Kenichi Furihata
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View article: Japanese Phase 1 Study for Global Development of Anti‐<scp>TL1A</scp> Antibody <scp>PF</scp>‐06480605: A Randomized, Placebo‐Controlled, Single‐Ascending Dose Study
Japanese Phase 1 Study for Global Development of Anti‐<span>TL1A</span> Antibody <span>PF</span>‐06480605: A Randomized, Placebo‐Controlled, Single‐Ascending Dose Study Open
PF‐06480605, a fully human IgG1 monoclonal antibody targeting tumor necrosis factor α‐like ligand 1A (TL1A), has demonstrated acceptable safety and the potential as an effective treatment for inflammatory bowel disease in phase 1/2a studie…
View article: Pharmacokinetic and Pharmacodynamic Properties of Once-Weekly Insulin Efsitora Alfa in Japanese Patients with Type 2 Diabetes
Pharmacokinetic and Pharmacodynamic Properties of Once-Weekly Insulin Efsitora Alfa in Japanese Patients with Type 2 Diabetes Open
ClinicalTrials.gov, NCT03603704; NCT04276428.
View article: Effects of Cimetidine and Dolutegravir on the Endogenous Drug–Drug Interaction Biomarkers for Organic Cation Transporter 2 and Multidrug and Toxin Extrusion Protein 1 in Healthy Volunteers
Effects of Cimetidine and Dolutegravir on the Endogenous Drug–Drug Interaction Biomarkers for Organic Cation Transporter 2 and Multidrug and Toxin Extrusion Protein 1 in Healthy Volunteers Open
This study was designed to assess the quantitative performance of endogenous drug–drug interaction (DDI) biomarkers ( N 1‐methylnicotinamide (1‐NMN), N 1‐methyladenosine (m 1 A), and creatinine) for the organic cation transporters, OCT2 an…
View article: A multi‐purpose Japanese phase I study in the global development of vupanorsen: Randomized, placebo‐controlled, single‐ascending dose study in adults
A multi‐purpose Japanese phase I study in the global development of vupanorsen: Randomized, placebo‐controlled, single‐ascending dose study in adults Open
Vupanorsen (PF‐07285557) is a second‐generation tri‐ N ‐acetyl galactosamine (GalNAc 3 )‐antisense oligonucleotide targeted to angiopoietin‐like 3 (ANGPTL3) mRNA, shown to reduce lipids and apolipoproteins in subjects with dyslipidemia. To…
View article: A phase 1 study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of danuglipron ( <scp>PF</scp> ‐06882961), an oral small‐molecule glucagon‐like peptide‐1 receptor agonist, in Japanese adults with type 2 diabetes mellitus
A phase 1 study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of danuglipron ( <span>PF</span> ‐06882961), an oral small‐molecule glucagon‐like peptide‐1 receptor agonist, in Japanese adults with type 2 diabetes mellitus Open
Aims This study investigated the safety, tolerability, pharmacokinetics and pharmacodynamics of danuglipron (PF‐06882961), which is a novel, oral small‐molecule glucagon‐like peptide‐1 receptor agonist, in Japanese participants with type 2…
View article: A phase I, randomized, placebo‐controlled study of molnupiravir in healthy Japanese to support special approval in Japan to treat COVID‐19
A phase I, randomized, placebo‐controlled study of molnupiravir in healthy Japanese to support special approval in Japan to treat COVID‐19 Open
Molnupiravir (MK‐4482) is an oral prodrug of the antiviral ribonucleoside analog, N ‐hydroxycytidine (NHC), which has activity against RNA viruses, including severe acute respiratory syndrome‐coronavirus 2 (SARS‐CoV‐2). We conducted a phas…
View article: Physiologically‐based pharmacokinetic model‐based translation of <scp>OATP1B</scp>‐mediated drug–drug interactions from coproporphyrin I to probe drugs
Physiologically‐based pharmacokinetic model‐based translation of <span>OATP1B</span>‐mediated drug–drug interactions from coproporphyrin I to probe drugs Open
The accurate prediction of OATP1B‐mediated drug–drug interactions (DDIs) is challenging for drug development. Here, we report a physiologically‐based pharmacokinetic (PBPK) model analysis for clinical DDI data generated in heathy subjects …
View article: Effect of Cyclosporin A and Impact of Dose Staggering on OATP1B1/1B3 Endogenous Substrates and Drug Probes for Assessing Clinical Drug Interactions
Effect of Cyclosporin A and Impact of Dose Staggering on OATP1B1/1B3 Endogenous Substrates and Drug Probes for Assessing Clinical Drug Interactions Open
This study was designed to assess the quantitative performance of endogenous biomarkers for organic anion transporting polypeptide (OATP) 1B1/1B3‐mediated drug‐drug interactions (DDIs). Ten healthy volunteers orally received OATP1B1/1B3 pr…
