To investigate the safety, tolerability and pharmacokinetics of AZD2516 after multiple dosing in healthy volunteers
Study identifier:D2080C00002
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
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
Medical condition
Part A Healthy young males and non-fertile female volunteers aged 20 to 45 years.
Phase
Phase 1
Healthy volunteers
Yes
Study drug
AZD2516, Placebo
Sex
All
Actual Enrollment
6
Study type
Interventional
Age
20 Years - 80 Years
Date
Study Start Date: 01 Jun 2010
Primary Completion Date: 01 Jul 2010
Study Completion Date: 01 Jul 2010
Study design
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verification:
Verified 01 Nov 2013 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
Quintiles
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 AZD2516 (dose escalating) | Drug: AZD2516 Oral, single, daily, 11 days |
| Placebo Comparator: 2 Placebo | - |
Contacts
Investigators
Principal Investigator
Darren Wilbraham
Quintiles Drug Research Unit 6, Newcomen Street, London, SE1 1YR
