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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01253499

Enrollment

Registered

2010-12-03

Start date

2010-03-31

Completion date

2010-05-31

Last updated

2010-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer's Disease

Brief summary

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

Interventions

DRUGTRx0037

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

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

55 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026