To Evaluate the Effect of Food on the Pharmacokinetics (PK) of AZD0328

Healthy Clinical Trial

Official title:

A Phase I, Open, Randomized, Single-Dose, Two-Treatment (Fed Versus Fasting), Two-Period Cross-Over Single-Centre Study to Evaluate the Effect of Food on the Pharmacokinetics of AZD0328 Following Oral Administration (Capsule) in Healthy Male Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00752830
• Other study ID #: D0190C00009
• Secondary ID: EUdract NO 2008-
• Status: Completed
• Phase: Phase 1
• First received: September 12, 2008
• Last updated: October 28, 2008
• Start date: September 2008
• Est. completion date: October 2008

Study information

• Verified date: October 2008
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products AgencySweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 45 Years

Eligibility

Inclusion Criteria:

• Healthy male Caucasian subjects.

• Clinically normal physical findings, laboratory values, vital signs and resting ECG as judged by the investigator.

• Signed informed consent form

Exclusion Criteria:

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• AZD0328
Oral capsule, single dose

Locations

Country	Name	City	State
Sweden	Research Site	Lund

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PK variables		Several PK samples during the study days	No
Secondary	Safety variables (adverse events, blood pressure, laboratory measurements and paper ECGs)		During the whole treatment period	Yes