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Article ; Online: Correction: Radiation dosimetry and pharmacokinetics of the tau PET tracer florzolotau (18F) in healthy Japanese subjects.

Miyamoto, Masaomi / Okuyama, Chio / Kagawa, Shinya / Kusano, Kuninori / Takahashi, Masaaki / Takahata, Keisuke / Jang, Ming-Kuei / Yamauchi, Hiroshi

Annals of nuclear medicine

2024 Volume 38, Issue 4, Page(s) 328

Language	English
Publishing date	2024-03-07
Publishing country	Japan
Document type	Published Erratum
ZDB-ID	1146984-5
ISSN	1864-6433 ; 0914-7187
ISSN (online)	1864-6433
ISSN	0914-7187
DOI	10.1007/s12149-024-01917-5
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Article ; Online: Radiation dosimetry and pharmacokinetics of the tau PET tracer florzolotau (18F) in healthy Japanese subjects.

Miyamoto, Masaomi / Okuyama, Chio / Kagawa, Shinya / Kusano, Kuninori / Takahashi, Masaaki / Takahata, Keisuke / Jang, Ming-Kuei / Yamauchi, Hiroshi

Annals of nuclear medicine

2023 Volume 37, Issue 5, Page(s) 300–309

Abstract: Objective: Abnormal aggregation of tau in the brain is a major contributing factor in various neurodegenerative diseases. Florzolotau (18F) (florzolotau, APN-1607, PM-PBB3) has been shown to be a probe for tau fibrils in an animal model and patients ... ...

Abstract	Objective: Abnormal aggregation of tau in the brain is a major contributing factor in various neurodegenerative diseases. Florzolotau (18F) (florzolotau, APN-1607, PM-PBB3) has been shown to be a probe for tau fibrils in an animal model and patients with Alzheimer's disease and those with non-Alzheimer's disease tauopathies. The objective of this study is to evaluate the safety, pharmacokinetics, and radiation dose following a single intravenous administration of florzolotau in healthy Japanese subjects. Methods: Three healthy male Japanese subjects aged between 20 and 64 were enrolled in this study. Subjects were determined to be eligible based on the screening assessments at the study site. Subjects received a single intravenous dose of 195.0 ± 0.5 MBq of florzolotau and underwent the whole-body PET scan 10 times in total to calculate absorbed doses to major organs/tissues and effective dose. Radioactivities in whole blood and urine were also measured for pharmacokinetic evaluation. Absorbed doses to major organs/tissues and effective dose were estimated using the medical internal radiation dose (MIRD) method. Vital signs, electrocardiography (ECG), and blood tests were done for safety evaluation. Results: The intravenous injection of florzolotau was well tolerated. There were no adverse events or clinically detectable pharmacologic effects related to the tracer in any subjects. No significant changes in vital signs and ECG were observed. The highest mean initial uptake at 15 min after injection was in the liver (29.0 ± 4.0%ID), intestine (4.69 ± 1.65%ID), and brain (2.13 ± 0.18%ID). The highest absorbed dose was 508 μGy/MBq of the gallbladder wall, followed by the liver of 79.4 μGy/MBq, the pancreas of 42.5 μGy/MBq, and the upper large intestine of 34.2 μGy/MBq. The effective dose was calculated as 19.7 μSv/MBq according to the tissue weighting factor reported by ICRP-103. Conclusion: Florzolotau intravenous injection was well tolerated in healthy male Japanese subjects. The effective dose was determined as 3.61 mSv when 185 MBq florzolotau was given.
MeSH term(s)	Humans ; Male ; East Asian People ; Positron-Emission Tomography/methods ; Radiometry ; Radiopharmaceuticals/pharmacokinetics ; Tissue Distribution ; Young Adult ; Adult ; Middle Aged
Chemical Substances	Radiopharmaceuticals
Language	English
Publishing date	2023-03-09
Publishing country	Japan
Document type	Journal Article
ZDB-ID	1146984-5
ISSN	1864-6433 ; 0914-7187
ISSN (online)	1864-6433
ISSN	0914-7187
DOI	10.1007/s12149-023-01828-x
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Article: [A novel therapeutic drug: ramelteon].

Miyamoto, Masaomi

Nihon rinsho. Japanese journal of clinical medicine

2009 Volume 67, Issue 8, Page(s) 1595–1600

Abstract: Current treatment of insomnia with hypnotics, GABA(A) receptor modulators, induces various side effects, including cognitive impairment, motor disturbance, dependence, tolerance, hang-over, and rebound insomnia. Ramelteon (Rozerem) is an orally active, ... ...

