Clinical trial NCT01335451: Assess the Safety, Tolerability and Pharmacokinetics of AZD5213 After Single and Multiple Ascending Oral Doses in Healthy Young and Elderly Japanese Subjects
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: AZD5213
safety
pharmacokinetics
single dose
repeated dose
young
elderly
Japanese
healthy subject
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2011-04-14
Enrollment: 48
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: To assess the safety and tolerability of AZD5213 by assessment of adverse event, vital signs, laboratory parameters and electrocardiograms (ECGs).
timeFrame: Range of Days 1-12
Secondary outcomes:
measure: To assess the PK of AZD5213 after a single and multiple doses by assessment of Cmax.
timeFrame: Range of Days 1-12
measure: To assess the PK of AZD5213 after a single and multiple doses by assessment of fe.
timeFrame: Range of Days 1-12
measure: To assess the PK of AZD5213 after a single and multiple doses by assessment of CLR.
timeFrame: Range of Days 1-12
measure: To assess the PK of AZD5213 after a single and multiple doses by assessment of CL/F.
timeFrame: Range of Days 1-12
measure: To assess the PK of AZD5213 after a single and multiple doses by assessment of t1/2.
timeFrame: Range of Days 1-12
measure: To assess the PK of AZD5213 after a single and multiple doses by assessment of tmax.
timeFrame: Range of Days 1-12
measure: To assess the PK of AZD5213 after a single and multiple doses by assessment of AUC.
timeFrame: Range of Days 1-12
Other outcomes:
Locations:
city: Fukuoka
country: Japan
facility: Research Centre
Study officials:
affiliation: AstraZeneca R&D, Södertälje
name: Märta Segerdahl, MD, PhD
role: STUDY_DIRECTOR
affiliation: Kyushu Clinical Pharmacology Research Clinic, Japan
name: Akimasa Watanabe, MD
role: PRINCIPAL_INVESTIGATOR
References: