AZD8566 Food Effect/Microtracer Study

• Sponsor: AstraZeneca (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00866385
• Collaborator: (none)
• Enrollment: 21
• Location: 1
• Duration (Months): 1
• Patients Per Site Per Month: 20.6

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Healthy Volunteer Study	Drug: AZD8566; Drug: AZD8566 IV carbon labelled	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 21 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• 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
• Study Start Date: Mar 1, 2009
• Actual Primary Completion Date: Mar 1, 2009
• Actual Study Completion Date: Apr 1, 2009

Outcome Measures

Primary Outcome Measures

1. Pharmacokinetic profile: concentration of AZD8566 in blood in the presence or absence of food [Samples taken during visit 2 and visit 3, at up to 16 defined timepoints pre and post dose]

Secondary Outcome Measures

1. 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 [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.]

2. Bioavailability of an oral solution formulation of AZD8566 in the fasted state compared with an intravenous carbon-14 microtracer dose [Samples taken during visit 2, at up to 40 defined timepoints pre and post dose]

3. Intravenous pharmacokinetics [Samples taken during visit 2, at up to 40 defined timepoints pre and post dose]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00866385
• Other Study ID Numbers: D1320C00011; Pharmaceutical Profiles PL1168
• First Posted: Mar 20, 2009
• Last Update Posted: Jun 9, 2009
• Last Verified: Jun 1, 2009

• Keywords provided by , ,: Healthy Volunteer; AZD8566; Food Effect; Microtracer

Study Results

No Results Posted as of Jun 9, 2009