outcome Measures

Outcome Measure	Time Frame
Pharmacokinetic variables	Pharmacokinetic variables taken repeatedly during 24 hours on study day sessions
Pharmacodynamic variables	Blood samples taken repeatedly during 24 hours on study day sessions

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Study Director: Klas Malmberg, MD, PhD Prof, AstraZeneca R&D Mölndal

Publications and helpful links

General Publications

• Ericsson H, Roshammar D, Wollbratt M, Heijer M, Persson M, Ueda S, Leonsson-Zachrisson M, Norjavaara E. Tolerability, pharmacokinetics, and pharmacodynamics of the glucokinase activator AZD1656, after single ascending doses in healthy subjects during euglycemic clamp. Int J Clin Pharmacol Ther. 2012 Nov;50(11):765-77. doi: 10.5414/CP201747.

Study record dates

Study Major Dates

• Study Start: August 1, 2008
• Primary Completion (ACTUAL): December 1, 2008
• Study Completion (ACTUAL): December 1, 2008

Study Registration Dates

• First Submitted: August 25, 2008
• First Submitted That Met QC Criteria: August 25, 2008
• First Posted (ESTIMATE): August 26, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): December 3, 2010
• Last Update Submitted That Met QC Criteria: December 2, 2010
• Last Verified: December 1, 2010

More Information

Terms related to this study

• Keywords: volunteers; Japanese; healthy
• Other Study ID Numbers: D1020C00003