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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Placebo; Drug: AZD5213

• Registration Number: NCT01335451
• Lead Sponsor: AstraZeneca

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-04
• Study First Submitted: 2011-04-13
• Study First Submitted QC: 2011-04-13
• Study First Posted: 2011-04-14
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-27
• Last Update Posted: 2015-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Each cohort will have 2 subjects that will receive placebo
Active	AZD5213	Each cohort will have 6 subjects that will receive AZD5213

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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 t1/2.	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
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 tmax.	Range of Days 1-12

Trial Locations

Locations (1)

Research Centre; 🇯🇵 Fukuoka, Japan