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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01335451
• Other study ID #: D3030C00004
• Status: Completed
• Phase: Phase 1
• First received: April 13, 2011
• Last updated: January 27, 2015
• Start date: April 2011
• Est. completion date: October 2011

Study information

• Verified date: January 2015
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationJapan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy

Intervention

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

Locations

Country	Name	City	State
Japan	Research Centre	Fukuoka

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	To assess the PK of AZD5213 after a single and multiple doses by assessment of Cmax.		Range of Days 1-12	No
Secondary	To assess the PK of AZD5213 after a single and multiple doses by assessment of fe.		Range of Days 1-12	No
Secondary	To assess the PK of AZD5213 after a single and multiple doses by assessment of CLR.		Range of Days 1-12	No
Secondary	To assess the PK of AZD5213 after a single and multiple doses by assessment of CL/F.		Range of Days 1-12	No
Secondary	To assess the PK of AZD5213 after a single and multiple doses by assessment of t1/2.		Range of Days 1-12	No
Secondary	To assess the PK of AZD5213 after a single and multiple doses by assessment of tmax.		Range of Days 1-12	No
Secondary	To assess the PK of AZD5213 after a single and multiple doses by assessment of AUC.		Range of Days 1-12	No

External Links

•   D3030C00004_Clinical_Study_Report_Synopsis.pdf