Safety, Tolerability, and Pharmacokinetics of NK-104-NP A Multicenter, Randomized, Placebo-Controlled Phase I Investigator-Initiated Trial for Intravenous Administration of Pitavastatin-Loaded PLGA Nanoparticles (NK-104-NP) in Healthy Japanese Male Subjects

• Published in: International Heart Journal Vol. 59; no. 5; pp. 1015 - 1025
• Main Authors: Nakano, Kaku, Matoba, Tetsuya, Koga, Jun-ichiro, Kashihara, Yushi, Fukae, Masato, Ieiri, Ichiro, Shiramoto, Masanari, Irie, Shin, Kishimoto, Junji, Todaka, Koji, Egashira, Kensuke
• Format: Journal Article
• Language: English
• Published: Tokyo International Heart Journal Association 01.09.2018; Japan Science and Technology Agency
• Subjects: Calcium; Clinical trials; Drug delivery; Drug delivery system; Drug dosages; Glycolic acid; Inflammation; Intravenous administration; Medical innovations; Nanoparticles; Nanotechnology; Pharmacokinetics; Phase I clinical trial; Population pharmacokinetic analysis; Pulmonary arteries; Pulmonary artery; Pulmonary hypertension; Statin; Stenosis

Pulmonary hypertension (PH) is a disease with poor prognosis, caused by the obstruction/stenosis of small pulmonary arteries. Statin is known to have vasodilating and anti-inflammatory property and is considered to be a candidate of therapeutic agents for the treatment of PH, but its efficacy has no...