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

AstraZeneca logo

AstraZeneca

Status and phase

Completed
Phase 1

Conditions

Pain

Treatments

Drug: Placebo
Drug: AZD2066

Study type

Interventional

Funder types

Industry

Identifiers

NCT00684502
D0475C00002
EudractCT 2007-005524-33

Details and patient eligibility

About

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.

Enrollment

110 patients

Sex

All

Ages

20 to 80 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

110 participants in 2 patient groups, including a placebo group

1
Experimental group
Description:
Oral solution.
Treatment:
Drug: AZD2066
2
Placebo Comparator group
Description:
Oral solution
Treatment:
Drug: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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