Study to Investigate the Safety, Tolerability and Pharmacokinetics of Multiple Doses of AZD8566.

A Phase I, Randomised, Double Blind, Placebo-Controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of Multiple Oral Doses of AZD8566 in Healthy Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00844103

Enrollment

Registered

2009-02-13

Start date

2009-01-31

Completion date

2009-04-30

Last updated

2009-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pharmacokinetics

Keywords

Volunteer, Safety, Tolerability, AZD8566

Brief summary

The purpose of this study is to determine how well tolerated and safe AZD8566 is when given over 10 days, at different dose levels. This study will also determine how AZD8566 is distributed around the body and how it leaves the body.

Interventions

DRUGAZD8566

10ml oral solution administered once a day over 10 days. Specific dose will be selected by the safety review committee

DRUGPlacebo

10ml oral solution administered once a day over 10 days.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

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 postmenopausal and males.

Exclusion criteria

* Intake of medicine (except Hormone Replacement Therapy or occasional paracetamol) within 3 weeks before first administration of study drug * History of any convulsions or seizures * History of infection or at risk of infection due to recent surgery or trauma * History or presence of conditions known to interfere with the absorption, distribution, metabolism and excretion of the study drug

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Pharmacokinetic profile: concentration of AZD8566 in urine	Samples collected over 48 hours from pre-dose to 48 hours post-dose on Day 1 and Day 10.

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026