AZD8529 Single Ascending Dose Study in Healthy Japanese Subjects

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00886756

Acronym

JSAD

Enrollment

Registered

2009-04-23

Start date

2009-04-30

Completion date

2009-07-31

Last updated

2009-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Phase I, Japanese healthy volunteer, AZD8529

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.

Interventions

DRUGAZD8529

Oral

DRUGPlacebo

Oral

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

MALE

Age

20 Years to 45 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
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.	From screening period to follow-up, 42 days (maiximum).

Secondary

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

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026