UMIN-CTR Clinical Trial

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

Healthy volunteers

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

Email

fumiko@hiroshima-u.ac.jp

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

Email

fumiko@hiroshima-u.ac.jp

Institute

Hiroshima University

Institute

Department

Personal name

Organization

SBI Pharmaceuticals Co., Ltd., Japan

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

広島大学病院（広島県）

Date of disclosure of the study information

2015

Year

10

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related 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