Urinary Excretion of Acetylamantadine by Cancer Patients
1 other identifier
interventional
150
1 country
1
Brief Summary
The investigators have determined that the drug amantadine hydrochloride is metabolized by acetylation by a specific enzyme named spermidine/spermine N-acetyltransferase (SSAT). This enzyme is increased in cancer cells. The investigators hypothesized that the amount of N-acetylamantadine excreted in urine during the first 12 hours after an oral dose would serve as a diagnostic biomarker for the presence of cancer in a human test subject.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 cancer
Started Dec 2003
Typical duration for phase_2 cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2008
CompletedFirst Submitted
Initial submission to the registry
September 18, 2008
CompletedFirst Posted
Study publicly available on registry
September 19, 2008
CompletedNovember 30, 2023
November 1, 2023
4.5 years
September 18, 2008
November 27, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Amount of N-acetylamantadine excreted in a 12 hour urine sample collected after a single oral dose of amantadine hydrochloride ingested two hours after supper
12 hours
Study Arms (2)
1
ACTIVE COMPARATORPatients with a medical diagnosis of cancer appearing at outpatient clinics for treatment and/or monitoring of their disease status
2
ACTIVE COMPARATORHealthy adult volunteers
Interventions
Volunteer cancer patients ingest 2 x 100 mg tablets of amantadine hydrochloride with a glass of cold water 2 hours after supper.
Eligibility Criteria
You may qualify if:
- Either a medical diagnosis of cancer, or determination of general good health after a medical check-up within two weeks of participation in the study
You may not qualify if:
- Allergy to amantadine hydrochloride
- Chronic liver or kidney disease
- Chronic disease state not controlled by drug therapy, e.g. hypertension
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Manitobalead
- Canadian Institutes of Health Research (CIHR)collaborator
- BioMark Technologies Inc.collaborator
Study Sites (1)
University of Manitoba
Winnipeg, Manitoba, R3E 0W3, Canada
Related Publications (2)
Bras AP, Janne J, Porter CW, Sitar DS. Spermidine/spermine n(1)-acetyltransferase catalyzes amantadine acetylation. Drug Metab Dispos. 2001 May;29(5):676-80.
PMID: 11302933BACKGROUNDBras AP, Hoff HR, Aoki FY, Sitar DS. Amantadine acetylation may be effected by acetyltransferases other than NAT1 or NAT2. Can J Physiol Pharmacol. 1998 Jul-Aug;76(7-8):701-6. doi: 10.1139/cjpp-76-7-8-701.
PMID: 10030449BACKGROUND
MeSH Terms
Conditions
Study Officials
- PRINCIPAL INVESTIGATOR
Daniel S Sitar, PhD
University of Manitoba
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor Emeritus
Study Record Dates
First Submitted
September 18, 2008
First Posted
September 19, 2008
Study Start
December 1, 2003
Primary Completion
June 1, 2008
Study Completion
July 1, 2008
Last Updated
November 30, 2023
Record last verified: 2023-11