AZD8566 Food Effect/Microtracer Study - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00866385

Purpose

A study designed to look at how the drug AZD8566 is taken up by the body when given with or without food. In some subjects a comparison will be made with a very small labelled microdose given into a vein.

Condition	Intervention	Phase
Healthy Volunteer Study	Drug: AZD8566 Drug: AZD8566 IV carbon labelled	Phase I

Study Type:	Interventional
Study Design:	Basic Science, Randomized, Open Label, Crossover Assignment, Pharmacokinetics Study
Official Title:	An Open, Randomised, Phase I, 2-Period Crossover Trial to Investigate the Absolute Bioavailability and the Effect of Food on the Oral Bioavailability of AZD8566 in Healthy Volunteers

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Pharmacokinetic profile: concentration of AZD8566 in blood in the presence or absence of food [ Time Frame: Samples taken during visit 2 and visit 3, at up to 16 defined timepoints pre and post dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety and tolerability of AZD8566 in healthy volunteers in the fed and fasted state by assessment of vital signs, laboratory variables, ECGs and adverse events [ Time Frame: Assessments taken during visit 1 and at defined timepoints pre and post dose during visits 2 and 3. Volunteers will be monitored throughout the study for adverse events. ] [ Designated as safety issue: Yes ]
Bioavailability of an oral solution formulation of AZD8566 in the fasted state compared with an intravenous carbon-14 microtracer dose [ Time Frame: Samples taken during visit 2, at up to 40 defined timepoints pre and post dose ] [ Designated as safety issue: No ]
Intravenous pharmacokinetics [ Time Frame: Samples taken during visit 2, at up to 40 defined timepoints pre and post dose ] [ Designated as safety issue: No ]

Enrollment:	21
Study Start Date:	March 2009
Study Completion Date:	April 2009
Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Intervention Details:

Single 6 mg oral solution dose

Single 10 mcg intravenous carbon-14 microtracer dose

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Provision of written informed consent
Clinically normal physical findings and laboratory values as judged by the investigator with normal ECG
Females who are permanently or surgically sterile or post-menopausal and males

Exclusion Criteria:

History of any convulsions or seizures
History of infection or risk of infection due to recent surgery or trauma
History or presence of conditions know to interfere with the absorption, distribution, metabolism and excretion of the study drug

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00866385

Locations

United Kingdom
Research Site
Nottingham, United Kingdom

Sponsors and Collaborators

AstraZeneca

Investigators

Principal Investigator:

Jo Collier, Dr ,MB, ChB

Pharmaceutical Profiles, Mere Way, Ruddington Fields, Nottingham NG11 6JS

More Information

No publications provided

Responsible Party:	AstraZeneca ( H Parmar MD, (Acting) Medical Science Director, Respiratory and )
Study ID Numbers:	D1320C00011, Pharmaceutical Profiles PL1168
Study First Received:	March 19, 2009
Last Updated:	June 8, 2009
ClinicalTrials.gov Identifier:	NCT00866385 History of Changes
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency; United Kingdom: Research Ethics Committee

Keywords provided by AstraZeneca:

Healthy Volunteer
AZD8566
Food Effect
Microtracer

Study placed in the following topic categories:

Healthy

ClinicalTrials.gov processed this record on August 25, 2009