Multiple Dose Study of TRx0037

TauRx Therapeutics Ltd31 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

TRIPLE

Enrollment

Conditions

Alzheimer's Disease

Interventions

TRx0037DRUG

75mg and 100mg tablets used to create doses of 100mg and 175mg. Active placebo 2mg and blank placebo used as comparators.

Eligibility

Sex: ALLMin age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Bioavailability

The bioavailability of TRx0037 in an older population closer to the typical age range of the target patient population.

Time frame: 19 Days (7-10 day follow up)

Pharmacokinetics

The pharmacokinetics for single doses of TRx0037 in healthy elderly volunteers.

Time frame: 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

Time frame: 19 Days (7-10 day follow up)

Data from ClinicalTrials.gov

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