To Investigate the Safety, Tolerability and Pharmacokinetics of AZD2516 After Multiple Dosing 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

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2010-07-31

Brief Summary

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AZD2516 is being developed for the oral treatment of chronic neuropathic pain. This study is split in to two parts. Part A will measure the effect of food and a new formulation of the drug in the blood and see how well it is tolerated. Part B will commence after the completion of Part A and will investigate the safety and tolerability of daily dosing with AZD2516.

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Detailed Description

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Conditions

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Part A Healthy Young Males and Non-fertile Female Volunteers Aged 20 to 45 Years. Part B Healthy Young Males and Non-fertile Female Volunteers Aged 20 to 45 and Elderly Volunteers Aged 60 to 80

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

AZD2516 (dose escalating)

Group Type EXPERIMENTAL

AZD2516

Intervention Type DRUG

Oral, single, daily, 11 days

2

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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AZD2516

Oral, single, daily, 11 days

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Have a body mass index (BMI) between 18 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg
* Healthy volunteers able and willing to comply with all study requirements.

Exclusion Criteria

* An ongoing or history of a medical or psychiatric disease/condition which may put the healthy volunteer at risk or interfere with the study objectives because of participation in the study, as judged by the investigator(s).
* History of psychotic disorder among first degree relatives.

Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes