AZD7325 Multiple Ascending Dose Study
MAD
A Phase I, Single-Center, Randomized, Double-Blind, Placebo-Controlled, Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD7325 When Given in Multiple Ascending Oral Doses in Healthy Male and Healthy Female Subjects of Non-child Bearing Potential
1 other identifier
interventional
48
1 country
1
Brief Summary
This is a study to evaluate safety, tolerability, PK and PD effects of orally administered AZD7325 after single and repeated ascending doses.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Mar 2008
Shorter than P25 for phase_1
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
Study Start
First participant enrolled
March 1, 2008
CompletedFirst Submitted
Initial submission to the registry
May 19, 2008
CompletedFirst Posted
Study publicly available on registry
May 21, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2008
CompletedDecember 9, 2010
December 1, 2010
4 months
May 19, 2008
December 7, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To assess the safety and tolerability of multiple ascending oral doses of AZD7325 compared to placebo by assessment of adverse events, vital signs, physical examinations, laboratory parameters, and ECGs
Alssessments are made at each visit, at least daily, during the study.
Secondary Outcomes (3)
Evaluation and characterization of the pharmacokinetics of AZD7325 when given orally in multiple ascending doses
Blood samples will be taken during the study.
Evaluation of the pharmacodynamic effects of AZD7325
Test batteries will be performed at specified times both before and following study drug administration.
Identification of genes that influence the disposition, efficacy, safety and tolerability of AZD7325.
A single blood sample will be obtained.
Study Arms (1)
1
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Female subjects must be of non-child bearing potential.
You may not qualify if:
- Clinically significant illness within 2 weeks before the study start.
- Enrollment in another concurrent investigational study or intake of an investigational drug within 30 days or intake of an investigational drug within a period of 5 half lives of that drug prior to the screening visit
- Blood loss in excess of 200 mL within 30 days of Day -2, in excess of 400 mL within 90 days of Day -2, or in excess of 1200 mL within 1 year of Day -2
- Clinically relevant abnormalities in physical examinations, vital signs, ECG, clinical chemistry, hematology or urinalysis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (1)
Research Site
Philadelphia, Pennsylvania, United States
MeSH Terms
Interventions
Study Officials
- PRINCIPAL INVESTIGATOR
Sylvan J. Hurewitz, MD
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
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 19, 2008
First Posted
May 21, 2008
Study Start
March 1, 2008
Primary Completion
July 1, 2008
Study Completion
July 1, 2008
Last Updated
December 9, 2010
Record last verified: 2010-12