UMIN-CTR Clinical Trial

Basic information
Public title	Pharmacokinetics of orally-administered Nicotinamide Powder 10% Zonne and its NAD+ pathway metabolites
Acronym	Pharmacokinetics of vitamin B3 and NAD+ metabolites in blood and urine
Scientific Title	Pharmacokinetics of orally-administered Nicotinamide Powder 10% Zonne and its NAD+ pathway metabolites
Scientific Title:Acronym	Pharmacokinetics of vitamin B3 and NAD+ metabolites in blood and urine
Region	Japan

Condition
Condition	Not applicable
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To measure the concentration of nicotinamide and NAD+ pathway metabolites after oral administration of Nicotineamide Powder 10% Zonne
Basic objectives2	Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase I

Assessment
Primary outcomes	Pharmacokinetics of NAD+ in the blood and urine following the single administration of the drug
Key secondary outcomes	Pharmacokinetics of nicotinamide in the blood and urine following the single administration of the drug Safety evaluation with liver function monitoring

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Medicine
Interventions/Control_1	A single oral administration of Nicotinamide Powder 10% Zonne containing 200 mg of nicotinamide
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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	Those who agree to sign the informed consent form.
Key exclusion criteria	1. Those who take supplements containing vitamin B3 and wish to continue during the trial. 2. Those who are potentially pregnant. 3. Those who are under lactation. 4. Those who are under treatment. 5. Those judged by doctors or researchers to be inappropriate to participation in research.
Target sample size	8

Research contact person
Name of lead principal investigator	1st name Middle name Last name Mitsutoshi Setou
Organization	Hamamatsu University School of Medicine
Division name	Department of Cellular and Molecular Anatomy
Zip code
Address	1-20-1 Handayama, Higashi-ku, Hamamatsu, Shizuoka 431-3192 Japan
TEL	053-435-2086
Email	setou@hama-med.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Takashi Ito
Organization	Hamamatsu University School of Medicine
Division name	Department of Cellular and Molecular Anatomy
Zip code
Address	1-20-1 Handayama, Higashi-ku, Hamamatsu, Shizuoka 431-3192 Japan
TEL	053-435-2086
Homepage URL
Email	itotk777@hama-med.ac.jp

Sponsor
Institute	Hamamatsu University School of Medicine
Institute
Department

Funding Source
Organization	MEXT
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Other administrative information
Date of disclosure of the study information	2018 Year 03 Month 06 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	2018 Year 03 Month 01 Day
Date of IRB	2018 Year 01 Month 12 Day
Anticipated trial start date	2018 Year 03 Month 01 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 03 Month 06 Day
Last modified on	2019 Year 05 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036018

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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