AZD1386 Japanese Multiple Ascending Dosing Study

NCT00736658 | Completed Phase 1

• 1 other identifier: D5090C00012
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain

Keywords

Japanese; MAD; Multiple ascending dose; Chronic pain

Outcome Measures

Primary Outcomes (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.

  All assessments are made at each visit during the study.

Secondary Outcomes (1)

• To determine the PK profile of AZD1386 after multiple dosing by assessment of plasma concentrations.

  Blood samples will be taken before and after study drug administration.

Study Arms (2)

AZD1386

EXPERIMENTAL

4 groups receiving a specified volume of the active component AZD1386 at different points of time.

Drug: AZD1386

Placebo

PLACEBO COMPARATOR

Included in each dose group

Drug: Placebo

Interventions

AZD1386 DRUG

Oral admin. of doses at 11 days through a 12 days period.

AZD1386

Placebo DRUG

Oral admin. of doses at 11 days through a 12 days period.

Placebo

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Fukuoka, Japan

Location

MeSH Terms

Conditions

Chronic Pain

Interventions

AZD1386

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Rolf Karlsten

  Emerging Analgesia TA AstraZeneca R&D Södertälje, Sweden

  STUDY DIRECTOR

• Shunji Matsuki

  Kyusyu Clinical Phramacology Research Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 15, 2008
• First Posted: August 18, 2008
• Study Start: June 1, 2008
• Study Completion: September 1, 2008
• Last Updated: September 30, 2009

Record last verified: 2009-09

Locations

JP (1)