Comparative Bioavailability in Healthy Elderly Volunteers
Primary Purpose
Alzheimer's Disease
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
TRx0037
Sponsored by
About this trial
This is an interventional basic science trial for Alzheimer's Disease
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
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
NCT ID
NCT01253122
First Posted
December 2, 2010
Last Updated
December 2, 2010
Sponsor
TauRx Therapeutics Ltd
Collaborators
Quotient Clinical
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
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Comparative Bioavailability in Healthy Elderly Volunteers
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