A Phase I, Single-center, Randomized, Double-blind, Placebo-controlled Single and Multiple Ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD6765 in Healthy Male and Female Japanese and Caucasian Subjects

AstraZeneca1 site in 1 country40 target enrollmentNovember 2008

ConditionsHealthy

InterventionsAZD6765 Placebo

DrugsAZD6765 Placebo

Overview

Phase: Phase 1
Intervention: AZD6765
Conditions: Healthy
Sponsor: AstraZeneca
Enrollment: 40
Locations: 1
Primary Endpoint: Safety and tolerability; Adverse events (AEs), vital signs, physical examinations, ECGs and clinical laboratory assessments
Status: Completed
Last Updated: 11 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 AZD6765 in healthy male and female Japanese and Caucasian subjects

Registry

clinicaltrials.gov

Start Date

November 2008

End Date

March 2009

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

AstraZeneca

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Body mass index (BMI): 18 to 27 kg/m 2
•Female subjects must be postmenopausal for at least 1 year, surgically sterile, or using a reliable method of contraception at screening.
•Male subjects must be willing to use accepted contraceptive methods, avoid unprotected sex, and donating sperm until 3 months after drug administration.

Exclusion Criteria

•Clinically relevant disease and/or abnormalities (past or present)
•Clinically relevant abnormalities in physical examinations,vital signs,clinical chemistry, hematology or urinalysis at screening as judged by the investigator
•Use of any prescription medication within 14 days of Day 1
•Use of over-the-counter (OTC) medication (with the exception of acetaminophen), vitamin/nutritional supplements and herbal preparations within 14 days of Day 1
•Smoking in excess of 5 cigarettes per day or the equivalent within 28 days of Day 1

Arms & Interventions

1

Intervention: AZD6765

2

given (2 subjects in each ethnic/dose group)

Intervention: Placebo

Outcomes

Primary Outcomes

Safety and tolerability; Adverse events (AEs), vital signs, physical examinations, ECGs and clinical laboratory assessments

Time Frame: During the study

Secondary Outcomes

Pharmacokinetic - Pharmacokinetic parameters for AZD6765 in plasma and urine(During residential period)
Genetics; Collect blood samples for optional exploratory genetic studies focusing on identification of genes that influence the disposition, efficacy, safety and tolerability of AZD6765.(During the study)