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AZD1386 Japanese Multiple Ascending Dosing Study (JMAD)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00736658
First Posted: August 18, 2008
Last Update Posted: September 30, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
AstraZeneca
  Purpose
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.

Condition Intervention Phase
Chronic Pain Drug: AZD1386 Drug: Placebo Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

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. [ Time Frame: All assessments are made at each visit during the study. ]

Secondary Outcome Measures:
  • 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. ]

Estimated Enrollment: 32
Study Start Date: June 2008
Study Completion Date: September 2008
Arms Assigned Interventions
Experimental: AZD1386
4 groups receiving a specified volume of the active component AZD1386 at different points of time.
Drug: AZD1386
Oral admin. of doses at 11 days through a 12 days period.
Placebo Comparator: Placebo
Included in each dose group
Drug: Placebo
Oral admin. of doses at 11 days through a 12 days period.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00736658


Locations
Japan
Research Site
Fukuoka, Japan
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Rolf Karlsten Emerging Analgesia TA AstraZeneca R&D Södertälje, Sweden
Principal Investigator: Shunji Matsuki Kyusyu Clinical Phramacology Research Clinic
  More Information

Responsible Party: Rolf Karlsten, MD, PhD, Medical Science Director Emerging Analgesia Clinical Neuroscience, AstraZeneca R&D Södertälje
ClinicalTrials.gov Identifier: NCT00736658     History of Changes
Other Study ID Numbers: D5090C00012
First Submitted: August 15, 2008
First Posted: August 18, 2008
Last Update Posted: September 30, 2009
Last Verified: September 2009

Keywords provided by AstraZeneca:
Japanese
MAD
Multiple ascending dose
Chronic pain

Additional relevant MeSH terms:
Chronic Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms