AZD6765 Single and Multiple Ascending Dose Study in Healthy Male and Female Japanese and Caucasian Subjects
JSAD/JMAD
A Phase I, Single-center, Randomized, Double-blind, Placebo-controlled Single and Multiple Ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD6765 in Healthy Male and Female Japanese and Caucasian Subjects
1 other identifier
interventional
40
1 country
2
Brief Summary
This is a Phase I randomized double-blind, placebo-controlled, single and multiple ascending dose study to assess the safety, tolerability and pharmacokinetics of AZD6765 in healthy male and female Japanese and Caucasian 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 Nov 2008
2 active sites
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, 2008
CompletedFirst Submitted
Initial submission to the registry
November 3, 2008
CompletedFirst Posted
Study publicly available on registry
November 5, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2009
CompletedOctober 13, 2014
October 1, 2014
4 months
November 3, 2008
October 10, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety and tolerability; Adverse events (AEs), vital signs, physical examinations, ECGs and clinical laboratory assessments
During the study
Secondary Outcomes (2)
Pharmacokinetic - Pharmacokinetic parameters for AZD6765 in plasma and urine
During residential period
Genetics; Collect blood samples for optional exploratory genetic studies focusing on identification of genes that influence the disposition, efficacy, safety and tolerability of AZD6765.
During the study
Study Arms (2)
1
EXPERIMENTAL2
PLACEBO COMPARATORgiven (2 subjects in each ethnic/dose group)
Interventions
Eligibility Criteria
You may qualify if:
- Body mass index (BMI): 18 to 27 kg/m 2
- Female subjects must be postmenopausal for at least 1 year, surgically sterile, or using a reliable method of contraception at screening.
- Male subjects must be willing to use accepted contraceptive methods, avoid unprotected sex, and donating sperm until 3 months after drug administration.
You may not qualify if:
- Clinically relevant disease and/or abnormalities (past or present)
- Clinically relevant abnormalities in physical examinations,vital signs,clinical chemistry, hematology or urinalysis at screening as judged by the investigator
- Use of any prescription medication within 14 days of Day 1
- Use of over-the-counter (OTC) medication (with the exception of acetaminophen), vitamin/nutritional supplements and herbal preparations within 14 days of Day 1
- Smoking in excess of 5 cigarettes per day or the equivalent within 28 days of Day 1
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (2)
Research Site
Glendale, California, United States
Research Site
Baltimore, Maryland, United States
Related Links
MeSH Terms
Interventions
Study Officials
- PRINCIPAL INVESTIGATOR
Mark Yen, MD
California Clinical Trials
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 3, 2008
First Posted
November 5, 2008
Study Start
November 1, 2008
Primary Completion
March 1, 2009
Study Completion
March 1, 2009
Last Updated
October 13, 2014
Record last verified: 2014-10