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Author Shin Irie

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TAS-303 effects on urethral sphincter function in women with stress urinary incontinence: phase I study.

Makoto Yono, Shin Irie, Momokazu Gotoh,

INTRODUCTION AND HYPOTHESIS:TAS-303, which selectively inhibits noradrenaline reuptake, was developed for treating stress urinary incontinence (SUI). The proximal urethra mainly comprises smooth muscle fibers in which α1 adrenergic receptors are abundant. This study was conducted to evaluate the effect of TAS-303 on urethral function and its safety profile in female ... Read more >>

Int Urogynecol J (International urogynecology journal)
[2020, :]

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Comparison of immunogenicity between candidate influenza A(H3N2) virus vaccine strains in Japan: A randomized controlled trial using a monovalent vaccine of A/Saitama/103/2014 (CEXP-002) and A/Hong Kong/4801/2014 (X-263).

Tetsuo Kase, Megumi Inoue, Saeko Morikawa, Hiroko Kumashiro, Satoshi Hiroi, Keiko Nakata, Kazuya Ito, Motoki Ishibashi, Tomomi Tsuru, Shin Irie, Akiko Maeda, Satoko Ohfuji, Wakaba Fukushima, Yoshio Hirota,

BACKGROUND:For the 2017-18 influenza season, A/Saitama/103/2014 (CEXP-002) (Saitama strain) was antigenically more similar to prior circulating strains than A/Hong Kong/4801/2014 (X-263) (Hong Kong strain) in a ferret model and was selected as the A(H3N2) vaccine virus strain in Japan. However, the Saitama strain grew poorly, and the Japanese government switched ... Read more >>

Vaccine (Vaccine)
[2020, 38(42):6524-6532]

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Pharmacokinetic interactions of esaxerenone with amlodipine and digoxin in healthy Japanese subjects.

Yoshiaki Kirigaya, Masanari Shiramoto, Tomoko Ishizuka, Hinako Uchimaru, Shin Irie, Manabu Kato, Takako Shimizu, Takafumi Nakatsu, Yasuhiro Nishikawa, Hitoshi Ishizuka,

BACKGROUND:To investigate the effects of coadministration of esaxerenone with amlodipine on the pharmacokinetics (PK) of each drug, and of esaxerenone on the PK of digoxin. METHODS:In three open-label, single-sequence, crossover studies, healthy Japanese males received single oral doses of esaxerenone 2.5 mg (Days 1, 15), with amlodipine 10 mg/day (Days 8-18) (Study ... Read more >>

BMC Pharmacol Toxicol (BMC pharmacology & toxicology)
[2020, 21(1):55]

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Variability of post-void residual urine volume and bladder voiding efficiency in patients with underactive bladder.

Makoto Yono, Kazuya Ito, Megumi Oyama, Takanori Tanaka, Shin Irie, Yoshihisa Matsukawa, Noritoshi Sekido, Masaki Yoshida, Olivier van Till, Osamu Yamaguchi,

OBJECTIVES:Post-void residual urine volume (PVR) and bladder voiding efficiency (BVE) are widely used as clinical parameters to evaluate patients with voiding dysfunction. The present study was conducted to assess the variability of PVR and BVE determinations in patients with underactive bladder (UAB). In addition, we focused on the bladder volume ... Read more >>

Low Urin Tract Symptoms (Lower urinary tract symptoms)
[2020, :]

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Effects of itraconazole and rifampicin on the single-dose pharmacokinetics of the nonsteroidal mineralocorticoid receptor blocker esaxerenone in healthy Japanese subjects.

Yoshiaki Kirigaya, Masanari Shiramoto, Tomoko Ishizuka, Hinako Uchimaru, Shin Irie, Manabu Kato, Takako Shimizu, Takafumi Nakatsu, Yasuhiro Nishikawa, Hitoshi Ishizuka,

AIMS:To investigate the effects of the strong cytochrome P450 (CYP) 3A inhibitor itraconazole and the strong CYP3A inducer rifampicin on the pharmacokinetics of single-dose esaxerenone, a nonsteroidal mineralocorticoid receptor blocker, in healthy Japanese subjects. METHODS:Two open-label, single-sequence, crossover studies were conducted in healthy Japanese males aged 20-45 years. In Study ... Read more >>

Br J Clin Pharmacol (British journal of clinical pharmacology)
[2020, 86(10):2070-2079]

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Determination of the Kinetic Parameters for 123I Uptake by the Thyroid, Thyroid Weights, and Thyroid Volumes in Present-day Healthy Japanese Volunteers.

