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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
History of Changes
  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:

U.S. FDA Resources

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 May 19, 2013