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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: AZD3241; Drug: Placebo Tablet

• Registration Number: NCT00914303
• Lead Sponsor: AstraZeneca

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2009-06-01
• Study First Submitted QC: 2009-06-03
• Study First Posted: 2009-06-04
• Primary Completion: 2010-03
• Study Completion: 2010-03
• Status Verified: 2010-04
• Last Update Submitted: 2010-04-05
• Last Update Posted: 2010-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 77

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AZD3241	AZD3241	AZD3241 Tablets
Placebo	Placebo Tablet	Placebo Tablets

Primary Outcome Measures

Name	Time	Method
Safety variables (adverse events, vital signs, ECG, safety lab)	Assessments performed at frequent timepoints during a 4-8 week period

Secondary Outcome Measures

Name	Time	Method
To characterize the pharmacokinetics of AZD3241 in plasma	Frequent sampling occasions during some study days for a 4-8 weeks period

Trial Locations

Locations (1)

Research Site; 🇸🇪 Uppsala, Sweden