Phase I Multiple Ascending Dose Study for AZD 7268 in Healthy Volunteers
A Phase I, Single-center, Double-blind, Randomized, Placebo-controlled Study to Assess the Safety, Tolerability, and Pharmacokinetics of AZD7268 When Given in Multiple Ascending Oral Doses in Healthy Subjects
1 other identifier
interventional
40
1 country
1
Brief Summary
Multiple Ascending Dose Study
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 Apr 2009
Typical duration 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
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 12, 2009
CompletedFirst Posted
Study publicly available on registry
March 13, 2009
CompletedStudy Start
First participant enrolled
April 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2009
CompletedDecember 10, 2009
December 1, 2009
March 12, 2009
December 9, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To assess the safety and tolerability of AZD7268 when given orally in multiple ascending doses to healthy male subjects and female subjects of non-childbearing potential.
Safety assessments are made at each visit, at least daily, during the study.
Secondary Outcomes (1)
To characterize the pharmacokinetics of AZD7268 in plasma.
Serial blood samples for pharmacokinetic analysis will be collected on Days 1,2,3 and Days 9, 10, and 11 of the study. Additional pharmacokinetic samples will be collected on Days 6, 7, and 8
Study Arms (2)
AZD7268
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Provision of Informed Consent
- Healthy male subjects and female subjects (of non-child bearing potential)
- with suitable veins for cannulation or repeated venipuncture
You may not qualify if:
- Inability to understand or cooperate with given information
- Any positive result on screening for human immune deficiency virus (HIV), Hepatitis B, or Hepatitis C test
- History of seizure (including infancy febrile seizures) or family history of seizure
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (1)
Research Site
Philadelphia, Pennsylvania, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Sylvan Hurewitz, M.D.
AstraZeneca Clinical Pharmacology Unit, US
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 12, 2009
First Posted
March 13, 2009
Study Start
April 1, 2009
Study Completion
October 1, 2009
Last Updated
December 10, 2009
Record last verified: 2009-12