- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00736658
AZD1386 Japanese Multiple Ascending Dosing Study (JMAD)
September 29, 2009 updated by: AstraZeneca
A Phase I, Randomised, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD1386 in Healthy Japanese Young and Elderly Subjects After Oral Multiple Doses.
This is a single centre, double-blind, randomised, parallel group, placebo controlled study to assess the safety, tolerability and pharmacokinetics of AZD1386 when given as multiple doses to 32 (24 healthy young and 8 healthy elderly) Japanese subjects.
For young healthy subjects (aged ≥20 to ≤45 inclusive) 3 consecutive multiple ascending dose panels are planned.
For elderly healthy subjects (aged ≥65 to≤80 inclusive) 1 multiple dose panel is planned.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
32
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
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Fukuoka, Japan
- Research Site
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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 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy Japanese males or females young (≥20 to ≤45 years inclusive) or elderly (≥65 to ≤80 years inclusive). Female subjects must be surgically sterile or post-menopausal.
- Body Mass Index (BMI) of ≥19 to ≤ 27 kg/m2 and weight of ≥45 to ≤90 kg
- Clinically normal physical findings including heart rate > 45 bpm and laboratory values and normal resting ECG
Exclusion Criteria:
- History of somatic or psychiatric disease/condition, which may interfere with the objectives of the study as judged by the investigator
- A family history of short or long QT syndrome (SQTS) or sudden cardiac death (SCD) amongst first degree relatives
- Subjects with orthostatic hypotension defined as a decrease of ≥ 25mmHg systolic blood pressure and/or a decrease of ≥15mmHg diastolic blood pressure within 5 minutes when going from a supine to standing position
- Clinically significant illness or clinically relevant trauma within 2 weeks prior to the administration of the investigational product as judged 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 Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: AZD1386
4 groups receiving a specified volume of the active component AZD1386 at different points of time.
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Oral admin. of doses at 11 days through a 12 days period.
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Placebo Comparator: Placebo
Included in each dose group
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Oral admin. of doses at 11 days through a 12 days period.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To investigate the safety and tolerability of AZD1386 after multiple dosing in young and elderly healthy Japanese subjects by assessment of adverse events, vital signs, ECG parameters, body temperature, clinical chemistry, haematology and urinalysis.
Time Frame: All assessments are made at each visit during the study.
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All assessments are made at each visit during the study.
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To determine the PK profile of AZD1386 after multiple dosing by assessment of plasma concentrations.
Time Frame: Blood samples will be taken before and after study drug administration.
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Blood samples will be taken before and after study drug administration.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Rolf Karlsten, Emerging Analgesia TA AstraZeneca R&D Södertälje, Sweden
- Principal Investigator: Shunji Matsuki, Kyusyu Clinical Phramacology Research 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
June 1, 2008
Study Completion (Actual)
September 1, 2008
Study Registration Dates
First Submitted
August 15, 2008
First Submitted That Met QC Criteria
August 15, 2008
First Posted (Estimate)
August 18, 2008
Study Record Updates
Last Update Posted (Estimate)
September 30, 2009
Last Update Submitted That Met QC Criteria
September 29, 2009
Last Verified
September 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- D5090C00012
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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