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AZD8566

Phase 1

Healthy Volunteer | Small molecule | Other |AstraZeneca PLC|Last Updated: Jun 9, 2009

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment108

FDA Designations

No designations recorded

Clinical trial landscape

AZD8566 · 3 trials · 3 indications

Phase 1 3
NCT00866385AZD8566 Food Effect/Microtracer StudyHealthy Volunteer Study
COMPLETED21 Analytics
NCT00844103Study to Investigate the Safety, Tolerability and Pharmacokinetics of Multiple Doses of AZD8566.Pharmacokinetics
COMPLETED36 Analytics
NCT00749333Study to Investigate the Safety, Tolerability and Pharmacokinetics of Single Doses of AZD8566.Healthy Volunteer
COMPLETED108 Analytics
PHASE1COMPLETED
AZD8566 Food Effect/Microtracer Study
Healthy Volunteer StudyUnlock trial analytics
PHASE1COMPLETED
Study to Investigate the Safety, Tolerability and Pharmacokinetics of Multiple Doses of AZD8566.
PharmacokineticsUnlock trial analytics
PHASE1COMPLETED
Study to Investigate the Safety, Tolerability and Pharmacokinetics of Single Doses of AZD8566.
Healthy VolunteerUnlock trial analytics

Study Endpoints

Primary Endpoints

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
Pharmacokinetic profile: concentration of AZD8566 in blood
Samples taken during Visit 2 (residential period) at up to 15 defined timepoints pre-dose and post- dose on Day 1 and Day 10
Safety and tolerability of AZD8566 by assessment of vital signs, laboratory variables, ECG and adverse events
Assessments taken at Visit 1 (enrolment), defined timepoints pre-dose and post-dose during Visit 2 (residential period) and at Visit 3 (follow up). Volunteers will be monitored throughout the study from Visit 1 to Visit 3 for adverse events.

Secondary Endpoints

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.
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
Intravenous pharmacokinetics
Samples taken during visit 2, at up to 40 defined timepoints pre and post dose
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
1EXPERIMENTAL -
2PLACEBO_COMPARATOR -

Interventions

NameTypeDescription
AZD8566DRUGSingle 6 mg oral solution dose
AZD8566 IV carbon labelledDRUGSingle 10 mcg intravenous carbon-14 microtracer dose
PlaceboDRUG10ml oral solution administered once a day over 10 days.
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

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 o...

Countries:United Kingdom
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Frequently asked questions about AZD8566

What is AZD8566?

AZD8566 is an investigational small molecule being developed by AstraZeneca PLC (AZN). It has been studied in healthy volunteers in Phase 1 clinical trials to evaluate its safety, tolerability, and pharmacokinetics. The drug is not approved and remains in clinical development.

What is AZD8566 used for?

AZD8566 has been studied in healthy volunteer studies to assess its safety, tolerability, and pharmacokinetics. It has not been evaluated in any patient population or for any specific disease indication in the available clinical trials.

Who makes AZD8566?

AZD8566 is being developed by AstraZeneca PLC, a multinational pharmaceutical company listed on the stock exchange under the ticker symbol AZN. AstraZeneca sponsored the Phase 1 clinical trials of AZD8566.

What phase is AZD8566 in?

AZD8566 is in Phase 1 clinical development. All completed trials for AZD8566 were Phase 1 studies conducted in healthy volunteers. The drug is investigational and has not received regulatory approval.

What clinical trials is AZD8566 in?

AZD8566 has been studied in three completed Phase 1 trials: NCT00749333, a single ascending dose study; NCT00844103, a multiple ascending dose study; and NCT00866385, a food effect and microtracer study. All trials were conducted in the United Kingdom with healthy volunteers.

Is AZD8566 FDA approved?

AZD8566 is not FDA approved. It is an investigational drug that has only been studied in Phase 1 clinical trials in healthy volunteers. These trials were designed to assess safety, tolerability, and pharmacokinetics, not to support an approval application.