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CompletedNCT00886756JSADUpdated Aug 19, 2009

AZD8529 Single Ascending Dose Study in Healthy Japanese Subjects

A Phase 1 interventional study of AZD8529 and Placebo in Healthy, sponsored by AstraZeneca. Completed at 1 site in United Kingdom. Open to male participants aged 20 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2009-08-19.

Sponsored by AstraZeneca · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
20 Years to 45 Years
Sex
Male
01

Study 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.

02

Conditions studied

  • Healthy

Keywords

  • Phase I
  • Japanese healthy volunteer
  • AZD8529
03

In context

Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 45 Years
Sexes eligible
Male
Accepts 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

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.
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
48 participants (estimated)

Study arms

  • Experimental
    1

    Drug: AZD8529

  • Placebo comparator
    2

    Drug: Placebo

Interventions

  • DrugAZD8529

    Oral

  • DrugPlacebo

    Oral

06

What researchers measure

Primary outcomes

  1. 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

  1. To characterize the pharmacokinetics of AZD8529 in plasma and urine.

    Time frame: Blood and urine sampling from pre-dose until 12 days post dose.

  2. To collect and store DNA for future exploratory research

    Time frame: One blood sampling after randomisation.

07

Study locations

1 site
  • Research Site
    London, United Kingdom
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 19, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00886756
Lead sponsor
AstraZeneca
First posted
Apr 23, 2009
Start date
Apr 2009
Completion
Jul 2009
Last update
Aug 19, 2009

Study contacts

Ulrike Lorch, MD MFPM FRCA
principal investigator · Richmond Pharmacology Limited

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2009. You cannot join it, but the record below documents what was studied.

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