Study to Investigate Safety, Tolerability and Pharmacokinetics of AZD2423 Multiple Doses in Healthy Volunteers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2010-05-31

Brief Summary

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Three-part study investigating the safety and tolerability of AZD2423 multiple doses in 98 healthy volunteers: Part 1 80 young and elderly subjects in a parallel, double blind, randomised study. Part 2 - 6 subjects in an open, non-randomised study. Part 3 - 12 subjects in a three-way cross over, open label, partially randomised study.

Part 1 has 2 Arms, AZD2423 or Placebo, Multiple dosing during 10-14 days . Part 2 has 1 Arm AZD2423 Multiple dosing and Part 3 has 3 Arms AZD2423 single dosing or AZD2423 single dosing with food or AZD2423 single dosing, Fasting Condition

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Part 1 AZD2423 or Placebo

AZD2423 or Placebo Oral Solution, multiple dosing during 10-14 days

Group Type EXPERIMENTAL

Part 1 - AZD2423 or Placebo

Intervention Type DRUG

AZD2423 Oral Solution, multiple dosing during 10-14 days or Placebo Oral Solution, multiple dosing during 10-14 days

Part 2 - AZD2423

AZD2423 Oral solution, multiple dosing

Group Type EXPERIMENTAL

Part 2 - AZD2423

Intervention Type DRUG

AZD2423 Oral solution, multiple dosing

Part 3 - AZD2423

AZD2423 Oral solution single dosing or AZD2423 Oral solution, single dosing - With Food or AZD2423 Oral solution, single dosing - Fasting Condition.

Group Type EXPERIMENTAL

Part 3 - AZD2423

Intervention Type DRUG

AZD2423 Oral solution, single dosing or AZD2423 Oral solution, single dosing - With Food or AZD2423 Oral solution, single dosing - Fasting Condition.

Interventions

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Part 1 - AZD2423 or Placebo

AZD2423 Oral Solution, multiple dosing during 10-14 days or Placebo Oral Solution, multiple dosing during 10-14 days

Intervention Type DRUG

Part 2 - AZD2423

AZD2423 Oral solution, multiple dosing

Intervention Type DRUG

Part 3 - AZD2423

AZD2423 Oral solution, single dosing or AZD2423 Oral solution, single dosing - With Food or AZD2423 Oral solution, single dosing - Fasting Condition.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Provision of signed and dated, written informed consent prior to any study specific procedures
* Healthy male and non-fertile female subjects aged ≥20 to ≤55 years inclusive and healthy male and female subjects aged ≥65 to ≤80 years inclusive with suitable veins for cannulation or repeated venepuncture.
* Have a body mass index (BMI) between ≥18 and ≤30 kg/m2, as calculated by the investigator, and weigh at least 50 kg and no more than 100 kg.
* Clinically normal physical findings including supine blood pressure, pulse rate, ECG, and laboratory assessments in relation to age, as judged by the investigator. In addition, normal ophthalmoscopy is required for the CSF panel subjects (Part 2).

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.
* Any clinically significant illness/infection or medical/surgical procedure or trauma, as judged by the Principal Investigator, within 3 months of the first administration of investigational product.

Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes