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

Phase 1

Completed

• Conditions: Healthy Volunteer
• Interventions: Drug: AZD8566; Drug: Placebo

• Registration Number: NCT00749333
• Lead Sponsor: AstraZeneca

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-08
• Study First Submitted: 2008-09-05
• Study First Submitted QC: 2008-09-08
• Study First Posted: 2008-09-09
• Primary Completion: 2009-02
• Study Completion: 2009-02
• Status Verified: 2009-04
• Last Update Submitted: 2009-04-29
• Last Update Posted: 2009-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 108

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	AZD8566	-
2	Placebo	-

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic profile: concentration of AZD8566 in blood	Samples taken during Visit 2 (residential period) at up to 16 defined timepoints pre-dose and post- dose
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 Outcome Measures

Name	Time	Method
Pharmacokinetic profile: concentration of AZD8566 in urine	Samples collected over 48 hours from pre-dose to 48 hours post-dose.

Trial Locations

Locations (1)

Research Site; 🇬🇧 Nottingham, United Kingdom