Safety and Tolerability of AQW051 in Elderly Healthy Volunteers.

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00418002
First received: January 3, 2007
Last updated: June 21, 2007
Last verified: June 2007
  Purpose

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.


Condition Intervention Phase
Healthy
Drug: AQW051
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: 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

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Safety and tolerability.

Secondary Outcome Measures:
  • Pharmacokinetics at the end of the study.
  • Effect of AQW051 on cognition as assessed by a computerized cognitive test battery.
  • To assess a potential food effect on pharmacokinetics of AQW051.
  • To explore the drug abuse liability potential of AQW051.

Estimated Enrollment: 72
Study Start Date: May 2006
  Eligibility

Ages Eligible for Study:   60 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  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: NCT00418002

Locations
United Kingdom
Novartis Investigative Site
Horsham, United Kingdom
Sponsors and Collaborators
Novartis
Investigators
Principal Investigator: Novartis Investigator site
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00418002     History of Changes
Other Study ID Numbers: CAQW051A2102
Study First Received: January 3, 2007
Last Updated: June 21, 2007
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Novartis:
Single-rising dose , multiple rising dose, elderly, cognitive, , pharmacokinetic, impairment.
Healthy elderly male and female subjects

ClinicalTrials.gov processed this record on July 29, 2014