Study to Investigate Safety, Tolerability and Pharmacokinetics of AZD2423 in Healthy Volunteers
SAD
A Phase I, Single Centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability and Pharmacokinetics of Oral AZD2423 After Single Ascending Doses in Healthy Male and Female Volunteers Without Childbearing Potential
2 other identifiers
interventional
80
1 country
1
Brief Summary
The primary aim of this study is to investigate the safety and tolerability of AZD2423 single doses in healthy volunteers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 healthy-volunteers
Started Jul 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
July 1, 2009
CompletedFirst Submitted
Initial submission to the registry
July 14, 2009
CompletedFirst Posted
Study publicly available on registry
July 15, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2009
CompletedDecember 10, 2010
December 1, 2010
4 months
July 14, 2009
December 8, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To assess the safety and tolerability of AZD2423 following administration of single ascending doses and if possible to estimate the maximum tolerated dose (MTD), if within the predefined exposure limits.
3 day residential period plus 7-10 days follow up
Secondary Outcomes (1)
To characterise the pharmacokinetics of AZD2423 and provisionally assess the dose proportionality of the pharmacokinetics following administration of single ascending doses ofAZD2423.
3 day residential period plus 7-10 days follow up
Study Arms (2)
A
EXPERIMENTALAZD2423
B
EXPERIMENTALPlacebo
Interventions
Eligibility Criteria
You may qualify if:
- Provision of signed and dated, written informed consent prior to any study specific procedures
- Have a body mass index (BMI) between ≥18 and ≤30 kg/m2, as calculated by the investigator, and weigh at least 50 kg and no more than 100 kg
- Healthy male and non-fertile female volunteers with suitable veins for cannulation or repeated venipuncture
You may not qualify if:
- History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study,or influence the results or the subject's ability to participate in the study
- History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs
- Any clinically significant illness/infection or medical/surgical procedure or trauma,as judged by the Principal Investigator, within 3 months of the first administration of investigational product
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (1)
Research Site
Berlin, Germany
Study Officials
- PRINCIPAL INVESTIGATOR
Rainard Fuhr, MD
PAREXEL Early Phase Clinical Uniit, Berlin Germany
- STUDY DIRECTOR
Anders Neijber
AstraZeneca R&D Södertälje
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
July 14, 2009
First Posted
July 15, 2009
Study Start
July 1, 2009
Primary Completion
November 1, 2009
Study Completion
November 1, 2009
Last Updated
December 10, 2010
Record last verified: 2010-12