NCT00765492

Brief Summary

This is a study to evaluate safety, tolerability, PK and PD effects of orally administered AZD8529 after multiple ascending doses

Trial Health

100
On Track

Trial Health Score

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

Enrollment
47

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Oct 2008

Shorter than P25 for phase_1

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

October 1, 2008

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

October 2, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 3, 2008

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

June 26, 2009

Status Verified

June 1, 2009

First QC Date

October 2, 2008

Last Update Submit

June 25, 2009

Conditions

Healthy Volunteer

Keywords

Phase I

Outcome Measures

Primary Outcomes (1)

  • To assess the safety and tolerability of multiple dose administration of AZD8529 when given orally to healthy male subjects and female subjects of non-childbearing potential.

    each visit, at least daily, during the study.

Secondary Outcomes (1)

  • To characterize the pharmacokinetics of AZD8529 in plasma

    Blood samples will be taken during the study.

Study Arms (2)

1

EXPERIMENTAL
Drug: AZD8529

2

PLACEBO COMPARATOR
Drug: Placebo

Interventions

AZD8529DRUG

oral

1
PlaceboDRUG

oral

2

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Female subjects must be of non-child bearing potential.

You may not qualify if:

  • Has received another new chemical entity (defined as a compound which has not been approved for marketing) or has participated in any other clinical study that included drug treatment within 30months of the first administration of investigational prod
  • Plasma donation within one month of screening or any blood donation/blood loss \> 500mL during the 3 months prior to screening
  • Clinically relevant abnormalities in physical examinations, vital signs, ECG, clinical chemistry, hematology or urinalysis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

AZD8529

Study Officials

  • Mark Smith, MD, PhD

    AstraZeneca

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 2, 2008

First Posted

October 3, 2008

Study Start

October 1, 2008

Study Completion

March 1, 2009

Last Updated

June 26, 2009

Record last verified: 2009-06