- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00418002
Safety and Tolerability of AQW051 in Elderly Healthy Volunteers.
June 21, 2007 updated by: Novartis
A Randomized, Double-Blind, Ascending Dose, Placebo-Controlled Single Dose Study in Non-Smoking Healthy Elderly Subjects Interleaved With a 2-Week Multiple Once Daily Dose Study to Explore Safety, Tolerability, Pharmacokinetics and Cognitive Effects After Oral Administration of AQW051
The purpose of this study is to assess safety and tolerability of AQW051 administered in single and multiple doses to elderly healthy volunteers.
In addition, pharmacokinetic effects will be assessed and the possible effects on cognition.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
72
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Horsham, United Kingdom
- Novartis Investigative Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
58 years to 78 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy male and postmenopausal female subjects between 60 to 80 years of age and in good health as determined by past medical history.
- Postmenopausal women must have no regular menstrual bleeding for at least 1 year prior to inclusion.
- Male subjects must be using a double-barrier local contraception.
- Body mass index must be within the range of 18 to 33. Subjects must weigh at least 50 kg to participate in this study.
- The regular intake of concomitant drugs including thyroxine, paracetamol, low dose non-steroidal anti-inflammatory drugs, lipid lowering drugs, vitamins and dietary supplements without caffeine and nicotinic acid, and hormone replacement therapy is allowed, if on stable treatment for at least 3 months. Intake of nutritional supplements (e.g. omega-3, vitamins, minerals, cod-liver oil) is allowed.
- Able to communicate well with the investigator, to understand and comply with the requirements of the study. Understand and sign the written informed consent.
Exclusion Criteria:
- Smokers (use of tobacco products in the previous 3 months).
- Use of any prescription drugs within 4 weeks prior dosing, or over-the-counter medication (e.g. herbal supplements) within 2 weeks prior to study start except noted previously
- Use of any central nervous system active drug and anticholinergic drugs during the previous 3 months and use of any drug or treatment known to cause major organ system toxicity during the previous 3 months is prohibited.
- A past personal or close family medical history of clinically significant cardiac abnormalities.
- Current diagnosis of cardiac arrhythmia derived from ECG and/or Holter ECG.
- Current diagnosis of cardiovascular disease.
- Current diagnosis or history of autonomic dysfunction (e.g. history of fainting, orthostatic hypotension, sinus arrhythmia).
- History of Acute or chronic bronchospastic disease (including asthma and chronic obstructive pulmonary disease) Clinically significant drug allergy or history of atopic allergy (asthma, urticaria, eczematous dermatitis) Known hypersensitivity or severe adverse event to darifenacin or similar drugs Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of drugs or which may jeopardize participation in the study Immunodeficiency diseases, including a positive HIV (ELISA and Western blot) test result Positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result. Drug or alcohol abuse within the 12 months prior to dosing.
- Diagnosis of cognitive impairment (Mini Mental State Exam < 27).
- History or current diagnosis of a cerebrovascular disease (e.g., stroke, transient ischemic attacks, aneurysms).
- Current DSM-IV diagnosis of major depression and/or any other DSM-IV Axis 1 diagnosis that may interfere with the evaluation of the patient's response to study medication, including other primary neurodegenerative dementia, schizophrenia, or bipolar disorder.
- History or current diagnosis of an active, uncontrolled seizure disorder.
- History of head injury or any other neurological disorder.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Safety and tolerability.
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Secondary Outcome Measures
Outcome Measure |
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Pharmacokinetics at the end of the study.
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Effect of AQW051 on cognition as assessed by a computerized cognitive test battery.
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To assess a potential food effect on pharmacokinetics of AQW051.
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To explore the drug abuse liability potential of AQW051.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2006
Study Registration Dates
First Submitted
January 3, 2007
First Submitted That Met QC Criteria
January 3, 2007
First Posted (Estimate)
January 4, 2007
Study Record Updates
Last Update Posted (Estimate)
June 22, 2007
Last Update Submitted That Met QC Criteria
June 21, 2007
Last Verified
June 1, 2007
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- CAQW051A2102
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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