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

NCT01335451 | Completed Phase 1

• 1 other identifier: D3030C00004
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Keywords

AZD5213; safety; pharmacokinetics; single dose; repeated dose; young; elderly; Japanese; healthy subject

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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 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 t1/2.

  Range of Days 1-12

Study Arms (2)

Active

EXPERIMENTAL

Each cohort will have 6 subjects that will receive AZD5213

Drug: AZD5213

Placebo

PLACEBO COMPARATOR

Each cohort will have 2 subjects that will receive placebo

Drug: Placebo

Interventions

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

Active

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Centre

Fukuoka, Japan

Location

Related Links

• D3030C00004\_Clinical\_Study\_Report\_Synopsis.pdf

Study Officials

• Märta Segerdahl, MD, PhD

  AstraZeneca R&D, Södertälje

  STUDY DIRECTOR

• Akimasa Watanabe, MD

  Kyushu Clinical Pharmacology Research Clinic, Japan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2011
• First Posted: April 14, 2011
• Study Start: April 1, 2011
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: January 28, 2015

Record last verified: 2015-01

Locations

JP (1)