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AZD1305 Single and Multiple Ascending Dose Study in Healthy Japanese and Caucasian Subjects

NCT00935025 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2010-12-07

No results posted yet for this study

Summary

This is a phase I, single-blind, randomized, placebo-controlled single and repeated ascending dose study to assess the safety, tolerability and pharmacokinetics with oral doses of AZD1305 extended-release capsules in healthy male Japanese and Caucasian subjects. Three (or four if needed) dose levels will be given to Japanese subjects and one of the doses will also be given to Caucasian subjects.

Conditions

  • Healthy

Interventions

DRUG

AZD1305

single and multiple oral doses, extended-release capsule

DRUG

Placebo

single and multiple oral doses, capsule

Sponsors & Collaborators

Principal Investigators

  • Mark Yen, M.D. · California Clinical Trials

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2009-11-30
Completion
2009-11-30

Countries

  • United States

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 NCT00935025 on ClinicalTrials.gov