NCT00738959

Brief Summary

This study will be performed to evaluate the safety, tolerability and pharmacokinetics of single and multiple doses of AZD0328 when administered to Japanese and Caucasian healthy male volunteers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P75+ for phase_1 healthy-volunteers

Timeline
Completed

Started Jun 2008

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

June 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 20, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 21, 2008

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
Last Updated

October 29, 2008

Status Verified

October 1, 2008

Enrollment Period

4 months

First QC Date

August 20, 2008

Last Update Submit

October 28, 2008

Conditions

Healthy Volunteers

Keywords

AZD0328JapaneseCaucasianpharmacokineticssafetytolerability

Outcome Measures

Primary Outcomes (1)

  • Safety variables (adverse events, vital signs, paper ECGs and 12-lead continuous digital ECGs including QT/QTc interval measurements

    During the whole treatment period

Secondary Outcomes (1)

  • PK variables

    Several samples during the study days

Study Arms (1)

1

EXPERIMENTAL
Drug: AZD0328

Interventions

AZD0328DRUG

Oral solution A single dose Day 1 followed by once daily doses on Day 3-7

1

Eligibility Criteria

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

You may qualify if:

  • first generation Japanese (both parents and grandparents are Japanese, the subject is born in Japan and left Japan less than 10 years ago) or Caucasian subjects.
  • Clinically normal physical findings, laboratory values, vital signs and resting ECG as judged by the investigator.

You may not qualify if:

  • History of clinically significant cardio- or cerebrovascular, pulmonary, renal, hepatic, neurological, mental or gastrointestinal disorder or any other major disorder that may interfere with the study.
  • Participation in another study within 12 weeks before the first administration of the investigational product.
  • Intake of any prescribed medicine or herbal remedies based on St John's Wort, except for occasional paracetamol and nasal adrenergic anticongestants, within 3 weeks before the first administration of the investigational product.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

London, United Kingdom

Location

MeSH Terms

Interventions

spiro(1-azabicyclo(2.2.2)octane-3,2'(3H)-furo(2,3-b)pyridine)

Study Officials

  • Didier Meulien, MD

    AstraZeneca R&D Södertälje, Sweden

    STUDY DIRECTOR

  • Ulrike Lorch, MD

    Richmond Pharmacology Ltd St George's University of London Cranmer Terrace, TootingLondon SW17 ORE UK

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 20, 2008

First Posted

August 21, 2008

Study Start

June 1, 2008

Primary Completion

October 1, 2008

Study Completion

October 1, 2008

Last Updated

October 29, 2008

Record last verified: 2008-10

Locations

GB(1)