To assess the Effect of administration of 2 formulation of AZD3241 on blood concentration in healthy volunteers
Study identifier:D0490C00003
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Phase I, Single-centre, Double-blind, Randomised, Placebo-controlled, Parallel Group Study to Assess the Pharmacokinetics, Safety and Tolerability of Two Different Extended Release Formulations of Tablets of AZD3241 (300 mg) after Administration of Multiple Doses in Healthy Male and Female Volunteers
Medical condition
Parkinson's disease
Phase
Phase 1
Healthy volunteers
Yes
Study drug
AZD3241 ER formulation 1, Placebo, AZD3241 Alternative titration scheme with formulation 1 or 2
Sex
All
Actual Enrollment
24
Study type
Interventional
Age
30 Years - 65 Years
Date
Study Start Date: 01 Nov 2011
Primary Completion Date: 01 Dec 2011
Study Completion Date: 01 Dec 2011
Study design
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Other
Verification:
Verified 01 Aug 2012 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
Loading...
No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 AZD3241 300mg extended release formulation 1 | Drug: AZD3241 ER formulation 1 Oral tablets, 100mg bd on Day 1 to Day 2, 200mg bd on Day3, 300mg bd on Day 4 to Day7 and 300mg Once daily on Day 8 with High Fat Breakfast Drug: AZD3241 Alternative titration scheme with formulation 1 or 2 50 mg oral dose bd on Day 1, 100 mg oral dose bd on Day 2 and 3, 200 mg oral dose bd on Day 4, 300 mg oral dose bd on Day 5 to 7 and 300 mg once in the morning on Day 8 Other Name: This titration scheme will only be used if ER formulations 1 or 2 are not well tolerated |
| Experimental: 2 AZD3241 300mg extended release formulation 2 | Drug: AZD3241 Alternative titration scheme with formulation 1 or 2 50 mg oral dose bd on Day 1, 100 mg oral dose bd on Day 2 and 3, 200 mg oral dose bd on Day 4, 300 mg oral dose bd on Day 5 to 7 and 300 mg once in the morning on Day 8 Other Name: This titration scheme will only be used if ER formulations 1 or 2 are not well tolerated |
| Placebo Comparator: 3 Placebo | Drug: Placebo Placebo will be administered with the same intervention scheme as intervention 1 and 2 |
Contacts
Investigators
Principal Investigator
Darren Wilbraham
Quintiles drug research unit, 6 Newcomen Street, SE1 1YR
