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AZD1386 Japanese Multiple Ascending Dosing Study (JMAD)

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. Identifier: NCT00736658
Recruitment Status : Completed
First Posted : August 18, 2008
Last Update Posted : September 30, 2009
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Chronic Pain Drug: AZD1386 Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
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.
Study Start Date : June 2008
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. 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 :
  1. 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. ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

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 identifier (NCT number): NCT00736658

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Research Site
Fukuoka, Japan
Sponsors and Collaborators
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Study Director: Rolf Karlsten Emerging Analgesia TA AstraZeneca R&D Södertälje, Sweden
Principal Investigator: Shunji Matsuki Kyusyu Clinical Phramacology Research Clinic
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Responsible Party: Rolf Karlsten, MD, PhD, Medical Science Director Emerging Analgesia Clinical Neuroscience, AstraZeneca R&D Södertälje Identifier: NCT00736658    
Other Study ID Numbers: D5090C00012
First Posted: August 18, 2008    Key Record Dates
Last Update Posted: September 30, 2009
Last Verified: September 2009
Keywords provided by AstraZeneca:
Multiple ascending dose
Chronic pain
Additional relevant MeSH terms:
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Chronic Pain
Neurologic Manifestations