A Phase I, Single-Centre, Randomised, Double-Blind, Placebo Controlled Single-Ascending Dose, Study to Assess the Safety, Tolerability, Pharmacokinetics of AZD8529 in Healthy Male Japanese Subjects

AstraZeneca1 site in 1 country48 target enrollmentApril 2009

ConditionsHealthy

InterventionsAZD8529 Placebo

DrugsAZD8529 Placebo

Overview

Phase: Phase 1
Intervention: AZD8529
Conditions: Healthy
Sponsor: AstraZeneca
Enrollment: 48
Locations: 1
Primary Endpoint: To asses the safety:Adverse events, vital signs, physical examinations, telemetry, dECGs, clinical chemistry and haematology labs including testosterone, prolactin, LH, FSH and TSH, and urinalysis.
Status: Completed
Last Updated: 16 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a Phase I, double-blind, placebo-controlled, randomised within each dose group, single ascending dose study, with the objective to assess the safety, tolerability and pharmacokinetic profile of AZD8529 in healthy Japanese subjects.

Registry

clinicaltrials.gov

Start Date

April 2009

End Date

July 2009

Last Updated

16 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

AstraZeneca

Eligibility Criteria

Inclusion Criteria

•Healthy male Japanese subjects aged 20 to 45 years (inclusive)
•Have a body mass index (BMI) between 18 and 27 kg/m 2 (inclusive) and weigh at least 50 kg.least 50 kg.

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.
•Any clinically relevant abnormalities in physical examinations, vital signs, clinical chemistry, haematology or urinalysis as judged by the Investigator and/or Sponsor.
•Smoking in excess of 5 cigarettes per day or the equivalent within 28 days of Day 1.

Arms & Interventions

1

Intervention: AZD8529

2

Intervention: Placebo

Outcomes

Primary Outcomes

To asses the safety:Adverse events, vital signs, physical examinations, telemetry, dECGs, clinical chemistry and haematology labs including testosterone, prolactin, LH, FSH and TSH, and urinalysis.

Time Frame: From screening period to follow-up, 42 days (maiximum).

Secondary Outcomes

To characterize the pharmacokinetics of AZD8529 in plasma and urine.(Blood and urine sampling from pre-dose until 12 days post dose.)
To collect and store DNA for future exploratory research(One blood sampling after randomisation.)