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A Two-part Single and Multiple Dose Study to Assess the Safety , Pharmacokinetics and Effects of AZD3293 in Healthy Japanese Young and Elderly Volunteers

NCT ID: NCT02005211

Last Updated: 2016-11-04

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

114 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2014-07-31

Brief Summary

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This study consists of two parts, ie, single dose part with young healthy subjects (Part 1) and single and multiple dose part with elderly healthy subjects (Part 2), to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of AZD3293 following single and multiple ascending dose administration to healthy subjects.

Detailed Description

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This is a Phase I, randomised, double-blind, placebo-controlled, single centre study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of AZD3293 following single and multiple ascending dose administration to healthy subjects. This study consists of two parts, ie, single dose part with young healthy subjects (Part 1) and single and multiple dose part with elderly healthy subjects (Part 2). The study design allows a gradual escalation of dosage levels between sequential cohorts with safety monitoring to ensure the safety of the healthy subjects.

Conditions

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Healthy Japanese Young and Elderly Male and Non-fertile Female Volunteers

Keywords

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AZD3293 Healthy volunteers Young volunteers Elderly volunteers Japanese volunteers Phase 1 Single and multiple ascending dose study

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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AZD3293

AZD3293 will be administered as single dose of an oral solution in Part 1 and single and multiple doses of an oral solution in Part 2. The ascending doses are planned to be 15, 50 and 150 mg for young subjects in Part 1 and 15 and 50 mg for elderly subjects in Part 2. Before proceeding to next dose level, safety, tolerability and pharmacokinetic data from the previous cohort(s) will be evaluated by a Safety Review Committee. Part 2 will start after confirming safety and tolerability in Part 1.

Group Type EXPERIMENTAL

AZD3293

Intervention Type DRUG

Oral solution

Placebo

Placebo given (2 subjects in each cohort)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Oral solution

Interventions

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AZD3293

Oral solution

Intervention Type DRUG

Placebo

Oral solution

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy Japanese elderly and young males and females (of non-childbearing potential)
* Body mass index (BMI) between 17 and 27 kg/m2 and weigh at least 40 kg and no more than 100 kg

Exclusion Criteria

* Psychiatric disease/condition, GI, renal, hepatic, cardiovascular, psychiatric, or retinal diseases or disorders
* Use of antipsychotic drugs , or chronic use of antidepressant or anxiolytic drugs.
* Frequent use (more than 2 days per week during the last 12 weeks) of tobacco or other nicotine products.
* Neurological disease, including seizures, recent memory impairment, or clinically significant head injury.
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Robert C Alexander, MD

Role: STUDY_DIRECTOR

AstraZeneca

Kei Sakamoto, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Sugioka Memorial Hospital, Medical Co. LTA

Locations

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Research Site

Fukuoka, , Japan

Site Status

Countries

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Japan

Other Identifiers

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D5010C00003

Identifier Type: -

Identifier Source: org_study_id