AZD1386 Japanese Multiple Ascending Dosing Study (JMAD)

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00736658
First received: August 15, 2008
Last updated: September 29, 2009
Last verified: September 2009
  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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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. ] [ Designated as safety issue: Yes ]

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. ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: August 15, 2008
Last Updated: September 29, 2009
Health Authority: United States: Food and Drug Administration
Japan: Pharmaceuticals and Medical Devices Agency

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

ClinicalTrials.gov processed this record on April 17, 2014