Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
31 participants
INTERVENTIONAL
2010-03-31
2010-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
BASIC_SCIENCE
TRIPLE
Study Groups
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TRx0037
Double blind placebo controlled study of TRx0037 in healthy elderly volunteers to assess safety, tolerability, bioavailability and pharmacokinetics
TRx0037
75mg and 100mg tablets used to create doses of 100mg and 175mg. Active placebo 2mg and blank placebo used as comparators.
Interventions
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TRx0037
75mg and 100mg tablets used to create doses of 100mg and 175mg. Active placebo 2mg and blank placebo used as comparators.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
55 Years
ALL
Yes
Sponsors
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Quotient Clinical
OTHER
TauRx Therapeutics Ltd
INDUSTRY
Responsible Party
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TauRx Therapeutics Ltd
Principal Investigators
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Stuart Dr Mair, MBChB
Role: PRINCIPAL_INVESTIGATOR
Quotient Clinical
Other Identifiers
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TRx-037-003
Identifier Type: -
Identifier Source: org_study_id