Clinical trial · Interventional
Urinary Excretion of Acetylamantadine by Cancer Patients
NCT00755898CI-TRIAL-00071852completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ingestion of a 200 mg dose of amantadine hydrochloride | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- 1
- description
- Patients with a medical diagnosis of cancer appearing at outpatient clinics for treatment and/or monitoring of their disease status
- interventionNames
- Drug: Ingestion of a 200 mg dose of amantadine hydrochloride
- type
- ACTIVE_COMPARATOR
- label
- 2
- description
- Healthy adult volunteers
- interventionNames
- Drug: Ingestion of a 200 mg dose of amantadine hydrochloride
Primary outcomes (1)
- measure
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * Allergy to amantadine hydrochloride * Chronic liver or kidney disease * Chronic disease state not controlled by drug therapy, e.g. hypertension * Pregnancy
References
Publications (2)
- BACKGROUNDBras 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 11302933
- BACKGROUNDBras 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 10030449