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Completed

NCT Number: NCT00766012

Study to Assess the Safety, Tolerability and Pharmacokinetics After Multiple Doses of AZD2066 in Japanese Subjects

The purpose of this study is to investigate the safety, tolerability and pharmacokinetics of AZD2066 when given as multiple doses to Japanese healthy male subjects. Four (4) consecutive multiple-ascending panels are planned. Subjects will start with an initial single dose that is followed by a wash-out period of 48 hours to adequately define the single-dose pharmacokinetics. For the third and forth dose panels, the wash-out period will be extended to be 96 hours to evaluate the safety of subjects. Thereafter the subjects will be dosed once daily for 10 days. Ten (10) subjects will be allocated to each dose panel and randomized to receive either AZD2066 or placebo.

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Key information

Conditions

Age range

20 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Research SIte

Fukuoka, Japan

About this study

The purpose of this study is to investigate the safety, tolerability and pharmacokinetics of AZD2066 when given as multiple doses to Japanese healthy male subjects. Four (4) consecutive multiple-ascending panels are planned. Subjects will start with an initial single dose that is followed by a wash-out period of 48 hours to adequately define the single-dose pharmacokinetics. For the third and forth dose panels, the wash-out period will be extended to be 96 hours to evaluate the safety of subjects. Thereafter the subjects will be dosed once daily for 10 days. Furthermore, the study has been expanded to include two additional panels with increment of dose during the multiple dosing period (12 days) in order to obtain sufficient information on safety and tolerability of multiple dosing of AZD2066 in Japanese subjects at higher levels of exposure. Ten (10) subjects will be allocated to each dose panel and randomized to receive either AZD2066 or placebo.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Provision of signed informed consent
  • Healthy Japanese males as judged by the investigator
  • 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) within first 2 weeks before first administration of study drug.

Treatment and study plan

AZD2066

Drug

Oral solution administered orally once per day on day 1, and then day 3 through to day 12 for the first and second dose panels and day 5 through to day 14 for the third and fourth dose panels. For the fifth and sixth panels, oral solution administered once per day on day 1, and then day 5 through to day 16. Specific dose depends on dose panel.

Placebo

Drug

Oral solution administered orally once per day on day 1, and then day 3 through to day 12 for the first and second dose panels and day 5 through to day 14 for the third and fourth dose panels. For the fifth and sixth panels, oral solution administered once per day on day 1, and then day 5 through to day 16.

Primary outcomes

  1. Safety and tolerability by assessment of vital signs, laboratory variables and ECG

    Time frame: 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

  1. Investigate pharmacokinetic profile (including dose proportionality, degree of accumulation and time dependancy) of AZD2066 in Japanese healthy male subjects

    Time frame: Blood sampling at defined timepoints during residential period and follow-up

  2. Investigate CNS effects of AZD2066 in Japanese healthy male subjects

    Time frame: Psychometric test battery performed at defined timepoints during the residential period. Test on day -1 for training purposes.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Study completion
2009
First posted
Oct 3, 2008
Registry last updated
Aug 25, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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