View article: Pharmacokinetics, Safety, and Tolerability of NPC‐21, an Anti‐Cytomegalovirus Monoclonal Antibody, in Healthy Japanese and White Adult Men: A Randomized, Placebo‐Controlled, First‐in‐Human Phase 1 Study
Pharmacokinetics, Safety, and Tolerability of NPC‐21, an Anti‐Cytomegalovirus Monoclonal Antibody, in Healthy Japanese and White Adult Men: A Randomized, Placebo‐Controlled, First‐in‐Human Phase 1 Study Open
NPC‐21 (EV2038) is a fully human monoclonal antibody that targets the antigenic domain 1 of glycoprotein B on the human cytomegalovirus (hCMV) envelope. NPC‐21 has been shown to have broadly neutralizing activity and to inhibit cell‐to‐cel…
View article: A phase 1 multiple‐ascending dose study of tirzepatide in <scp>Japanese</scp> participants with type 2 diabetes
A phase 1 multiple‐ascending dose study of tirzepatide in <span>Japanese</span> participants with type 2 diabetes Open
Aim To investigate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of tirzepatide in Japanese participants with type 2 diabetes (T2D). Methods This phase 1, double‐blind, placebo‐controlled, parallel‐dose, multip…
View article: A Phase 1 Study of KHK4083: A Single‐Blind, Randomized, Placebo‐Controlled Single‐Ascending‐Dose Study in Healthy Adults and an Open‐Label Multiple‐Dose Study in Patients With Ulcerative Colitis
A Phase 1 Study of KHK4083: A Single‐Blind, Randomized, Placebo‐Controlled Single‐Ascending‐Dose Study in Healthy Adults and an Open‐Label Multiple‐Dose Study in Patients With Ulcerative Colitis Open
OX40 plays an essential role in maintaining late T‐cell proliferation and survival by suppressing apoptosis and by inducing T‐cell memory formation. Here, we report the results of the phase 1 study of KHK4083, a fully human antimonoclonal …
View article: Identification of Appropriate Endogenous Biomarker for Risk Assessment of Multidrug and Toxin Extrusion Protein‐Mediated Drug‐Drug Interactions in Healthy Volunteers
Identification of Appropriate Endogenous Biomarker for Risk Assessment of Multidrug and Toxin Extrusion Protein‐Mediated Drug‐Drug Interactions in Healthy Volunteers Open
Endogenous biomarkers are emerging to advance clinical drug‐drug interaction (DDI) risk assessment in drug development. Twelve healthy subjects received a multidrug and toxin exclusion protein (MATE) inhibitor (pyrimethamine, 10, 25, and 7…
View article: A drug–drug interaction study of a novel, selective urate reabsorption inhibitor dotinurad and the non-steroidal anti-inflammatory drug oxaprozin in healthy adult males
A drug–drug interaction study of a novel, selective urate reabsorption inhibitor dotinurad and the non-steroidal anti-inflammatory drug oxaprozin in healthy adult males Open
Background Dotinurad is a novel, selective urate reabsorption inhibitor, which reduces serum uric acid levels by inhibiting the urate transporter 1. The results of nonclinical studies indicated the possibility that the concomitant use of t…
View article: Pharmacokinetics and Safety of a Single Oral Dose of Peficitinib (ASP015K) in Japanese Subjects With Normal and Impaired Hepatic Function
Pharmacokinetics and Safety of a Single Oral Dose of Peficitinib (ASP015K) in Japanese Subjects With Normal and Impaired Hepatic Function Open
Peficitinib (ASP015K) is a novel Janus kinase inhibitor developed for the treatment of rheumatoid arthritis (RA). The impact of hepatic impairment on the peficitinib pharmacokinetic (PK) and safety profile was investigated in non‐RA subjec…
View article: Dotinurad: a clinical pharmacokinetic study of a novel, selective urate reabsorption inhibitor in subjects with hepatic impairment
Dotinurad: a clinical pharmacokinetic study of a novel, selective urate reabsorption inhibitor in subjects with hepatic impairment Open
Background Dotinurad is a novel, selective urate reabsorption inhibitor, which reduces serum uric acid levels by inhibiting the urate transporter 1 (URAT1). We compared the pharmacokinetics (PK), pharmacodynamics (PD), and safety of dotinu…
View article: Pharmacokinetics and Safety of a Single Oral Dose of Peficitinib (ASP015K) in Japanese Subjects with Normal and Impaired Renal Function
Pharmacokinetics and Safety of a Single Oral Dose of Peficitinib (ASP015K) in Japanese Subjects with Normal and Impaired Renal Function Open
NCT02603497.
