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Comparative Bioavailability in Healthy Elderly Volunteers

Primary Purpose

Alzheimer's Disease

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
TRx0037
Sponsored by
TauRx Therapeutics Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Alzheimer's Disease

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    TRx0037

    TRx0014

    Arm Description

    Outcomes

    Primary Outcome Measures

    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 Outcome Measures

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

    Full Information

    First Posted
    December 2, 2010
    Last Updated
    December 2, 2010
    Sponsor
    TauRx Therapeutics Ltd
    Collaborators
    Quotient Clinical
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01253122
    Brief Title
    Comparative Bioavailability in Healthy Elderly Volunteers
    Official Title
    Comparative Bioavailability of TRx0037 and TRx0014 in Healthy Elderly Volunteers
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2010
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2010 (undefined)
    Primary Completion Date
    April 2010 (Actual)
    Study Completion Date
    April 2010 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    TauRx Therapeutics Ltd
    Collaborators
    Quotient Clinical

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Alzheimer's Disease

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Phase 1
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    24 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    TRx0037
    Arm Type
    Experimental
    Arm Title
    TRx0014
    Arm Type
    Active Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    TRx0037
    Primary Outcome Measure Information:
    Title
    Relative bioavailability
    Description
    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 Measure Information:
    Title
    Safety, tolerability and pharmacokinetics
    Description
    Safety, tolerability and pharmacokinetic (PK) evaluations of the two dose levels of TRx0037 and TRx0014.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Stuart Dr Mair, MBChB
    Organizational Affiliation
    Quotient Clinical
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Comparative Bioavailability in Healthy Elderly Volunteers

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