Healthy volunteers
Conditions
Interventions
Oral administration of 5-ALA hydrochloride
the 100-mg dose followed by 300-mg dose after not less than 2 days break.
Sponsors
Hiroshima University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Healthy volunteers without a diagnosis of cancer confirmed by the following cancer screening tests within two years: gastric cancer (gastric X-ray or endoscopy), large-bowel cancer (test of stool for the presence of blood or large bowel endoscopy), and lung cancer (chest X-ray or helical CT) for both male and female; breast cancer (mammography or ultrasonic examination) and uterine cervix cancer for female.
Exclusion criteria
Exclusion criteria: 1) History of cancer diagnosis 2) Participation in any clinical trial within 90 days of the commencement of the trial 3) Pregnant or nursing a child 4) Cardiac, renal, and/or hepatic dysfunction 5) History of severe disease and/or major surgery 6) History of hypersensitivity caused by 5-aminolevulinic acid or porphyrin 7) Porphyria 8) Severe anemia 9) Taking drugs or functional food that may cause photosensitivity (e.g. tetracycline antibiotics, sulfonamides, new quinolone antibacterial agents, Hypericum perforatum, and so on)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma and urinary concentrations of 5-ALA and its metabolites at baseline, and at 4, 6, and 8 hours after oral administration of 5-ALA hydrochloride. Plasma: 5-ALA, uroporphyrin I/III, coproporphyrin I/III, and protoporphyrin IX. Urine (creatinine correction): 5-ALA, uroporphyrin I/III, coproporphyrin I/III (HPLC), and coproporphyrin I+III (fluorescence method). | — |
Countries
Japan
Contacts
Public ContactFumiko Higashikawa
Hiroshima University Hospital Medical Center for Translational and Clinical Research
Outcome results
None listed