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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000019189

Enrollment

Registered

2015-10-01

Start date

2015-10-19

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Hypertension

Interventions

NK-104-NP 2 mg/body NK-104-NP 4 mg/body NK-104-NP 8 mg/body

Eligibility

Sex/Gender

Male

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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.	—

Countries

Japan

Contacts

Public ContactKaku Nakano

Kyushu University Department of Cardiovascular Research, Development, and Translational Medicine

kaku@cardiol.med.kyushu-u.ac.jp092-642-6919

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026