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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00914303
Recruitment Status : Completed
First Posted : June 4, 2009
Last Update Posted : April 6, 2010
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Healthy Drug: AZD3241 Drug: Placebo Tablet Phase 1

Study Type : Interventional  (Clinical Trial)
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 : June 2009
Primary Completion Date : March 2010
Study Completion Date : March 2010

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



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

Secondary Outcome Measures :
  1. To characterize the pharmacokinetics of AZD3241 in plasma [ Time Frame: Frequent sampling occasions during some study days for a 4-8 weeks period ]


Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: June 4, 2009    Key Record Dates
Last Update Posted: April 6, 2010
Last Verified: April 2010

Keywords provided by AstraZeneca:
Safety
tolerability
healthy
Healthy volunteer study