NCT01148095

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jun 2010

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

June 18, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 22, 2010

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
Last Updated

February 8, 2011

Status Verified

February 1, 2011

Enrollment Period

1 month

First QC Date

June 18, 2010

Last Update Submit

February 6, 2011

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

AZD2516Phase 1Healthy volunteerpharmacokineticssafetytolerabilityMultiple ascending doses

Outcome Measures

Primary Outcomes (1)

  • Adverse Events, vital signs

    Day -1 until follow-up

Secondary Outcomes (3)

  • Maximum plasma concentration (Cmax)

    Day 1 - Day 12

  • Time to Cmax (tmax)

    Day 1 - Day 12

  • Terminal rate constant (λz)

    Day 1 - Day 12

Study Arms (2)

1

EXPERIMENTAL

AZD2516 (dose escalating)

Drug: AZD2516

2

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

AZD2516DRUG

Oral, single, daily, 11 days

1
PlaceboDRUG
2

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

London, United Kingdom

Location

Study Officials

  • Darren Wilbraham, MBBS, DCPSA

    Quintiles Drug Research Unit 6, Newcomen Street, London, SE1 1YR

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 18, 2010

First Posted

June 22, 2010

Study Start

June 1, 2010

Primary Completion

July 1, 2010

Study Completion

July 1, 2010

Last Updated

February 8, 2011

Record last verified: 2011-02

Locations

GB(1)