UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000019189
Receipt number R000022180
Scientific Title A Multicenter, placebo-controlled single blind, dose-escalation, Investigator initiated trial for seven days repeated intravenous administration of NK-104-NP to healthy adult male volunteers for seven days
Date of disclosure of the study information 2015/10/01
Last modified on 2016/04/04 09:14:12

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Basic information

Public title

A Multicenter, placebo-controlled single blind, dose-escalation, Investigator initiated trial for seven days repeated intravenous administration of NK-104-NP to healthy adult male volunteers for seven days

Acronym

Repeated Intravenous Administration of NK-104-NP to healthy volunteers for seven days

Scientific Title

A Multicenter, placebo-controlled single blind, dose-escalation, Investigator initiated trial for seven days repeated intravenous administration of NK-104-NP to healthy adult male volunteers for seven days

Scientific Title:Acronym

Repeated Intravenous Administration of NK-104-NP to healthy volunteers for seven days

Region

Japan


Condition

Condition

Pulmonary Hypertension

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

In order to clarify the safety for repeated intravenous administration of NK-104-NP containing 2,4,8 mg of pitavastatin calcium to adult male healthy volunteers for seven days, as well as to evaluated pharmacokinetics for the parent compound in plasma and urine.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Safety: Names, severity and frequency of adverse effect and adverse drug reactions.
Pharmacokinetics: Concentrations of pitavastatin and pitavastatin lactone

Key secondary outcomes

Change of physiological functions (body temparature, blood pressure, plus SPO2),change of laboratory evidences, change of a chest X-ray examination and change of cardiac functions.


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

NK-104-NP 2 mg/body

Interventions/Control_2

NK-104-NP 4 mg/body

Interventions/Control_3

NK-104-NP 8 mg/body

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

40 years-old >=

Gender

Male

Key inclusion criteria

1)Healthy Male Japanese
2)A person aged 20yo to 40yo
3)A person with a BMI values under 18.5 or over 30.0

Key exclusion criteria

1)A person who has history of drug allergy.
2)A person who has hypersensitivity including allergy (except asymptomatic allergy).
3)A person who used other therapeutic drugs within 2 weeks or who needs other therapeutic drugs during the clinical trial participation period.
4)A person who used other OTC drugs within a week or who needs other OTC drugs during the clinical trial participation period.
5)A person who donated over 200 mL of whole blood within a month, who experienced plasmapheresis/platelet apheresis within 2 weeks or who donated over 400 mL of whole blood within 3 months.
6)A person who was given new drugs in other clinical trials within four months before this clinical trial or a person who participates in other clinical trials at the same time with this clinical trial.
7)A person whose percutaneous arterial oxygen saturation is less than 95%.
8)A person with alcohol or drug dependence.
9)A person who is positive for drug abuse testing.
10)A person who is positive for the following tests: HBs antigen, HCV antibody, HIV antigen/antibody or syphilis serum reaction.
11)A person who cannot prevent pregnancy during 6 months after this clinical trial.
12)A person assessed as ineligible for enrollment by investigators of this clinical trial.
13)A person who was administrated NK-104-NP in the past

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Tetsuya Matoba

Organization

Kyushu University Hospital

Division name

Department of Cardovascular Medicine

Zip code


Address

3-1-1 Maidashi, Higashi-ku,Fukuoka

TEL

092-642-6919

Email

matoba@cardiol.med.kyushu-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kaku Nakano

Organization

Kyushu University

Division name

Department of Cardiovascular Research, Development, and Translational Medicine

Zip code


Address

3-1-1 Maidashi, Higashi-ku,Fukuoka

TEL

092-642-6919

Homepage URL


Email

kaku@cardiol.med.kyushu-u.ac.jp


Sponsor or person

Institute

Kyushu University Hospital

Institute

Department

Personal name



Funding Source

Organization

Japan Agency for Medical Research and Development (AMED)

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization



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

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 07 Month 17 Day

Date of IRB


Anticipated trial start date

2015 Year 10 Month 19 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 10 Month 01 Day

Last modified on

2016 Year 04 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022180


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name