AZD1386 Japanese Multiple Ascending Dosing Study - Full Text View

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:

MedlinePlus related topics: Chronic Pain

U.S. FDA Resources

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 May 19, 2013

AZD1386 Japanese Multiple Ascending Dosing Study (JMAD)