UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031610
Receipt number R000036018
Scientific Title Pharmacokinetics of orally-administered Nicotinamide Powder 10% Zonne and its NAD+ pathway metabolites
Date of disclosure of the study information 2018/03/06
Last modified on 2019/05/22 21:01:37

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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 or person

Institute

Hamamatsu University School of Medicine

Institute

Department

Personal name



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

Value
https://center6.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