Comparative Bioavailability in Healthy Elderly Volunteers

TauRx Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Alzheimer's Disease

Treatments: Drug: TRx0037

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01253122

TRx-037-002

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 55+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

TRx0037

Experimental group

Treatment:

Drug: TRx0037

TRx0014

Active Comparator group

Treatment:

Drug: TRx0037