Status:
COMPLETED
Multiple Dose Study of TRx0037
Lead Sponsor:
TauRx Therapeutics Ltd
Collaborating Sponsors:
Quotient Clinical
Conditions:
Alzheimer's Disease
Eligibility:
All Genders
55+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of TRx0037 after multiple doses in elderly volunteers.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT01253499
Start Date
March 1 2010
End Date
May 1 2010
Last Update
December 17 2010
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