AZD8566 Food Effect/Microtracer Study

AstraZeneca21 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Healthy Volunteer Study

Interventions

AZD8566DRUG

Single 6 mg oral solution dose

AZD8566 IV carbon labelledDRUG

Single 10 mcg intravenous carbon-14 microtracer dose

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Research Site

Nottingham, United Kingdom

Outcomes

Primary Outcomes

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

Secondary Outcomes

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.

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

Intravenous pharmacokinetics

Time frame: Samples taken during visit 2, at up to 40 defined timepoints pre and post dose

Data from ClinicalTrials.gov

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