Study Stopped
Pre-Clinical Safety Tox Findings
This Study Will Assess the Safety and Tolerability of AZD8418 After Single Increasing Oral Doses
A Phase I, Single-center, Randomized, Double-blind, Placebo-controlled Single-ascending Dose, First Time Into Man Study to Assess the Safety, Tolerability, and Pharmacokinetics (Part A) and an Open-label Assessment of the Effect of Food on the Pharmacokinetics (Part B) of Orally Administered AZD8418
1 other identifier
interventional
40
1 country
1
Brief Summary
The main purpose of this study is to assess the safety and tolerability of AZD8418 after single increasing oral doses. Another purpose of this study is to evaluate the pharmacokinetics (also called PK - how the study drug enters and leaves the body and how your body acts on the study drug) of AZD8418. Part B of the study will assess the effect of food on the safety and pharmacokinetics of AZD8418.
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 Nov 2009
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
November 1, 2009
CompletedFirst Submitted
Initial submission to the registry
December 4, 2009
CompletedFirst Posted
Study publicly available on registry
December 7, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2010
CompletedMay 26, 2010
May 1, 2010
4 months
December 4, 2009
May 25, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To assess the safety and tolerability of AZD8418 following the oral administration of single ascending doses and to estimate the maximum tolerated dose in healthy volunteers.
Safety assessments will be obtained daily throughout the study
Secondary Outcomes (2)
To characterise the pharmacokinetics of AZD8418 and its metabolites in plasma and urine, and provisionally assess the dose proportionality of the pharmacokinetics following administration of single ascending doses of AZD8418.
samples will be obtained pre and post dose
To assess the effect of food on the safety and pharmacokinetic profile of AZD8418 and its metabolites.
samples will be obtained pre and post dose
Study Arms (2)
1
EXPERIMENTAL2
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Healthy male volunteers
- Healthy female volunteers of non-childbearing potential
You may not qualify if:
- History of any clinically significant medical, neurologic, or psychiatric disease (including repeated episodes of major depression) or a disorder which, in the opinion of the Investigator, may either put the volunteer at risk because of participation
- History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the Investigator, or history of hypersensitivity to drugs with a similar chemical structure or class to AZD8418
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (1)
Research Site
Overland Park, Kansas, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Philip T. Leese, M.D.
Quintiles, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
December 4, 2009
First Posted
December 7, 2009
Study Start
November 1, 2009
Primary Completion
March 1, 2010
Study Completion
March 1, 2010
Last Updated
May 26, 2010
Record last verified: 2010-05