Takashi Kudo, Akihiro Inano, Sanae Midorikawa, Hitoshi Kubo, Kino Hayashi, Sawako Nakashima, Chizu Fukushima, Kazuya Maeda, Noboru Oriuchi, Shin Irie, Shunichi Yamashita, Hiroyuki Kusuhara,

The purpose of this study was to evaluate the kinetic parameters that determine the uptake rate of radioiodide in the thyroid over 24 h after administration and to estimate thyroid volumes/masses of present-day Japanese. Methods: We determined the thyroid uptake rate of I in healthy male Japanese after oral administration ... Read more >>

Health Phys (Health physics)
[2020, 118(4):417-426]

Cited: 3 times

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Levocetirizine Oral Disintegrating Tablet: A Randomized Open-Label Crossover Bioequivalence Study in Healthy Japanese Volunteers.

Hiroko Ino, Masanari Shiramoto, Takashi Eto, Miwa Haranaka, Shin Irie, Takumi Terao, Hirofumi Ogura, Akira Wakamatsu, Keiko Hoyano, Atsushi Nakano,

Levocetirizine is classified as a second-generation antihistamine. Levocetirizine is available for the treatment of allergic disorders such as allergic rhinitis and chronic idiopathic urticaria. This was a single-center, single-dose, open-label, randomized, 2-way crossover study in healthy Japanese male subjects consisting of 2 parts. Part 1 compared the bioavailability of levocetirizine ... Read more >>

Clin Pharmacol Drug Dev (Clinical pharmacology in drug development)
[2020, 9(7):805-812]

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A Phase 1, Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Subcutaneous Tezepelumab in Healthy Japanese Men.

Kei Sakamoto, Shunji Matsuki, Shin Irie, Naoki Uchida, Nobuya Hayashi, Masato Horiuchi, Song Ren,

Tezepelumab, a human immunoglobulin G2 monoclonal antibody against thymic stromal lymphopoietin, is currently under clinical development for the treatment of severe, uncontrolled asthma. This phase 1, randomized, placebo-controlled, single-ascending-dose study assessed the safety, tolerability, pharmacokinetics, and immunogenicity of subcutaneous tezepelumab in healthy Japanese men. Participants were assigned to 1 of ... Read more >>

Clin Pharmacol Drug Dev (Clinical pharmacology in drug development)
[2020, 9(7):833-840]

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Elucidation of N 1-methyladenosine as a Potential Surrogate Biomarker for Drug Interaction Studies Involving Renal Organic Cation Transporters.

Takeshi Miyake, Tadahaya Mizuno, Issey Takehara, Tatsuki Mochizuki, Miyuki Kimura, Shunji Matsuki, Shin Irie, Nobuaki Watanabe, Yukio Kato, Ichiro Ieiri, Kazuya Maeda, Osamu Ando, Hiroyuki Kusuhara,

Endogenous substrates are emerging biomarkers for drug transporters, which serve as surrogate probes in drug-drug interaction (DDI) studies. In this study, the results of metabolome analysis using wild-type and Oct1/2 double knockout mice suggested that N 1-methyladenosine (m1A) was a novel organic cation transporter (OCT) 2 substrate. An in vitro ... Read more >>

Drug Metab. Dispos. (Drug metabolism and disposition: the biological fate of chemicals)
[2019, 47(11):1270-1280]

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Treatment Recommendations for Urological Symptoms in Cancer Patients: Clinical Guidelines from the Japanese Society for Palliative Medicine.

Tomoyasu Tsushima, Takafumi Miura, Takahiko Hachiya, Ichiro Nakamura, Toyoko Yamato, Takeshi Kishida, Yoshinori Tanaka, Shin Irie, Norio Meguro, Takashi Kawahara, Nobuhisa Nakajima,

BACKGROUND:Urological symptoms such as gross hematuria, lower and upper urinary tract symptoms, and bladder pain are common in and distressing for patients with advanced cancer. Although palliation of urological symptoms is important to improve the quality of life of cancer patients and their families and caregivers, clinical guidelines for managing ... Read more >>

J Palliat Med (Journal of palliative medicine)
[2019, 22(1):54-61]

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Pharmacokinetics of Tenofovir Alafenamide, Tenofovir, and Emtricitabine Following Administration of Coformulated Emtricitabine/Tenofovir Alafenamide in Healthy Japanese Subjects.

