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

A Single Centre Two Part Randomized Phase I Study to Assess the Pharmacokinetics of an ER Formulation of AZD2516 and to Assess the Safety, Tolerability and Pharmacokinetics of AZD2516 After Multiple Ascending Doses in Healthy Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01148095

Enrollment

Registered

2010-06-22

Start date

2010-06-30

Completion date

2010-07-31

Last updated

2011-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

Keywords

AZD2516, Phase 1, Healthy volunteer, pharmacokinetics, safety, tolerability, Multiple ascending doses

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.

Interventions

DRUGAZD2516

Oral, single, daily, 11 days

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

20 Years to 80 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Adverse Events, vital signs	Day -1 until follow-up

Secondary

Measure	Time frame
Maximum plasma concentration (Cmax)	Day 1 - Day 12
Time to Cmax (tmax)	Day 1 - Day 12
Terminal rate constant (λz)	Day 1 - Day 12

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026