To Investigate the Safety, Tolerability and Pharmacokinetics of AZD2516 After Multiple Dosing in Healthy Volunteers
Phase 1
Completed
- 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
- Drug: Placebo
- Registration Number
- NCT01148095
- Lead Sponsor
- AstraZeneca
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 6
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 AZD2516 AZD2516 (dose escalating) 2 Placebo Placebo
- Primary Outcome Measures
Name Time Method Adverse Events, vital signs Day -1 until follow-up
- Secondary Outcome Measures
Name Time Method Maximum plasma concentration (Cmax) Day 1 - Day 12 Time to Cmax (tmax) Day 1 - Day 12 Terminal rate constant (λz) Day 1 - Day 12
Trial Locations
- Locations (1)
Research Site
🇬🇧London, United Kingdom