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Comparative Bioavailability in Healthy Elderly Volunteers

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01253122
First Posted: December 3, 2010
Last Update Posted: December 3, 2010
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.
Collaborator:
Quotient Clinical
Information provided by:
TauRx Therapeutics Ltd
December 2, 2010
December 3, 2010
December 3, 2010
February 2010
April 2010   (Final data collection date for primary outcome measure)
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
Same as current
No Changes Posted
Safety, tolerability and pharmacokinetics
Safety, tolerability and pharmacokinetic (PK) evaluations of the two dose levels of TRx0037 and TRx0014.
Same as current
Not Provided
Not Provided
 
Comparative Bioavailability in Healthy Elderly Volunteers
Comparative Bioavailability of TRx0037 and TRx0014 in Healthy Elderly Volunteers
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Alzheimer's Disease
Drug: TRx0037
  • Experimental: TRx0037
    Intervention: Drug: TRx0037
  • Active Comparator: TRx0014
    Intervention: Drug: TRx0037
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
April 2010
April 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
55 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT01253122
TRx-037-002
No
Not Provided
Not Provided
Professor Claude M. Wischik, Chairman, TauRx Therapeutics Ltd
TauRx Therapeutics Ltd
Quotient Clinical
Principal Investigator: Stuart Dr Mair, MBChB Quotient Clinical
TauRx Therapeutics Ltd
December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP