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AZD1386 Japanese Multiple Ascending Dosing Study

NCT00736658 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2009-09-30

No results posted yet for this study

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

Interventions

DRUG

AZD1386

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

DRUG

Placebo

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

Sponsors & Collaborators

Principal Investigators

  • Rolf Karlsten · Emerging Analgesia TA AstraZeneca R&D Södertälje, Sweden

  • Shunji Matsuki · Kyusyu Clinical Phramacology Research Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-06-30
Completion
2008-09-30

Countries

  • Japan

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00736658 on ClinicalTrials.gov