Urinary Excretion of Acetylamantadine by Normal Healthy Volunteers
1 other identifier
interventional
20
1 country
1
Brief Summary
Amantadine appears to be a specific substrate for acetylation by spermidine/spermine N1-acetyltransferase (SSAT). SSAT activity in cancer cells is higher by several-fold compared to normal cells. Amantadine can be used to determine SSAT cellular activity, and may indicate the presence of cancer. This study will provide additional information in conjunction with data from a previous study which include cancer patients and normal health age matched controls to determine whether urinary excretion of acetylamantadine is predictive for the presence of cancer, and if so whether excretion of this metabolite is associated with any particular site of the tumor. Based on the results of the first study additional data in normal healthy volunteers is required. The data from both studies will be analyzed to account for subject gender, stage of disease at time of testing, concurrent diseases, alcohol and tobacco use and occupational characteristics. This is an important first step in validating a cancer detection method that can be implemented economically for screening of large numbers of people at sites remote from limited and expensive diagnostic instrumentation. Thus there is a possibility that this design can be prognosis biomarker as well as a positive/negative indicator.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2011
Shorter than P25 for not_applicable
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
First Submitted
Initial submission to the registry
October 31, 2011
CompletedStudy Start
First participant enrolled
November 1, 2011
CompletedFirst Posted
Study publicly available on registry
November 8, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2012
CompletedJuly 29, 2013
July 1, 2013
5 months
October 31, 2011
July 26, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Amount of N-acetylamantadine excreted in a 12 hour urine sample collected after a signle oral dose of amatadine hydrochloride ingested 2 hours before breakfast
12 hours after dosing
Study Arms (1)
Amantadine
EXPERIMENTALSingle dose
Interventions
Eligibility Criteria
You may qualify if:
- Normal Healthy Volunteers (20 female and 20 male)
- Ages 18-69
You may not qualify if:
- Previous adverse reaction of amantadine
- Pregnant or lactating females
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Manitobalead
- St. Boniface Hospitalcollaborator
Study Sites (1)
St. Boniface General Hospital
Winnipeg, Manitoba, R2H 2A6, Canada
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bram Ramjiawan, Ph.D.
St. Boniface Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 31, 2011
First Posted
November 8, 2011
Study Start
November 1, 2011
Primary Completion
April 1, 2012
Study Completion
April 1, 2012
Last Updated
July 29, 2013
Record last verified: 2013-07