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Completed

NCT Number: NCT01253499

Multiple Dose Study of TRx0037

The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of TRx0037 after multiple doses in elderly volunteers.

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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
  • Presence 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

75mg and 100mg tablets used to create doses of 100mg and 175mg. Active placebo 2mg and blank placebo used as comparators.

Primary outcomes

  1. Bioavailability

    Time frame: 19 Days (7-10 day follow up)

    The bioavailability of TRx0037 in an older population closer to the typical age range of the target patient population.

  2. Pharmacokinetics

    Time frame: 19 Days (7-10 day follow up)

    The pharmacokinetics for single doses of TRx0037 in healthy elderly volunteers.

  3. Safety and tolerability

    Time frame: 19 Days (7-10 day follow up)

    Safety and tolerability measurements including adverse events, physical examination findings, vital signs, ECG, and clinical laboratory measurements for single doses of TRx0037

Sponsors and collaborators

Lead sponsor

TauRx Therapeutics Ltd

Industry

Collaborators

  • Quotient Clinical

Registry information

Official study title

A Phase 1 Study Consisting of a Double-Blind, Placebo Controlled Multiple Dose Study of TRx0037 in Healthy Elderly Volunteers

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Dec 3, 2010
Registry last updated
Dec 17, 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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