Comparative Bioavailability in Healthy Elderly Volunteers

Phase 1

Completed

• Conditions: Alzheimer's Disease
• Interventions: Drug: TRx0037

• Registration Number: NCT01253122
• Lead Sponsor: TauRx Therapeutics Ltd

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02
• Primary Completion: 2010-04
• Study Completion: 2010-04
• Status Verified: 2010-12
• Study First Submitted: 2010-12-02
• Study First Submitted QC: 2010-12-02
• Last Update Submitted: 2010-12-02
• Study First Posted: 2010-12-03
• Last Update Posted: 2010-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
TRx0037	TRx0037	-
TRx0014	TRx0037	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Safety, tolerability and pharmacokinetics		Safety, tolerability and pharmacokinetic (PK) evaluations of the two dose levels of TRx0037 and TRx0014.