UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Safety trial of oral coadministration of 5-aminolevulinic acid phosphate with sodium ferrous citrate to healthy subjects
Title of the study (Brief title)	Safety trial of oral coadministration of 5-aminolevulinic acid phosphate with sodium ferrous citrate to 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 safety of oral coadministration of 5-aminolevulinic acid phosphate (250 mg/day) with sodium ferrous citrate (143.4 mg/day).
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Adverse event including laboratory abnormality and the change of CTCAE grade
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	Food
Interventions/Control_1	Subjects receive 250 mg/day of 5-aminolevulinic acid phosphate and 143.4 mg/day of sodium ferrous citrate (15 mg as Fe) for 28 days.
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	20 years-old <=
Age-upper limit	59 years-old >=
Gender	Male and Female
Key inclusion criteria	Healthy
Key exclusion criteria	1) Taking medicines for chronic disease 2) Taking functional food that may affect the trial 3) Participation in any clinical trial within 90 days of the commencement of the trial 4) In pregnancy or nursing a child 5) History of severe disease and/or major surgery 6) History of hypersensitivity caused by 5-aminolevulinic acid or porphyrin 7) Subject or family history of diagnosis of porphyria 8) Severe anemia (Hemoglobin < 10 g/dL) 9) Judged as ineligible by clinical investigators
Target sample size	22

Research contact person
Name of lead principal investigator	Fumiko Higashikawa
Organization	Hiroshima University, Institute of Biomedical & Health Sciences
Division name	Project Research Center for Clinical Trial and Preventive Medicine
Address	Kasumi 1-2-3, Minami-ku, Hiroshima 734-8551, JAPAN
TEL	082-257-1533
Email	fumiko@hiroshima-u.ac.jp

Public contact
Name of contact person	Fumiko Higashikawa
Organization	Hiroshima University, Institute of Biomedical & Health Sciences
Division name	Project Research Center for Clinical Trial and Preventive Medicine
Address	Kasumi 1-2-3, Minami-ku, Hiroshima 734-8551, JAPAN
TEL	082-257-1533
Homepage URL
Email	fumiko@hiroshima-u.ac.jp

Sponsor
Institute	Hiroshima University
Institute
Department

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)

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	2016 Year 06 Month 22 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 06 Month 21 Day
Anticipated trial start date	2016 Year 08 Month 25 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 06 Month 21 Day
Last modified on	2017 Year 06 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000026309