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

AstraZeneca

Status and phase

Completed

Phase 1

Conditions

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

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

Treatments

Drug: Placebo

Drug: AZD2516

Study type

Interventional

Funder types

Industry

Identifiers

NCT01148095

D2080C00002

Details and patient eligibility

About

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.

Enrollment

6 patients

Sex

All

Ages

20 to 80 years old

Volunteers

Accepts Healthy Volunteers

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.