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Study to Assess the Safety, Tolerability and Pharmacokinetics After Multiple Doses of AZD2066 in Japanese Subjects

NCT00766012 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 132

Last updated 2009-08-25

No results posted yet for this study

Summary

The purpose of this study is to investigate the safety, tolerability and pharmacokinetics of AZD2066 when given as multiple doses to Japanese healthy male subjects. Four (4) consecutive multiple-ascending panels are planned. Subjects will start with an initial single dose that is followed by a wash-out period of 48 hours to adequately define the single-dose pharmacokinetics. For the third and forth dose panels, the wash-out period will be extended to be 96 hours to evaluate the safety of subjects. Thereafter the subjects will be dosed once daily for 10 days. Ten (10) subjects will be allocated to each dose panel and randomized to receive either AZD2066 or placebo.

Conditions

  • Healthy

Interventions

DRUG

AZD2066

Oral solution administered orally once per day on day 1, and then day 3 through to day 12 for the first and second dose panels and day 5 through to day 14 for the third and fourth dose panels. For the fifth and sixth panels, oral solution administered once per day on day 1, and then day 5 through to day 16. Specific dose depends on dose panel.

DRUG

Placebo

Oral solution administered orally once per day on day 1, and then day 3 through to day 12 for the first and second dose panels and day 5 through to day 14 for the third and fourth dose panels. For the fifth and sixth panels, oral solution administered once per day on day 1, and then day 5 through to day 16.

Sponsors & Collaborators

Principal Investigators

  • Anders Neijber · AstraZeneca R&D Södertälje, Sweden

  • Shin Irie · Kyusyu Clinical Phramacology Research Clinic

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-09-30
Completion
2009-07-31

Countries

  • Japan

Study Locations

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Entities

Drugs
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 NCT00766012 on ClinicalTrials.gov