Hiroyuki Yamada, Takuma Yonemura, Takanori Nemoto, Noriko Ninomiya, Shin Irie,

A fixed-dose combination of tenofovir alafenamide (TAF) and emtricitabine (FTC) is available in 2 tablet strengths in Japan (FTC/TAF 200/10 mg and FTC/TAF 200/25 mg). These are used once daily in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 infection. The primary objective of this study ... Read more >>

Clin Pharmacol Drug Dev (Clinical pharmacology in drug development)
[2019, 8(4):511-520]

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Effects of magnesium oxide on pharmacokinetics of L-dopa/carbidopa and assessment of pharmacodynamic changes by a model-based simulation.

Yushi Kashihara, Yui Terao, Kensaku Yoda, Takeshi Hirota, Toshio Kubota, Miyuki Kimura, Shunji Matsuki, Masaaki Hirakawa, Shin Irie, Ichiro Ieiri,

BACKGROUND:Magnesium oxide (MgO) is often co-prescribed with L-dopa/carbidopa (LDCD) to improve constipation in Parkinson's disease patients. The mixing of L-dopa and MgO has been shown to degrade L-dopa; however, there is no interaction study on humans. We proposed mechanisms for the interaction between LDCD and MgO and conducted pharmacokinetic studies ... Read more >>

Eur. J. Clin. Pharmacol. (European journal of clinical pharmacology)
[2019, 75(3):351-361]

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Safety, Tolerability, and Pharmacokinetics of NK-104-NP.

Kaku Nakano, Tetsuya Matoba, Jun-Ichiro Koga, Yushi Kashihara, Masato Fukae, Ichiro Ieiri, Masanari Shiramoto, Shin Irie, Junji Kishimoto, Koji Todaka, Kensuke Egashira,

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 not been verified in clinical ... Read more >>

Int Heart J (International heart journal)
[2018, 59(5):1015-1025]

Cited: 4 times

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Effect of OATP1B1 genotypes on plasma concentrations of endogenous OATP1B1 substrates and drugs, and their association in healthy volunteers.

Daiki Mori, Yushi Kashihara, Takashi Yoshikado, Miyuki Kimura, Takeshi Hirota, Shunji Matsuki, Kazuya Maeda, Shin Irie, Ichiro Ieiri, Yuichi Sugiyama, Hiroyuki Kusuhara,

This study aimed to elucidate the impact of OATP1B1 genotype (*1b/*1b, *1b/*15, and *15/*15) on plasma concentrations of endogenous OATP1B1 substrates. Healthy volunteers with OATP1B1 *1b/*1b (n = 10), *1b/*15 (n = 7), or *15/*15 (n = 2) received oral administration of a cocktail of statins (atorvastatin, pitavastatin, rosuvastatin, and fluvastatin). Mean area under the plasma ... Read more >>

Drug Metab. Pharmacokinet. (Drug metabolism and pharmacokinetics)
[2019, 34(1):78-86]

Cited: 2 times

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Prior vaccinations improve immunogenicity of inactivated influenza vaccine in young children aged 6 months to 3 years: A cohort study.

Kazuya Ito, Ayumi Mugitani, Shin Irie, Motoki Ishibashi, Yoshio Takasaki, Shizuo Shindo, Takashi Yokoyama, Yuji Yamashita, Keigo Shibao, Hideki Koyanagi, Wakaba Fukushima, Satoko Ohfuji, Akiko Maeda, Tetsuo Kase, Yoshio Hirota,

In young children, infrequent antigen exposure, which is partly characterized by fewer vaccinations, may be a factor impairing the immunogenicity of inactivated influenza vaccine.We assessed the effects of prior vaccinations on age-specific immune responses in Japanese children aged 6 months to 3 years, using data from a cohort study with ... Read more >>

(Medicine)
[2018, 97(29):e11551]

Cited: 3 times

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G protein-coupled receptor 119 agonist DS-8500a effects on pancreatic β-cells in Japanese type 2 diabetes mellitus patients.

