Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD2066 in Young and Elderly Healthy Subjects

Pain Clinical Trial

Official title:

A Phase I, Single-centre, Randomised, Double-blind, Parallel Group, Placebo-controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD2066 in Young and Elderly Healthy Subjects After Oral Multiple Ascending Doses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00684502
• Other study ID #: D0475C00002
• Secondary ID: EudractCT 2007-0
• Status: Completed
• Phase: Phase 1
• First received: May 22, 2008
• Last updated: December 8, 2010
• Start date: January 2008
• Est. completion date: November 2008

Study information

• Verified date: December 2008
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products AgencySweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate the safety and tolerability of AZD2066 using multiple escalating dose panels. There will be separate panels for young healthy volunteers and elderly healthy volunteers. Each panel will contain 10 volunteers who will randomly receive AZD2066 or placebo. One panel will be run at a time with a fixed dose given. After the completion of each panel, a Safety Review Committee will decide if the study can proceed to the next dose panel.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• Provision of signed informed consent

• Clinically normal physical findings and laboratory values as judged by the investigator and a normal resting ECG.

Exclusion Criteria:

• History of somatic disease/condition, which may interfere with the objectives of the study, as judged by the investigator.

• History of previous or ongoing psychiatric disease/condition including psychosis, affective disorder, anxiety disorder, borderline state and personality disorder.

• Intake of medicine (except occasional paracetamol or nasal spray) within first 2 weeks before first administration of 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

• Pain

Intervention

Drug:
• AZD2066
Oral solution administered orally once per day on day 1, and then day 3 through to day 12. Specific dose depends on dose panel.
• Placebo
Administered orally as a solution once per day on day 1, and then day 3 through to day 12.

Locations

Country	Name	City	State
Sweden	Research Site	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability of AZD2066 by assessment of vital signs, laboratory variables and ECG		Assessments taken at visit 1 (enrolment), defined time points pre dose and post dose during visit 2 (residential period): days -1 through to day 15 and follow up visit 3	Yes
Secondary	Safety and tolerability of AZD2066 by assessment of adverse events		Non serious adverse events will be collected from the start of Visit 2 until the end of the study. Serious adverse events will be collected from signing of consent until end of study.	Yes
Secondary	Investigate PK profile (including dose proportionality, degree of accumulation and time dependancy) of AZD2066 (and possible relevant metabolites).		PK sampling taken at defined timepoints during residential period and follow-up.	No
Secondary	Investigate CNS effects of AZD2066		Psychometric test battery performed at defined timepoints during the residential period. Test on day -1 for training purposes.	No