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CompletedPhase 1

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

Asset

TRx0037

Listed sites

0

Recruiting sites

-

Enrollment

31

actual

Study population

Alzheimer’s disease

Key I/E criterion

•Age ≥55

Primary endpoints

•Bioavailability•Pharmacokinetics•Safety and tolerability

Identifiers

Registered as

NCT IDNCT01253499
Org study IDTRx-037-003

Timeline

Milestones

Study start2010-03 (month precision)
Primary completion2010-05actual (month precision)
Study completion2010-05actual (month precision)
Study first posted2010-12-03estimated
Last update posted2010-12-17estimated

Assets

Drug assets

TRx0037

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age55 Years
SexAll
Healthy volunteersAccepted

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

Endpoints (3)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK
2
Other (unclassified)
1

Safety / tolerability / PK

2 endpoints
Primary/protocol endpoint

Pharmacokinetics

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

descriptive

Primary/protocol endpoint

Safety and tolerability

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

event count, event

Other (unclassified)

1 endpoint
Primary/protocol endpoint/low confidence

Bioavailability

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

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.