Hirotaka Watada, Masanari Shiramoto, Shin Irie, Yasuo Terauchi, Yuichiro Yamada, Kazuhito Shiosakai, Yusuke Myobatake, Takashi Taguchi,

AIMS/INTRODUCTION:Pancreatic β-cell dysfunction contributes to type 2 diabetes mellitus progression. Drugs that improve insulin secretion might be a valuable treatment approach. The present study aimed to evaluate the effect of the G protein-coupled receptor 119 agonist DS-8500a on insulin secretory capacity in Japanese type 2 diabetes mellitus patients. MATERIALS AND ... Read more >>

J Diabetes Investig (Journal of diabetes investigation)
[2019, 10(1):84-93]

Cited: 1 time

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A Randomized Trial Investigating the Pharmacokinetics, Pharmacodynamics, and Safety of Subcutaneous Semaglutide Once-Weekly in Healthy Male Japanese and Caucasian Subjects.

Ippei Ikushima, Lene Jensen, Anne Flint, Tomoyuki Nishida, Jeppe Zacho, Shin Irie,

INTRODUCTION:Semaglutide is a glucagon-like peptide-1 analogue for once-weekly subcutaneous treatment of type 2 diabetes. This trial compared the pharmacokinetics, pharmacodynamics, and safety of semaglutide in Japanese and Caucasian subjects. METHODS:In this single-center, double-blind, parallel-group, 13-week trial, 44 healthy male subjects (22 Japanese, 22 Caucasian) were randomized within each race to ... Read more >>

Adv Ther (Advances in therapy)
[2018, 35(4):531-544]

Cited: 2 times

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Immunogenicity study to investigate the interchangeability among three different types of polio vaccine: A cohort study in Japan.

Satoko Ohfuji, Kazuya Ito, Motoki Ishibashi, Shizuo Shindo, Yoshio Takasaki, Takashi Yokoyama, Takato Yokoyama, Yuji Yamashita, Keigo Shibao, Takashi Nakano, Tomomi Tsuru, Shin Irie, Yoshio Hirota,

In Japan, the routine immunization program with oral polio vaccine (OPV) has been suspended since September 2012, when a program with 4 doses of inactivated monovalent polio vaccine (IPV) or quadrivalent vaccine against diphtheria, pertussis, and tetanus with IPV (DTaP-IPV) was introduced. The aim of this study was to examine ... Read more >>

(Medicine)
[2017, 96(23):e7073]

Cited: 0 times

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Effects of a Nutritional Protein-Rich Drink on the Pharmacokinetics of Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Alafenamide, and Tenofovir Compared With a Standard Meal in Healthy Japanese Male Subjects.

Hiroyuki Yamada, Ippei Ikushima, Takanori Nemoto, Tomohiro Ishikawa, Noriko Ninomiya, Shin Irie,

This study investigated the effects of ingested meal types on the pharmacokinetics of elvitegravir (EVG), cobicistat (COBI), emtricitabine (FTC), tenofovir alafenamide (TAF), and tenofovir (TFV) following a single administration of the single-tablet regimen (STR) of EVG/COBI/FTC/TAF (150/150/200/10 mg) in Japanese HIV-negative healthy subjects (n = 12). In this open-label, randomized, 3-way crossover study, ... Read more >>

Clin Pharmacol Drug Dev (Clinical pharmacology in drug development)
[2018, 7(2):132-142]

Cited: 1 time

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Involvement of Organic Cation Transporters in the Kinetics of Trimethylamine N-oxide.

Takeshi Miyake, Tadahaya Mizuno, Tatsuki Mochizuki, Miyuki Kimura, Shunji Matsuki, Shin Irie, Ichiro Ieiri, Kazuya Maeda, Hiroyuki Kusuhara,

Recent studies suggest that trimethylamine N-oxide (TMAO) is associated with the development of chronic kidney disease and heart failure. In this study, we investigated the importance of organic cation transporters (OCTs) in the clearance and tissue distribution of TMAO. The low-affinity and high-capacity transport of TMAO by mouse and human ... Read more >>

J Pharm Sci (Journal of pharmaceutical sciences)
[2017, 106(9):2542-2550]

Cited: 9 times

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Small-Dosing Clinical Study: Pharmacokinetic, Pharmacogenomic (SLCO2B1 and ABCG2), and Interaction (Atorvastatin and Grapefruit Juice) Profiles of 5 Probes for OATP2B1 and BCRP.

