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

NCT00844103 | Completed Phase 1

• 1 other identifier: D1320C00002
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Pharmacokinetics

Keywords

Volunteer; Safety; Tolerability; AZD8566

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• 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.

Study Arms (2)

1

EXPERIMENTAL

Drug: AZD8566

2

PLACEBO COMPARATOR

Drug: Placebo

Interventions

AZD8566 DRUG

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

1

Placebo DRUG

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

2

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Macclesfield, Cheshire, United Kingdom

Location

Study Officials

• Emeline Ramos, MD

  Clinical Pharmacology Unit

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 12, 2009
• First Posted: February 13, 2009
• Study Start: January 1, 2009
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: April 30, 2009

Record last verified: 2009-04

Locations

GB (1)