Status:
COMPLETED
To Assess the Effect of Administration of 2 Formulation of AZD3241 on Blood Concentration in Healthy Volunteers
Lead Sponsor:
AstraZeneca
Conditions:
Parkinson's Disease
Eligibility:
All Genders
30-65 years
Phase:
PHASE1
Brief Summary
To evaluate the pharmacokinetics of AZD3241 following multiple administration of 2 new, different extended release formulations of tablets of AZD3241 (300 mg), in relation to the 100 mg extended relea...
Detailed Description
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 T...
Eligibility Criteria
Inclusion
- Provision of signed and dated, written informed consent prior to any study specific procedures
- Healthy male or female volunteers aged 30 to 65 years, inclusive, with suitable veins for cannulation or repeated venepuncture
- Female volunteers must have a negative pregnancy test at Screening and on admission to the CPU, must not be lactating and must be of non childbearing potential, confirmed at Screening
- Male volunteers must be willing to use barrier contraception ie, condoms, from the first day of dose administration until 3 months after the last dose of the IP
- Volunteers must have a body mass index (BMI) between 18 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg
Exclusion
- History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the Investigator or history of hypersensitivity to drugs with a similar chemical structure or class to AZD3241
- Orthostatic hypotension defined as 25 mmHg decrease in systolic and/or 15 mmHg decrease in diastolic BP as measured at enrolment and/or randomisation
- History of intolerance or hypersensitivity to mannitol
- Prolonged QT interval corrected for heart rate using Fridericia's formula (QTcF)\>450 ms or shortened QTcF\<340 ms or a family history of long QT syndrome
- Abnormal vital signs, after 10 minutes of rest in supine position, defined as any of the following:Systolic BP\>140 mmHg., Diastolic BP\>90 mmHg., Heart rate\<40 or \>85 beats per minute.
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01457807
Start Date
November 1 2011
End Date
December 1 2011
Last Update
August 17 2012
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Research site
London, United Kingdom