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Completed

NCT Number: NCT01253122

Comparative Bioavailability 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.

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Key information

Conditions

Alzheimer's Disease Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TRx0037

Drug

Primary outcomes

  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 outcomes

  1. Safety, tolerability and pharmacokinetics

    Safety, tolerability and pharmacokinetic (PK) evaluations of the two dose levels of TRx0037 and TRx0014.

Sponsors and collaborators

Lead sponsor

TauRx Therapeutics Ltd

Industry

Collaborators

  • Quotient Clinical

Registry information

Official study title

Comparative Bioavailability of TRx0037 and TRx0014 in Healthy Elderly Volunteers

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Dec 3, 2010
Registry last updated
Dec 3, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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