Trial record 2 of 8 for:    TauRx

Comparative Bioavailability in Healthy Elderly Volunteers

This study has been completed.
Sponsor:
Collaborator:
Quotient Clinical
Information provided by:
TauRx Therapeutics Ltd
ClinicalTrials.gov Identifier:
NCT01253122
First received: December 2, 2010
Last updated: NA
Last verified: December 2010
History: No changes posted

December 2, 2010
December 2, 2010
February 2010
April 2010   (final data collection date for primary outcome measure)
Relative bioavailability [ Designated as safety issue: No ]
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 [ Designated as safety issue: Yes ]
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
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: 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
Both
55 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01253122
TRx-037-002
No
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