Comparative Bioavailability in Healthy Elderly Volunteers

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. Identifier: NCT01253122
Recruitment Status : Completed
First Posted : December 3, 2010
Last Update Posted : December 3, 2010
Quotient Clinical
Information provided by:
TauRx Therapeutics Ltd

Brief Summary:
A randomised four way crossover design in which each subject will receive two dose levels of TRx-0037 and two doses of TRx-0014 over approximately a four week period in randomised order.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Drug: TRx0037 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Comparative Bioavailability of TRx0037 and TRx0014 in Healthy Elderly Volunteers
Study Start Date : February 2010
Actual Primary Completion Date : April 2010
Actual Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: TRx0037 Drug: TRx0037
Active Comparator: TRx0014 Drug: TRx0037

Primary Outcome Measures :
  1. Relative bioavailability
    Investigate the relative bioavailability of TRx0037 and TRx0014 at two molar equivalent doses in healthy elderly male and female (post-menopausal/non-childbearing) subjects

Secondary Outcome Measures :
  1. Safety, tolerability and pharmacokinetics
    Safety, tolerability and pharmacokinetic (PK) evaluations of the two dose levels of TRx0037 and TRx0014.

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Male and female 55 and over
  • No clinically important abnormal physical finding
  • No clinically significant lab results
  • Normal ECG, Normal BP and HR,BMI between 19 and 32
  • Weight 50 to 100 kg, Able to communicate
  • Provide written informed consent
  • Non smokers
  • Males to use contraception
  • Females to be surgically sterile or post menopausal

Exclusion Criteria:

  • Administration of any IMP other than study drug within 12 weeks before entry
  • Use of any prescribed meds, St John's wort, over the counter meds as described in the protocol
  • Surgical or medical condition that might interfere with IMP
  • History of drug or alcohol abuse
  • Clinically significant allergy requiring treatment
  • Loss of greater than 400ml of blood within 12 weeks.
  • Serious adverse reaction or hypersensitivity to any drug
  • Prescence of Hep B, Hep c or HIV-1 or HIV-2 at screening
  • Presence of G6PD at screening
  • History of methaemoglobinaemia
  • Partner who is pregnant of lactating
  • Positive Pregnancy test

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 identifier (NCT number): NCT01253122

Sponsors and Collaborators
TauRx Therapeutics Ltd
Quotient Clinical
Principal Investigator: Stuart Dr Mair, MBChB Quotient Clinical

Responsible Party: Professor Claude M. Wischik, Chairman, TauRx Therapeutics Ltd Identifier: NCT01253122     History of Changes
Other Study ID Numbers: TRx-037-002
First Posted: December 3, 2010    Key Record Dates
Last Update Posted: December 3, 2010
Last Verified: December 2010

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders