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Completed

NCT Number: NCT00844103

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

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.

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Key information

Conditions

Pharmacokinetics

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Macclesfield, Cheshire, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AZD8566

Drug

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

Placebo

Drug

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

Primary outcomes

  1. Pharmacokinetic profile: concentration of AZD8566 in blood

    Time frame: Samples taken during Visit 2 (residential period) at up to 15 defined timepoints pre-dose and post- dose on Day 1 and Day 10

  2. Safety and tolerability of AZD8566 by assessment of vital signs, laboratory variables, ECG and adverse events

    Time frame: 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 outcomes

  1. Pharmacokinetic profile: concentration of AZD8566 in urine

    Time frame: Samples collected over 48 hours from pre-dose to 48 hours post-dose on Day 1 and Day 10.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Feb 13, 2009
Registry last updated
Apr 30, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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