Comparative Bioavailability in Healthy Elderly Volunteers

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

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 Intervention Phase
Alzheimer's Disease
Drug: TRx0037
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Comparative Bioavailability of TRx0037 and TRx0014 in Healthy Elderly Volunteers

Resource links provided by NLM:

Further study details as provided by TauRx Therapeutics Ltd:

Primary Outcome Measures:
  • 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

Secondary Outcome Measures:
  • Safety, tolerability and pharmacokinetics [ Designated as safety issue: Yes ]
    Safety, tolerability and pharmacokinetic (PK) evaluations of the two dose levels of TRx0037 and TRx0014.

Enrollment: 24
Study Start Date: February 2010
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TRx0037 Drug: TRx0037
Active Comparator: TRx0014 Drug: TRx0037


Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its identifier: NCT01253122

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

No publications provided

Responsible Party: Professor Claude M. Wischik, Chairman, TauRx Therapeutics Ltd Identifier: NCT01253122     History of Changes
Other Study ID Numbers: TRx-037-002
Study First Received: December 2, 2010
Last Updated: December 2, 2010
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders processed this record on April 16, 2014