NCT00886756

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Apr 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

April 21, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 23, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

August 19, 2009

Status Verified

August 1, 2009

First QC Date

April 21, 2009

Last Update Submit

August 18, 2009

Conditions

Healthy

Keywords

Phase IJapanese healthy volunteerAZD8529

Outcome Measures

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.

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

Secondary Outcomes (2)

  • 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.

Study Arms (2)

1

EXPERIMENTAL
Drug: AZD8529

2

PLACEBO COMPARATOR
Drug: Placebo

Interventions

AZD8529DRUG

Oral

1
PlaceboDRUG

Oral

2

Eligibility Criteria

Age20 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

London, United Kingdom

Location

MeSH Terms

Interventions

AZD8529

Study Officials

  • Ulrike Lorch, MD MFPM FRCA

    Richmond Pharmacology Limited

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 21, 2009

First Posted

April 23, 2009

Study Start

April 1, 2009

Study Completion

July 1, 2009

Last Updated

August 19, 2009

Record last verified: 2009-08

Locations

GB(1)