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
1 other identifier
interventional
36
1 country
1
Brief Summary
The purpose of this study is to assess safety and tolerability of AZD1656 after single ascending oral doses in Japanese healthy male subjects
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 healthy-volunteers
Started Aug 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2008
CompletedFirst Submitted
Initial submission to the registry
August 25, 2008
CompletedFirst Posted
Study publicly available on registry
August 26, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedDecember 3, 2010
December 1, 2010
4 months
August 25, 2008
December 2, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
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
Study Arms (1)
1
EXPERIMENTALAZD1656 in 6 increasing oral single doses given to 6 groups (5 on active and 1 on placebo in each group)
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (1)
Research Site
Glendale, California, United States
Related Publications (1)
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.
PMID: 22943931DERIVED
MeSH Terms
Interventions
Study Officials
- STUDY DIRECTOR
Klas Malmberg, MD, PhD Prof
AstraZeneca R&D Mölndal
- PRINCIPAL INVESTIGATOR
Mark Yen, MD
California Clinical Trials
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 25, 2008
First Posted
August 26, 2008
Study Start
August 1, 2008
Primary Completion
December 1, 2008
Study Completion
December 1, 2008
Last Updated
December 3, 2010
Record last verified: 2010-12