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

Sponsor

AstraZeneca (Industry)

Overall Status

Completed

CT.gov ID

NCT00914303

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

8.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: AZD3241 Drug: Placebo Tablet	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

77 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Basic Science

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

Study Start Date :

Jun 1, 2009

Actual Primary Completion Date :

Mar 1, 2010

Actual Study Completion Date :

Mar 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: AZD3241 AZD3241 Tablets	Drug: AZD3241 Oral Tablet, Repeated Administration
Experimental: Placebo Placebo Tablets	Drug: Placebo Tablet Oral Tablet. Repeated Administration

Arm

Intervention/Treatment

Experimental: AZD3241

AZD3241 Tablets

Drug: AZD3241

Oral Tablet, Repeated Administration

Experimental: Placebo

Placebo Tablets

Drug: Placebo Tablet

Oral Tablet. Repeated Administration

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Site	Uppsala		Sweden

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director: Rolf Karlsten, MD, Medical Science Director AstraZeneca R&D Södertälje.
Principal Investigator: Wolfgang Kuhn, MD, PhD, Quintiles AB Phase I Unit, Uppsala, Sweden