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

Sponsor

AstraZeneca (Industry)

Overall Status

Completed

CT.gov ID

NCT00684502

Collaborator

(none)

110

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Pain	Drug: AZD2066 Drug: Placebo	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

110 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Basic Science

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

Study Start Date :

Jan 1, 2008

Actual Primary Completion Date :

Nov 1, 2008

Actual Study Completion Date :

Nov 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Oral solution.	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 Comparator: 2 Oral solution	Drug: Placebo Administered orally as a solution once per day on day 1, and then day 3 through to day 12.

Arm

Intervention/Treatment

Experimental: 1

Oral solution.

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 Comparator: 2

Oral solution

Drug: Placebo

Administered orally as a solution once per day on day 1, and then day 3 through to day 12.

Outcome Measures

Primary Outcome Measures

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]

Secondary Outcome Measures

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.]
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.]
Investigate CNS effects of AZD2066 [Psychometric test battery performed at defined timepoints during the residential period. Test on day -1 for training purposes.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Site	Stockholm		Sweden

Sponsors and Collaborators

AstraZeneca

Investigators

Principal Investigator: Bo Fransson, MD, AstraZeneca R&D SödertäljeMedical Science, CPU C2:84Karolinska University Hospital HuddingeSE-141 86 Stockholm, Sweden
Study Chair: Lars Stahle, MD, PhD, AstraZeneca R&D Södertälje Medical Science S-151 85 Södertälje Sweden