Yushi Kashihara, Ichiro Ieiri, Takashi Yoshikado, Kazuya Maeda, Masato Fukae, Miyuki Kimura, Takeshi Hirota, Shunji Matsuki, Shin Irie, Noritomo Izumi, Hiroyuki Kusuhara, Yuichi Sugiyama,

The aims of this study were (1) to investigate the effects of atorvastatin (10 mg, therapeutic dose) and grapefruit juice (GFJ), inhibitors of OATP2B1, on the pharmacokinetics of substrates for OATP2B1 and BCRP under oral small-dosing conditions (300 μg sulfasalazine, 250 μg rosuvastatin, 300 μg glibenclamide, 1200 μg celiprolol, and ... Read more >>

J Pharm Sci (Journal of pharmaceutical sciences)
[2017, 106(9):2688-2694]

Cited: 7 times

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Genetic polymorphisms of enzyme proteins and transporters related to methotrexate response and pharmacokinetics in a Japanese population.

Masayuki Hashiguchi, Mikiko Shimizu, Jun Hakamata, Tomomi Tsuru, Takanori Tanaka, Midori Suzaki, Kumika Miyawaki, Takeshi Chiyoda, Osamu Takeuchi, Jiro Hiratsuka, Shin Irie, Junya Maruyama, Mayumi Mochizuki,

BACKGROUND:Methotrexate (MTX) is currently the anchor drug widely used worldwide in the treatment of rheumatoid arthritis (RA). However, the therapeutic response to MTX has been shown to vary widely among individuals, genders and ethnic groups. The reason for this has been not clarified but it is considered to be partially ... Read more >>

(Journal of pharmaceutical health care and sciences)
[2016, 2:35]

Cited: 2 times

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Effects of DPP-4 inhibitor linagliptin and GLP-1 receptor agonist liraglutide on physiological response to hypoglycaemia in Japanese subjects with type 2 diabetes: A randomized, open-label, 2-arm parallel comparative, exploratory trial.

Daisuke Yabe, Takashi Eto, Masanari Shiramoto, Shin Irie, Kenta Murotani, Yusuke Seino, Hitoshi Kuwata, Takeshi Kurose, Susumu Seino, Bo Ahrén, Yutaka Seino,

Dipeptidyl peptidase-4 (DPP-4) inhibitors reduce the risk of hypoglycaemia, possibly through augmentation of glucose-dependent insulinotropic polypeptide (GIP) action, but not that of glucagon-like peptide-1 (GLP-1) on glucagon secretion. To examine this model in Japanese individuals with type 2 diabetes (T2D), the effects of the DPP-4 inhibitor linagliptin on glucagon and ... Read more >>

Diabetes Obes Metab (Diabetes, obesity & metabolism)
[2017, 19(3):442-447]

Cited: 11 times

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Efficacy and safety of 3 day versus 7 day cefditoren pivoxil regimens for acute uncomplicated cystitis: multicentre, randomized, open-label trial.

Takuya Sadahira, Koichiro Wada, Motoo Araki, Ayano Ishii, Atsushi Takamoto, Yasuyuki Kobayashi, Masami Watanabe, Toyohiko Watanabe, Yasutomo Nasu, Hiromi Kumon, ,

Fluoroquinolone-non-susceptible Escherichia coli isolated from patients with acute uncomplicated cystitis are a matter of increasing concern. Cefditoren pivoxil is an oral, β-lactamase-stable, extended-spectrum cephalosporin that is effective against fluoroquinolone-non-susceptible bacteria.To evaluate the clinical and microbiological efficacies of cefditoren pivoxil against acute uncomplicated cystitis and to determine the optimal duration of ... Read more >>

J. Antimicrob. Chemother. (The Journal of antimicrobial chemotherapy)
[2017, 72(2):529-534]

Cited: 2 times

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Sex Differences in mRNA Expression of Reduced Folate Carrier-1, Folypolyformyl Glutamate Synthase, and γ-Glutamyl Hydrolase in a Healthy Japanese Population.

Masayuki Hashiguchi, Takanori Tanaka, Mikiko Shimizu, Tomomi Tsuru, Takeshi Chiyoda, Kumika Miyawaki, Shin Irie, Osamu Takeuchi, Jun Hakamata, Mayumi Mochizuki,

Sex differences in the prevalence of autoimmune diseases such as rheumatoid arthritis (RA) are well known, but little is known about those differences in relation to therapeutic response. Reduced folate carrier-1 (RFC-1), folypolyformyl glutamate synthase (FPGS), and γ-glutamyl hydrolase (GGH) are important transporters and enzymes that convert methotrexate (MTX) in ... Read more >>

J Clin Pharmacol (Journal of clinical pharmacology)
[2016, 56(12):1563-1569]

Cited: 1 time

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