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

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 Overview

• Status: 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
• Intervention / Treatment: Drug: Placebo; Drug: AZD2516

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 2; Placebo	Drug: Placebo
Experimental: 1; AZD2516 (dose escalating)	Drug: AZD2516; Oral, single, daily, 11 days

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: AstraZeneca
• Collaborators: Quintiles, Inc.
• Investigators: Principal Investigator: Darren Wilbraham, MBBS, DCPSA, Quintiles Drug Research Unit 6, Newcomen Street, London, SE1 1YR

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (Actual): July 1, 2010
• Study Completion (Actual): July 1, 2010

Study Registration Dates

• First Submitted: June 18, 2010
• First Submitted That Met QC Criteria: June 18, 2010
• First Posted (Estimate): June 22, 2010

Study Record Updates

• Last Update Posted (Estimate): February 8, 2011
• Last Update Submitted That Met QC Criteria: February 6, 2011
• Last Verified: February 1, 2011

More Information

Terms related to this study

• Keywords: tolerability; safety; pharmacokinetics; Phase 1; Multiple ascending doses; Healthy volunteer; AZD2516
• Other Study ID Numbers: D2080C00002