A Randomized, Single‐Center, Double‐Blind, Placebo‐Controlled Multiple‐Dose Phase 1 Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Imarikiren in Healthy Adult Nonelderly and Elderly Male Subjects

@article{Matsuno2018ARS,
  title={A Randomized, Single‐Center, Double‐Blind, Placebo‐Controlled Multiple‐Dose Phase 1 Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Imarikiren in Healthy Adult Nonelderly and Elderly Male Subjects},
  author={Kumi Matsuno and Shingo Tanaka and T. Hashimoto and Hiroyuki Nakamichi and Tomoya Kagawa and Emiko Koumura},
  journal={Journal of Clinical Pharmacology},
  year={2018},
  volume={58},
  pages={1516 - 1524}
}
Imarikiren hydrochloride (TAK‐272/ SCO‐272) is a novel direct renin inhibitor. This randomized, double‐blind, phase I study evaluated the safety and pharmacokinetics/pharmacodynamics of multiple oral administrations of imarikiren in healthy nonelderly (aged 20‐45 years) and elderly (aged 65‐85 years) Japanese male subjects. Subjects were randomized within 1 of 3 cohorts to receive imarikiren or placebo: Cohort 1 (imarikiren 80 mg; nonelderly), Cohort 2 (imarikiren 160 mg; nonelderly), or Cohort… Expand
4 Citations
Pharmacokinetics, Pharmacodynamics and Safety of a Single Dose of Imarikiren, a Novel Renin Inhibitor, in Healthy Male Subjects
TLDR
Plasma active renin concentration increased, reaching a maximum at approximately 6 hr, in a nearly dose‐dependent manner, and there was a generally linear relationship between dose and area under the plasma concentration–time curve (0 to infinity) or maximum plasma concentration of imarikiren. Expand
Efficacy and Safety of Imarikiren in Patients with Type 2 Diabetes and Microalbuminuria: A Randomized, Controlled Trial.
TLDR
Imarikiren resulted in a dose-dependent improvement in albuminuria compared with placebo, and it was well tolerated in patients with type 2 diabetes mellitus and microalbuminuria. Expand
Pharmacokinetics and Safety After a Single Dose of Imarikiren in Subjects with Renal or Hepatic Impairment
TLDR
RI and HI are associated with limited changes in imarikiren pharmacokinetics and Imarikirens was safe and well-tolerated, regardless of the severity of RI or HI. Expand
Efficacy and Safety of Imarikiren in Patients with Type 2 Diabetes and Microalbuminuria
Background and objectives Imarikiren is a novel, potent, and selective direct renin inhibitor that has shown high oral availability during clinical development for the treatment of diabeticExpand

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