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

NCT00766012 | Completed Phase 1

• 1 other identifier: D0475C00004
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Keywords

safety; tolerability; pharmacokinetics; AZD2066; Japanese

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability 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 (2)

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

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

• Investigate CNS effects of AZD2066 in Japanese healthy male subjects

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

Study Arms (2)

1

EXPERIMENTAL

4 dose panels receiving a specified volume of AZD2066 oral solution once daily for 11 days

Drug: AZD2066

2

PLACEBO COMPARATOR

Included in each dose panel

Drug: Placebo

Interventions

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.

1

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.

2

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

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) within first 2 weeks before first administration of study drug.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research SIte

Fukuoka, Japan

Location

MeSH Terms

Interventions

AZD2066

Study Officials

• Anders Neijber

  AstraZeneca R&D Södertälje, Sweden

  STUDY DIRECTOR

• Shin Irie

  Kyusyu Clinical Phramacology Research Clinic

  PRINCIPAL INVESTIGATOR

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: October 2, 2008
• First Posted: October 3, 2008
• Study Start: September 1, 2008
• Study Completion: July 1, 2009
• Last Updated: August 25, 2009

Record last verified: 2009-08

Locations

JP (1)