Trial record 3 of 11 for:    TauRx

Multiple Dose Study of TRx0037

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01253499
Recruitment Status : Completed
First Posted : December 3, 2010
Last Update Posted : December 17, 2010
Quotient Clinical
Information provided by:
TauRx Therapeutics Ltd

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

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Drug: TRx0037 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: A Phase 1 Study Consisting of a Double-Blind, Placebo Controlled Multiple Dose Study of TRx0037 in Healthy Elderly Volunteers
Study Start Date : March 2010
Actual Primary Completion Date : May 2010
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: TRx0037
Double blind placebo controlled study of TRx0037 in healthy elderly volunteers to assess safety, tolerability, bioavailability and pharmacokinetics
Drug: TRx0037
75mg and 100mg tablets used to create doses of 100mg and 175mg. Active placebo 2mg and blank placebo used as comparators.

Primary Outcome Measures :
  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

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01253499

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

Responsible Party: Professor Claude M. Wischik, Chairman, TauRx Therapeutics Ltd Identifier: NCT01253499     History of Changes
Other Study ID Numbers: TRx-037-003
First Posted: December 3, 2010    Key Record Dates
Last Update Posted: December 17, 2010
Last Verified: December 2010

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders