UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019168 |
|---|---|
| Receipt number | R000022164 |
| Scientific Title | Plasma and urinary concentrations of 5-aminolevulinic acid (5-ALA) and its metabolites after oral administration of 5-ALA hydrochloride in healthy subjects. |
| Date of disclosure of the study information | 2015/10/01 |
| Last modified on | 2018/04/05 09:51:51 |
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Basic information
Public title
Plasma and urinary concentrations of 5-aminolevulinic acid (5-ALA) and its metabolites after oral administration of 5-ALA hydrochloride in healthy subjects.
Acronym
Plasma and urinary concentrations of 5-aminolevulinic acid (5-ALA) and its metabolites after oral administration of 5-ALA hydrochloride in healthy subjects.
Scientific Title
Plasma and urinary concentrations of 5-aminolevulinic acid (5-ALA) and its metabolites after oral administration of 5-ALA hydrochloride in healthy subjects.
Scientific Title:Acronym
Plasma and urinary concentrations of 5-aminolevulinic acid (5-ALA) and its metabolites after oral administration of 5-ALA hydrochloride in healthy subjects.
Region
| Japan |
Condition
Condition
Healthy volunteers
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the plasma and urinary concentrations of 5-aminolevulinic acid (5-ALA) and its metabolites after oral administration of 5-ALA hydrochloride in healthy volunteers.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
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).
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Oral administration of 5-ALA hydrochloride; the 100-mg dose followed by 300-mg dose after not less than 2 days break.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 40 | years-old | <= |
Age-upper limit
| 79 | years-old | >= |
Gender
Male and Female
Key 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.
Key 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)
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Fumiko Higashikawa |
Organization
Hiroshima University, Institute of Biomedical & Health Sciences
Division name
Project Research Center for Clinical Trial and Preventive Medicine
Zip code
Address
Kasumi 1-2-3, Minami-ku, Hiroshima 734-8551, JAPAN
TEL
082-257-1533
fumiko@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Fumiko Higashikawa |
Organization
Hiroshima University, Institute of Biomedical & Health Sciences
Division name
Project Research Center for Clinical Trial and Preventive Medicine
Zip code
Address
Kasumi 1-2-3, Minami-ku, Hiroshima 734-8551, JAPAN
TEL
082-257-1533
Homepage URL
fumiko@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
SBI Pharmaceuticals Co., Ltd., Japan
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
広島大学病院（広島県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 09 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 11 | Month | 02 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 09 | Month | 30 | Day |
Last modified on
| 2018 | Year | 04 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022164
