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

NCT00684502 | Completed Phase 1 DMC

• 2 other identifiers: D0475C00002EudractCT 2007-005524-33
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Keywords

Safety; tolerability; AZD2066; Pain conditions

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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.

Study Arms (2)

1

EXPERIMENTAL

Oral solution.

Drug: AZD2066

2

PLACEBO COMPARATOR

Oral solution

Drug: Placebo

Interventions

AZD2066 DRUG

Oral solution administered orally once per day on day 1, and then day 3 through to day 12. Specific dose depends on dose panel.

1

Placebo DRUG

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

2

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of signed informed consent
• Clinically normal physical findings and laboratory values as judged by the investigator and a normal resting ECG.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Stockholm, Sweden

Location

MeSH Terms

Conditions

Pain

Interventions

AZD2066

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Bo Fransson, MD

  AstraZeneca R&D SödertäljeMedical Science, CPU C2:84Karolinska University Hospital HuddingeSE-141 86 Stockholm, Sweden

  PRINCIPAL INVESTIGATOR

• Lars Stahle, MD, PhD

  AstraZeneca R&D Södertälje Medical Science S-151 85 Södertälje Sweden

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: May 22, 2008
• First Posted: May 26, 2008
• Study Start: January 1, 2008
• Primary Completion: November 1, 2008
• Study Completion: November 1, 2008
• Last Updated: December 10, 2010

Record last verified: 2008-12

Locations

SE (1)