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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00914303
First received: June 1, 2009
Last updated: April 5, 2010
Last verified: April 2010
  Purpose

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 Intervention Phase
Healthy
Drug: AZD3241
Drug: Placebo Tablet
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Safety variables (adverse events, vital signs, ECG, safety lab) [ Time Frame: Assessments performed at frequent timepoints during a 4-8 week period ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To characterize the pharmacokinetics of AZD3241 in plasma [ Time Frame: Frequent sampling occasions during some study days for a 4-8 weeks period ] [ Designated as safety issue: No ]

Enrollment: 77
Study Start Date: June 2009
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AZD3241
AZD3241 Tablets
Drug: AZD3241
Oral Tablet, Repeated Administration
Experimental: Placebo
Placebo Tablets
Drug: Placebo Tablet
Oral Tablet. Repeated Administration

  Eligibility

Ages Eligible for Study:   30 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00914303

Locations
Sweden
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
  More Information

No publications provided

Responsible Party: Rolf Karlsten , MD, PhD, Medical Science Director, AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00914303     History of Changes
Other Study ID Numbers: D0490C00002, EudraCT No 2007-003145-33
Study First Received: June 1, 2009
Last Updated: April 5, 2010
Health Authority: Sweden: Medical Products Agency

Keywords provided by AstraZeneca:
Safety
tolerability
healthy
Healthy volunteer study

ClinicalTrials.gov processed this record on September 16, 2014