A Study to Evaluate Safety and Tolerability After Oral Dosing of AZD1656 in Healthy Volunteers
A Randomized, Single-Blind, Placebo-Controlled, Single-Centre, Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Food Interaction After Single Ascending Oral Doses of AZD1656 in Healthy Male Subjects
1 other identifier
interventional
32
1 country
1
Brief Summary
The purpose of this study is to assess safety and tolerability of AZD1656 after single ascending oral doses in 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
Started Jul 2008
Shorter than P25 for phase_1 healthy
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
July 1, 2008
CompletedFirst Submitted
Initial submission to the registry
July 29, 2008
CompletedFirst Posted
Study publicly available on registry
August 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2008
CompletedDecember 3, 2010
December 1, 2010
2 months
July 29, 2008
December 2, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety variables (AE's, BP, pulse, lab variables, and 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 (2)
1
EXPERIMENTAL8 increasing oral single doses given to 8 groups (3 on active and 1 on placebo in each group)
2
EXPERIMENTAL2 oral doses of AZD1656 given to 2 groups together with food
Interventions
Eligibility Criteria
You may qualify if:
- Provision of informed consent
- 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 2 weeks before the first administration of the Investigational Product
- 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
Philadelphia, Pennsylvania, 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
AstraZeneca R&D Mölndal
- PRINCIPAL INVESTIGATOR
Sylvan Hurewitz, MD
AstraZeneca CPU, Philadelphia, PA
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
July 29, 2008
First Posted
August 1, 2008
Study Start
July 1, 2008
Primary Completion
September 1, 2008
Study Completion
September 1, 2008
Last Updated
December 3, 2010
Record last verified: 2010-12