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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01335451
First received: April 13, 2011
Last updated: October 27, 2011
Last verified: October 2011
  Purpose

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


Condition Intervention Phase
Healthy
Drug: AZD5213
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • To assess the safety and tolerability of AZD5213 by assessment of adverse event, vital signs, laboratory parameters and electrocardiograms (ECGs). [ Time Frame: Range of Days 1-12 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To assess the PK of AZD5213 after a single and multiple doses by assessment of Cmax. [ Time Frame: Range of Days 1-12 ] [ Designated as safety issue: No ]
  • To assess the PK of AZD5213 after a single and multiple doses by assessment of fe. [ Time Frame: Range of Days 1-12 ] [ Designated as safety issue: No ]
  • To assess the PK of AZD5213 after a single and multiple doses by assessment of CLR. [ Time Frame: Range of Days 1-12 ] [ Designated as safety issue: No ]
  • To assess the PK of AZD5213 after a single and multiple doses by assessment of CL/F. [ Time Frame: Range of Days 1-12 ] [ Designated as safety issue: No ]
  • To assess the PK of AZD5213 after a single and multiple doses by assessment of t1/2. [ Time Frame: Range of Days 1-12 ] [ Designated as safety issue: No ]
  • To assess the PK of AZD5213 after a single and multiple doses by assessment of tmax. [ Time Frame: Range of Days 1-12 ] [ Designated as safety issue: No ]
  • To assess the PK of AZD5213 after a single and multiple doses by assessment of AUC. [ Time Frame: Range of Days 1-12 ] [ Designated as safety issue: No ]

Enrollment: 48
Study Start Date: April 2011
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01335451

Locations
Japan
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
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01335451     History of Changes
Other Study ID Numbers: D3030C00004
Study First Received: April 13, 2011
Last Updated: October 27, 2011
Health Authority: United States: Food and Drug Administration
Japan: Ministry of Health, Labor and Welfare

Keywords provided by AstraZeneca:
AZD5213
safety
pharmacokinetics
single dose
repeated dose
young
elderly
Japanese
healthy subject

ClinicalTrials.gov processed this record on April 17, 2014