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

Healthy Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00766012
• Other study ID #: D0475C00004
• Status: Completed
• Phase: Phase 1
• First received: October 2, 2008
• Last updated: August 24, 2009
• Start date: September 2008
• Est. completion date: July 2009

Study information

• Verified date: August 2009
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: July 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 45 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• AZD2066
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
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.

Locations

Country	Name	City	State
Japan	Research SIte	Fukuoka

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	No
Secondary	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.	No