Comparative Bioavailability in Healthy Elderly Volunteers

Comparative Bioavailability of TRx0037 and TRx0014 in Healthy Elderly Volunteers

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.

Study Overview

• Status: Completed
• Conditions: Alzheimer's Disease
• Intervention / Treatment: Drug: TRx0037

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TRx0037	Drug: TRx0037
Active Comparator: TRx0014	Drug: TRx0037

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description
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

Outcome Measure	Measure Description
Safety, tolerability and pharmacokinetics	Safety, tolerability and pharmacokinetic (PK) evaluations of the two dose levels of TRx0037 and TRx0014.

Collaborators and Investigators

• Sponsor: TauRx Therapeutics Ltd
• Collaborators: Quotient Clinical
• Investigators: Principal Investigator: Stuart Dr Mair, MBChB, Quotient Clinical

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (Actual): April 1, 2010
• Study Completion (Actual): April 1, 2010

Study Registration Dates

• First Submitted: December 2, 2010
• First Submitted That Met QC Criteria: December 2, 2010
• First Posted (Estimate): December 3, 2010

Study Record Updates

• Last Update Posted (Estimate): December 3, 2010
• Last Update Submitted That Met QC Criteria: December 2, 2010
• Last Verified: December 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease
• Other Study ID Numbers: TRx-037-002