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

AstraZeneca6 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

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

Interventions

Eligibility

Sex: ALLMin age: 20 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Adverse Events, vital signs

Time frame: Day -1 until follow-up

Secondary Outcomes

Maximum plasma concentration (Cmax)

Time frame: Day 1 - Day 12

Time to Cmax (tmax)

Time frame: Day 1 - Day 12

Terminal rate constant (λz)

Time frame: Day 1 - Day 12

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes