AZD8566 Food Effect/Microtracer Study

Healthy Volunteer Study Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00866385
• Other study ID #: D1320C00011
• Secondary ID: Pharmaceutical P
• Status: Completed
• Phase: Phase 1
• First received: March 19, 2009
• Last updated: June 8, 2009
• Start date: March 2009
• Est. completion date: April 2009

Study information

• Verified date: June 2009
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: April 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy Volunteer Study

Intervention

Drug:
• AZD8566
Single 6 mg oral solution dose
• AZD8566 IV carbon labelled
Single 10 mcg intravenous carbon-14 microtracer dose

Locations

Country	Name	City	State
United Kingdom	Research Site	Nottingham

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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.	Yes
Secondary	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	No
Secondary	Intravenous pharmacokinetics		Samples taken during visit 2, at up to 40 defined timepoints pre and post dose	No