NCT00752830

Brief Summary

The purpose of the study is to evaluate the effect of food on the pharmacokinetics of AZD0328 in healthy male volunteers. AZD0328 will be administered as a single oral dose (capsule) during two treatment periods, after food intake or during fasting condition.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Sep 2008

Shorter than P25 for phase_1 healthy

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
11 days until next milestone

First Submitted

Initial submission to the registry

September 12, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 15, 2008

Completed
16 days 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

1 month

First QC Date

September 12, 2008

Last Update Submit

October 28, 2008

Conditions

Healthy

Keywords

AZD0328Food Effect

Outcome Measures

Primary Outcomes (1)

  • PK variables

    Several PK samples during the study days

Secondary Outcomes (1)

  • Safety variables (adverse events, blood pressure, laboratory measurements and paper ECGs)

    During the whole treatment period

Study Arms (2)

1

EXPERIMENTAL

AZD0328 administration during fasting condition

Drug: AZD0328

2

EXPERIMENTAL

AZD0328 administration after food intake

Drug: AZD0328

Interventions

AZD0328DRUG

Oral capsule, single dose

12

Eligibility Criteria

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

You may qualify if:

  • Healthy male Caucasian subjects.
  • Clinically normal physical findings, laboratory values, vital signs and resting ECG as judged by the investigator.
  • Signed informed consent form

You may not qualify if:

  • History of clinically significant cardio or cerebrovascular, pulmonary, renal, hepatic, neurological, mental or gastrointestinal disorder (including dyspepsia or GERD) or any other major disorder that may interfere with the study.
  • Intake of another investigational drug or participation in another study which may interfere with the objectives of the study, within 12 weeks before the administration of the investigational product.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Lund, Sweden

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

  • Gabriella Samuelsson Palmgren, MD

    AstraZeneca Clinical Pharmacology Unit, AstraZeneca R&D Lund,Sweden

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 12, 2008

First Posted

September 15, 2008

Study Start

September 1, 2008

Primary Completion

October 1, 2008

Study Completion

October 1, 2008

Last Updated

October 29, 2008

Record last verified: 2008-10

Locations

SE(1)