Assess the Safety, Tolerability and Pharmacokinetics of AZD5213 After Single and Multiple Ascending Oral Doses in Healthy Young and Elderly Japanese Subjects

Sponsor

AstraZeneca (Industry)

Overall Status

Completed

CT.gov ID

NCT01335451

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to investigate the safety, tolerability and pharmacokinetics of AZD5213 in healthy young and elderly Japanese subjects

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: AZD5213 Drug: Placebo	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

48 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

A Phase I, Single Centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD5213 After Oral Administration of Single and Multiple Ascending Doses in Healthy Young and Elderly J

Study Start Date :

Apr 1, 2011

Actual Primary Completion Date :

Oct 1, 2011

Actual Study Completion Date :

Oct 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Active Each cohort will have 6 subjects that will receive AZD5213	Drug: AZD5213 Four increasing doses for young and two increasing doses for elderly subjects. Subject will receive single dose of AZD5213 oral solution (Day 1) and then start the once daily repeated doses from Day 3 to 12 for 10 days
Placebo Comparator: Placebo Each cohort will have 2 subjects that will receive placebo	Drug: Placebo Placebo solution, single dose (Day 1) and repeated dose from Day 3 to 12 for 10 days

Arm

Intervention/Treatment

Experimental: Active

Each cohort will have 6 subjects that will receive AZD5213

Drug: AZD5213

Four increasing doses for young and two increasing doses for elderly subjects. Subject will receive single dose of AZD5213 oral solution (Day 1) and then start the once daily repeated doses from Day 3 to 12 for 10 days

Placebo Comparator: Placebo

Each cohort will have 2 subjects that will receive placebo

Drug: Placebo

Placebo solution, single dose (Day 1) and repeated dose from Day 3 to 12 for 10 days

Outcome Measures

Primary Outcome Measures

To assess the safety and tolerability of AZD5213 by assessment of adverse event, vital signs, laboratory parameters and electrocardiograms (ECGs). [Range of Days 1-12]

Secondary Outcome Measures

To assess the PK of AZD5213 after a single and multiple doses by assessment of Cmax. [Range of Days 1-12]
To assess the PK of AZD5213 after a single and multiple doses by assessment of fe. [Range of Days 1-12]
To assess the PK of AZD5213 after a single and multiple doses by assessment of CLR. [Range of Days 1-12]
To assess the PK of AZD5213 after a single and multiple doses by assessment of CL/F. [Range of Days 1-12]
To assess the PK of AZD5213 after a single and multiple doses by assessment of t1/2. [Range of Days 1-12]
To assess the PK of AZD5213 after a single and multiple doses by assessment of tmax. [Range of Days 1-12]
To assess the PK of AZD5213 after a single and multiple doses by assessment of AUC. [Range of Days 1-12]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Provision of signed and dated, written informed consent prior to any study specific procedures
Japanese healthy male subjects aged 20 to 45 years (young) and male and female subjects aged 65 to 80 years (elderly)
Male subjects should be willing to use barrier contraception ie, condoms, from the first day of dosing until 3 months after the last dose of investigational product
Have a body mass index (BMI) between 17 and 27 kg/m2 and weigh at least 45 kg and no more than 100 kg
Clinically normal physical findings, supine BP, pulse rate, ECG and laboratory assessments in relation to age, as judged by the investigator(s)

Exclusion Criteria:

History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study
History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs
History of previous or ongoing psychiatric disease/condition including psychosis, affective disorder, anxiety disorder, and personality disorder including borderline according to the criteria in the Diagnostic and Statistical Manual of Mental Disorders
History of psychotic disorder among first degree relatives.
History of use of antipsychotic, antidepressant or anxiolytic drugs, prescribed as well as non-prescribed use.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Centre	Fukuoka		Japan

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director: Märta Segerdahl, MD, PhD, AstraZeneca R&D, Södertälje
Principal Investigator: Akimasa Watanabe, MD, Kyushu Clinical Pharmacology Research Clinic, Japan