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
  Purpose

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

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
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: NCT01253122

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

No publications provided

Responsible Party: Professor Claude M. Wischik, Chairman, TauRx Therapeutics Ltd
ClinicalTrials.gov 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
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 01, 2014