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

• Healthy

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