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

This study has been completed.
Sponsor:
Collaborator:
Quintiles
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01148095
First received: June 18, 2010
Last updated: February 6, 2011
Last verified: February 2011
  Purpose

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.


Condition Intervention Phase
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
Drug: AZD2516
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Adverse Events, vital signs [ Time Frame: Day -1 until follow-up ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Maximum plasma concentration (Cmax) [ Time Frame: Day 1 - Day 12 ] [ Designated as safety issue: No ]
  • Time to Cmax (tmax) [ Time Frame: Day 1 - Day 12 ] [ Designated as safety issue: No ]
  • Terminal rate constant (λz) [ Time Frame: Day 1 - Day 12 ] [ Designated as safety issue: No ]

Enrollment: 6
Study Start Date: June 2010
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
AZD2516 (dose escalating)
Drug: AZD2516
Oral, single, daily, 11 days
Placebo Comparator: 2
Placebo
Drug: Placebo

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01148095

Locations
United Kingdom
Research Site
London, United Kingdom
Sponsors and Collaborators
AstraZeneca
Quintiles
Investigators
Principal Investigator: Darren Wilbraham, MBBS, DCPSA Quintiles Drug Research Unit 6, Newcomen Street, London, SE1 1YR
  More Information

No publications provided

Responsible Party: MSD, AstraZeneca
ClinicalTrials.gov Identifier: NCT01148095     History of Changes
Other Study ID Numbers: D2080C00002
Study First Received: June 18, 2010
Last Updated: February 6, 2011
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by AstraZeneca:
AZD2516
Phase 1
Healthy volunteer
pharmacokinetics
safety
tolerability
Multiple ascending doses

ClinicalTrials.gov processed this record on October 19, 2014