NCT00755378

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
58

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Sep 2008

Shorter than P25 for phase_1

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

September 18, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 19, 2008

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

March 26, 2009

Status Verified

March 1, 2009

First QC Date

September 18, 2008

Last Update Submit

March 25, 2009

Conditions

Healthy Volunteer

Keywords

Phase I

Outcome Measures

Primary Outcomes (1)

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

    at each visit, at least daily, during the study.

Secondary Outcomes (2)

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

    Blood and urine samples will be taken during the study.

  • To asses the effect of food on the safety and pharmacokinetic profile of AZD8529.

    Safety assessments and blood and urine samples will be taken throughout 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:

  • Healthy male or female subjects aged 18 to 45 years (inclusive) on Day 1. 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 3 months 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

Study Sites (1)

Research Site

Philadelphia, Pennsylvania, United States

Location

MeSH Terms

Interventions

AZD8529

Study Officials

  • Sylvan J Hurewitz, MD

    AstraZeneca Clinical Pharmacology Unit, US

    PRINCIPAL INVESTIGATOR

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

September 18, 2008

First Posted

September 19, 2008

Study Start

September 1, 2008

Study Completion

March 1, 2009

Last Updated

March 26, 2009

Record last verified: 2009-03

Locations

US(1)