Multiple Dose Study of TRx0037

This study has been completed.
Sponsor:
Collaborator:
Quotient Clinical
Information provided by:
TauRx Therapeutics Ltd
ClinicalTrials.gov Identifier:
NCT01253499
First received: December 2, 2010
Last updated: December 16, 2010
Last verified: December 2010
  Purpose

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


Condition Intervention Phase
Alzheimer's Disease
Drug: TRx0037
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by TauRx Therapeutics Ltd:

Primary Outcome Measures:
  • Bioavailability [ Time Frame: 19 Days (7-10 day follow up) ] [ Designated as safety issue: No ]
    The bioavailability of TRx0037 in an older population closer to the typical age range of the target patient population.

  • Pharmacokinetics [ Time Frame: 19 Days (7-10 day follow up) ] [ Designated as safety issue: No ]
    The pharmacokinetics for single doses of TRx0037 in healthy elderly volunteers.

  • Safety and tolerability [ Time Frame: 19 Days (7-10 day follow up) ] [ Designated as safety issue: Yes ]
    Safety and tolerability measurements including adverse events, physical examination findings, vital signs, ECG, and clinical laboratory measurements for single doses of TRx0037


Enrollment: 31
Study Start Date: March 2010
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  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
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01253499

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: NCT01253499     History of Changes
Other Study ID Numbers: TRx-037-003
Study First Received: December 2, 2010
Last Updated: December 16, 2010
Health Authority: United Kingdom: Research Ethics Committee
United States: Food and Drug Administration

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 April 15, 2014