AZD1386 Japanese Multiple Ascending Dosing Study (JMAD)
Primary Purpose
Chronic Pain
Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
AZD1386
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Pain focused on measuring Japanese, MAD, Multiple ascending dose, Chronic pain
Eligibility Criteria
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
Sites / Locations
- Research Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
AZD1386
Placebo
Arm Description
4 groups receiving a specified volume of the active component AZD1386 at different points of time.
Included in each dose group
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
To determine the PK profile of AZD1386 after multiple dosing by assessment of plasma concentrations.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00736658
Brief Title
AZD1386 Japanese Multiple Ascending Dosing Study
Acronym
JMAD
Official Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
Keywords
Japanese, MAD, Multiple ascending dose, Chronic pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
32 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
AZD1386
Arm Type
Experimental
Arm Description
4 groups receiving a specified volume of the active component AZD1386 at different points of time.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Included in each dose group
Intervention Type
Drug
Intervention Name(s)
AZD1386
Intervention Description
Oral admin. of doses at 11 days through a 12 days period.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral admin. of doses at 11 days through a 12 days period.
Primary Outcome Measure Information:
Title
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.
Secondary Outcome Measure Information:
Title
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rolf Karlsten
Organizational Affiliation
Emerging Analgesia TA AstraZeneca R&D Södertälje, Sweden
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Shunji Matsuki
Organizational Affiliation
Kyusyu Clinical Phramacology Research Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
Fukuoka
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
AZD1386 Japanese Multiple Ascending Dosing Study
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