View article: Dose‐Dependent Inhibition of OATP1B by Rifampicin in Healthy Volunteers: Comprehensive Evaluation of Candidate Biomarkers and OATP1B Probe Drugs
Dose‐Dependent Inhibition of OATP1B by Rifampicin in Healthy Volunteers: Comprehensive Evaluation of Candidate Biomarkers and OATP1B Probe Drugs Open
To address the most appropriate endogenous biomarker for drug–drug interaction risk assessment, eight healthy subjects received an organic anion transporting polypeptide 1B (OATP1B) inhibitor (rifampicin, 150, 300, and 600 mg), and a probe…
View article: The Bioequivalence and Effect of Food on the Pharmacokinetics of a Fixed‐Dose Combination Tablet Containing Rosuvastatin and Ezetimibe in Healthy Japanese Subjects
The Bioequivalence and Effect of Food on the Pharmacokinetics of a Fixed‐Dose Combination Tablet Containing Rosuvastatin and Ezetimibe in Healthy Japanese Subjects Open
Certain patient populations are unable to achieve the recommended low‐density lipoprotein cholesterol goals with statin monotherapy alone. Such patients may benefit from concomitant therapy with ezetimibe (EZE) 10 mg added on to a statin. …
View article: Effects of proton pump inhibitors, esomeprazole and vonoprazan, on the disposition of proguanil, a CYP2C19 substrate, in healthy volunteers
Effects of proton pump inhibitors, esomeprazole and vonoprazan, on the disposition of proguanil, a CYP2C19 substrate, in healthy volunteers Open
Aims Vonoprazan, a new class of potassium‐competitive proton pump inhibitors has been found to attenuate the antiplatelet function of clopidogrel in a recent clinical study, despite weak in vitro activity against CYP2C19. To elucidate the …
View article: Short-time Fourier Transform of Free Induction Decays for the Analysis of Serum Using Proton Nuclear Magnetic Resonance
Short-time Fourier Transform of Free Induction Decays for the Analysis of Serum Using Proton Nuclear Magnetic Resonance Open
Proton nuclear magnetic resonance (NMR) is useful for the analysis of biological samples such as serum. Free induction decays (FIDs) are NMR signals that follow a radio-frequency pulse applied at the resonance frequency. Short-time Fourier…
View article: <b>In vitro enhancement of ATP in human erythrocytes from a healthy subject and two patients with thalassemia and hemoglobinopathy.</b>
<b>In vitro enhancement of ATP in human erythrocytes from a healthy subject and two patients with thalassemia and hemoglobinopathy.</b> Open
Objective: To examine whether the supplementation of inosine augments ATP in vitro in human erythrocytes incubated in saline.
View article: Evaluation of Food and Spherical Carbon Adsorbent Effects on the Pharmacokinetics of Roxadustat in Healthy Nonelderly Adult Male Japanese Subjects
Evaluation of Food and Spherical Carbon Adsorbent Effects on the Pharmacokinetics of Roxadustat in Healthy Nonelderly Adult Male Japanese Subjects Open
Roxadustat is a hypoxia‐inducible factor prolyl hydroxylase inhibitor in late‐stage clinical development for the treatment of anemia in chronic kidney disease. Spherical carbon adsorbent (SCA) is used in patients with chronic kidney diseas…
View article: Issue Information
Issue Information Open
Aims and Scope: For more than 50 years, clinical pharmacologists, clinical and pharmaceutical researchers, drug development specialists, physicians, nurses, and other medical professionals have relied on The Journal of Clinical Pharmacolog…
View article: Pharmacokinetics and Safety of a Single Oral Dose of Mirogabalin in Japanese Subjects With Varying Degrees of Renal Impairment
Pharmacokinetics and Safety of a Single Oral Dose of Mirogabalin in Japanese Subjects With Varying Degrees of Renal Impairment Open
Mirogabalin (DS‐5565) is a novel preferentially selective α 2 δ‐1 ligand being developed for the treatment of diabetic peripheral neuropathic pain and postherpetic neuralgia. The current multicenter open‐label study determined the effect o…
View article: Luseogliflozin, an SGLT2 Inhibitor, in Japanese Patients With Mild/Moderate Hepatic Impairment: A Pharmacokinetic Study
Luseogliflozin, an SGLT2 Inhibitor, in Japanese Patients With Mild/Moderate Hepatic Impairment: A Pharmacokinetic Study Open
This open‐label, parallel‐group study evaluated the effect of mild and moderate hepatic impairment on the pharmacokinetics of a single dose of luseogliflozin in Japanese subjects. Thirteen subjects with hepatic impairment (mild, n = 8; mod…