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

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

Collaborators

Inclusion and exclusion criteria

Location

Research site

London, United Kingdom

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

"There is no result for the study"

Documents available

Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information

800-236-9933

information.center@astrazeneca.com

Contact Backup

Partheeban Senthilnathan

+44 (0) 2079107884

Partheeban.Senthilnathan@quintiles.com

Investigators

Principal Investigator

Darren Wilbraham

Quintiles drug research unit, 6 Newcomen Street, SE1 1YR