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NCT00914303 Clinical Trial

Study to Evaluate Different Extended Release (ER)-Formulations and Multiple Ascending Dosing of AZD3241

Healthy Clinical Trial

Official title:
A Phase I, Single Centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability and Pharmacokinetics of Extended Release Tablets of AZD3241 After Administration of Multiple Ascending Doses in Healthy Male and Female Volunteers Including Food Effect

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00914303
Other study ID # D0490C00002
Secondary ID EudraCT No 2007-
Status Completed
Phase Phase 1
First received June 1, 2009
Last updated April 5, 2010
Start date June 2009
Est. completion date March 2010

Study information
Verified date April 2010
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority Sweden: Medical Products Agency
Study type Interventional

Clinical Trial Summary

The aims of the study are to assess the safety, tolerability and pharmacokinetics of ER tablets of AZD3241 following multiple ascending doses administered to healthy male and female subjects including the effect of food.

Recruitment information / eligibility
Status Completed
Enrollment 77
Est. completion date March 2010
Est. primary completion date March 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 30 Years to 65 Years
Eligibility Inclusion Criteria:

- Healthy male and female subjects 30-65 years

- Body Mass Index (BMI) between 18 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg

Exclusion Criteria:

- History of any clinically significant disease or disorder

- History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs

- Previous history of frequent pre-syncope or syncope

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

Intervention

Drug:
• AZD3241
Oral Tablet, Repeated Administration
• Placebo Tablet
Oral Tablet. Repeated Administration

Locations
Country Name City State
Sweden Research Site Uppsala

Sponsors (1)
Lead Sponsor Collaborator
AstraZeneca

Country where clinical trial is conducted

Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary Safety variables (adverse events, vital signs, ECG, safety lab) Assessments performed at frequent timepoints during a 4-8 week period Yes
Secondary To characterize the pharmacokinetics of AZD3241 in plasma Frequent sampling occasions during some study days for a 4-8 weeks period No
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