Multiple Dose Study of TRx0037

A Phase 1 Study Consisting of a Double-Blind, Placebo Controlled Multiple Dose Study of TRx0037 in Healthy Elderly Volunteers

The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of TRx0037 after multiple doses in elderly volunteers.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 31
• 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
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Triple

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TRx0037; Double blind placebo controlled study of TRx0037 in healthy elderly volunteers to assess safety, tolerability, bioavailability and pharmacokinetics	Drug: TRx0037; 75mg and 100mg tablets used to create doses of 100mg and 175mg. Active placebo 2mg and blank placebo used as comparators.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bioavailability	The bioavailability of TRx0037 in an older population closer to the typical age range of the target patient population.	19 Days (7-10 day follow up)
Pharmacokinetics	The pharmacokinetics for single doses of TRx0037 in healthy elderly volunteers.	19 Days (7-10 day follow up)
Safety and tolerability	Safety and tolerability measurements including adverse events, physical examination findings, vital signs, ECG, and clinical laboratory measurements for single doses of TRx0037	19 Days (7-10 day follow up)

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: March 1, 2010
• Primary Completion (Actual): May 1, 2010
• Study Completion (Actual): May 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 17, 2010
• Last Update Submitted That Met QC Criteria: December 16, 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-037-003