A Phase I, Single Center, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of Intravenous AZD9742 in Healthy Male and Female Japanese Subjects

AstraZeneca1 site in 1 country35 target enrollmentApril 2010

ConditionsHealthy

InterventionsAZD9742 Placebo

DrugsAZD9742 Placebo

Overview

Phase: Phase 1
Intervention: AZD9742
Conditions: Healthy
Sponsor: AstraZeneca
Enrollment: 35
Locations: 1
Primary Endpoint: Safety variables (adverse events, vital signs, physical examinations, clinical laboratory assessments, 12-lead ECG, digital ECG, telemetry)
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a Phase I randomized double-blind, placebo-controlled, single and multiple ascending dose study to assess the safety, tolerability and pharmacokinetics of AZD9742 in healthy male and female Japanese subjects

Registry

clinicaltrials.gov

Start Date

April 2010

End Date

July 2010

Last Updated

15 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

AstraZeneca

Eligibility Criteria

Inclusion Criteria

•female (non-childbearing potential)
•Body mass index (BMI) : 17 to 27 kg/m 2

Exclusion Criteria

•History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study
•History or presence of gastrointestinal, hepatic, or renal disease or any otherHistory or presence of gastrointestinal, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs
•Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of investigational product