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

Healthy Volunteer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00749333
• Other study ID #: D1320C00001
• Status: Completed
• Phase: Phase 1
• First received: September 5, 2008
• Last updated: April 29, 2009
• Start date: August 2008
• Est. completion date: February 2009

Study information

• Verified date: April 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: February 2009
• Est. primary completion date: February 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 postmenopausal.

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• AZD8566
solution. Specific dose will be selected by the safety review committee
• Placebo
Single 10ml oral solution.

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		Samples taken during Visit 2 (residential period) at up to 16 defined timepoints pre-dose and post- dose	No
Primary	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.	Yes
Secondary	Pharmacokinetic profile: concentration of AZD8566 in urine		Samples collected over 48 hours from pre-dose to 48 hours post-dose.	No