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Completed

NCT Number: NCT01335451

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

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

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Key information

Conditions

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Centre

Fukuoka, Japan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AZD5213

Drug

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

Drug

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

Primary outcomes

  1. 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

Secondary outcomes

  1. To assess the PK of AZD5213 after a single and multiple doses by assessment of Cmax.

    Time frame: Range of Days 1-12

  2. To assess the PK of AZD5213 after a single and multiple doses by assessment of fe.

    Time frame: Range of Days 1-12

  3. To assess the PK of AZD5213 after a single and multiple doses by assessment of CLR.

    Time frame: Range of Days 1-12

  4. To assess the PK of AZD5213 after a single and multiple doses by assessment of CL/F.

    Time frame: Range of Days 1-12

  5. To assess the PK of AZD5213 after a single and multiple doses by assessment of t1/2.

    Time frame: Range of Days 1-12

  6. To assess the PK of AZD5213 after a single and multiple doses by assessment of tmax.

    Time frame: Range of Days 1-12

  7. To assess the PK of AZD5213 after a single and multiple doses by assessment of AUC.

    Time frame: Range of Days 1-12

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Apr 14, 2011
Registry last updated
Jan 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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