Multiple Dose Study of TRx0037

Phase 1

Completed

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

• Registration Number: NCT01253499
• Lead Sponsor: TauRx Therapeutics Ltd

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03
• Primary Completion: 2010-05
• Study Completion: 2010-05
• Status Verified: 2010-12
• Study First Submitted: 2010-12-02
• Study First Submitted QC: 2010-12-02
• Study First Posted: 2010-12-03
• Last Update Submitted: 2010-12-16
• Last Update Posted: 2010-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TRx0037	TRx0037	Double blind placebo controlled study of TRx0037 in healthy elderly volunteers to assess safety, tolerability, bioavailability and pharmacokinetics

Primary Outcome Measures

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