- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00818129
Study to Investigate Safety, Tolerability and PK Following Single and Multiple Ascending Doses of AZD7295 in Japanese
July 22, 2009 updated by: AstraZeneca
A Phase I, Randomized, Double-Blind, Placebo-controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD7295 Following Single and Multiple Ascending Oral Dose Administration in Healthy Male Japanese Subjects
The primary objective of this study is to investigate the safety and tolerability of single and multiple oral doses of AZD7295 in healthy male Japanese subjects.
This will be done by comparing the effect of AZD7295 to placebo.
The study will aslo investigate the absorption, distribution and disappearance of AZD7295 in the body.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
62
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Fukuoka
-
Fukuoka-City, Fukuoka, Japan
- Research Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 55 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Provision of signed, written and dated informed consent
- Healthy male Japanese volunteers aged 20-55 years
- BMI between 18 and 27 kg/m2
- Have negative screens for HIV, hepatitis B and C viruses and syphilis
Exclusion Criteria:
- Use of prescribed medication within 2 weeks prior to the dose of study medication
- Participation in another study that included drug treatment within 16 weeks before the start of the present study.
- History or presence of gastrointestinal, hepatic or renal disease or a condition known to interfere with absorption, distribution, metabolism or excretion of drugs.
- History of severe food or drug allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged relevant by the investigator.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
PLACEBO_COMPARATOR: 2
|
multiple ascending dose (tbd based on single dose results), oral solution
|
EXPERIMENTAL: 1
|
ascending single doses (start dose 90 mg), oral solution and then multiple ascending dose (tbd based on single dose results), oral solution
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
AE, safety laboratory test (haematology, clinical chemistry, urinalysis), 12-lead ECG, BP, pulse rate, body temperature
Time Frame: During the study
|
During the study
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pharmacokinetics (Cmax, tmax, AUC, AUC0-t, CL/F, Vss/F, t1/2 , Cmin, Rac, etc)
Time Frame: Frequent sampling until 72 hours after single administration in Single Dose Part and until 72 hours after last administration (6 days administration) in Multiple Dose Part
|
Frequent sampling until 72 hours after single administration in Single Dose Part and until 72 hours after last administration (6 days administration) in Multiple Dose Part
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Masatoshi Tsukamoto, MD, Kyushu Clinical Pharmacolgy Reasearch Clinic
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2008
Study Completion (ACTUAL)
May 1, 2009
Study Registration Dates
First Submitted
December 24, 2008
First Submitted That Met QC Criteria
January 6, 2009
First Posted (ESTIMATE)
January 7, 2009
Study Record Updates
Last Update Posted (ESTIMATE)
July 23, 2009
Last Update Submitted That Met QC Criteria
July 22, 2009
Last Verified
July 1, 2009
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- D1820C00001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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