Abstract	Current treatment of insomnia with hypnotics, GABA(A) receptor modulators, induces various side effects, including cognitive impairment, motor disturbance, dependence, tolerance, hang-over, and rebound insomnia. Ramelteon (Rozerem) is an orally active, highly selective melatonin MT1/MT2 receptor agonist. Unlike the sedative hypnotics that target GABA(A) receptor complexes, ramelteon is a chronohypnotic that acts on the melatonin MT1 and MT2 receptors, which are primarily located in the suprachiasmatic nucleus. Ramelteon has demonstrated sleep-promoting effects in clinical trials, and coupled with its favorable safety profile and lack of abuse potential or dependence, this chronohypnotic provides an important treatment option for insomnia.
MeSH term(s)	Humans ; Indenes/therapeutic use ; Receptor, Melatonin, MT1/agonists ; Receptor, Melatonin, MT2/agonists ; Sleep Initiation and Maintenance Disorders/drug therapy
Chemical Substances	Indenes ; Receptor, Melatonin, MT1 ; Receptor, Melatonin, MT2 ; ramelteon (901AS54I69)
Language	Japanese
Publishing date	2009-08
Publishing country	Japan
Document type	English Abstract ; Journal Article ; Review
ZDB-ID	390903-7
ISSN	0047-1852
ISSN	0047-1852
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Zs.A 429: Show issues

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Article ; Online: Pharmacology of ramelteon, a selective MT1/MT2 receptor agonist: a novel therapeutic drug for sleep disorders.

Miyamoto, Masaomi

CNS neuroscience & therapeutics

2009 Volume 15, Issue 1, Page(s) 32–51

Abstract: An estimated one-third of the general population is affected by insomnia, and this number is increasing due to more stressful working conditions and the progressive aging of society. However, current treatment of insomnia with hypnotics, gamma- ... ...

Abstract	An estimated one-third of the general population is affected by insomnia, and this number is increasing due to more stressful working conditions and the progressive aging of society. However, current treatment of insomnia with hypnotics, gamma-aminobutyric acid A (GABA(A)) receptor modulators, induces various side effects, including cognitive impairment, motor disturbance, dependence, tolerance, hangover, and rebound insomnia. Ramelteon (Rozerem; Takeda Pharmaceutical Company Limited, Osaka, Japan) is an orally active, highly selective melatonin MT(1)/MT(2) receptor agonist. Unlike the sedative hypnotics that target GABA(A) receptor complexes, ramelteon is a chronohypnotic that acts on the melatonin MT(1) and MT(2) receptors, which are primarily located in the suprachiasmatic nucleus, the body's "master clock." As such, ramelteon possesses the first new therapeutic mechanism of action for a prescription insomnia medication in over three decades. Ramelteon has demonstrated sleep-promoting effects in clinical trials, and coupled with its favorable safety profile and lack of abuse potential or dependence, this chronohypnotic provides an important treatment option for insomnia.
MeSH term(s)	Animals ; Circadian Rhythm/drug effects ; Electroencephalography/drug effects ; Humans ; Indenes/adverse effects ; Indenes/metabolism ; Indenes/pharmacology ; Indenes/therapeutic use ; Learning/drug effects ; Memory/drug effects ; Receptor, Melatonin, MT1/agonists ; Receptor, Melatonin, MT2/agonists ; Reward ; Sleep Wake Disorders/drug therapy ; Substance-Related Disorders/etiology
Chemical Substances	Indenes ; Receptor, Melatonin, MT1 ; Receptor, Melatonin, MT2 ; ramelteon (901AS54I69)
Language	English
Publishing date	2009-03-04
Publishing country	England
Document type	Journal Article ; Review
ZDB-ID	2423461-8
ISSN	1755-5949 ; 1755-5930
ISSN (online)	1755-5949
ISSN	1755-5930
DOI	10.1111/j.1755-5949.2008.00066.x
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Zs.A 4537: Show issues

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Article: [Drugs for insomnia and improving quality of life (QOL): research and development of ramelteon, an MT1/MT2-receptor agonist].

Miyamoto, Masaomi

Nihon yakurigaku zasshi. Folia pharmacologica Japonica

2007 Volume 131, Issue 1, Page(s) 16–21

MeSH term(s)	Animals ; Humans ; Indenes/pharmacology ; Melatonin/physiology ; Quality of Life ; Receptors, Melatonin/drug effects ; Sleep Initiation and Maintenance Disorders/drug therapy
Chemical Substances	Indenes ; Receptors, Melatonin ; ramelteon (901AS54I69) ; Melatonin (JL5DK93RCL)
Language	Japanese
Publishing date	2007-11-06
Publishing country	Japan
Document type	Journal Article ; Review
ZDB-ID	1097532-9
ISSN	1347-8397 ; 0015-5691
ISSN (online)	1347-8397
ISSN	0015-5691
DOI	10.1254/fpj.131.16
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Article: Effect of ramelteon (TAK-375), a selective MT1/MT2 receptor agonist, on motor performance in mice.

Miyamoto, Masaomi

Neuroscience letters

2006 Volume 402, Issue 3, Page(s) 201–204

Abstract: Effect of (S)-N-[2-(1,6,7,8-tetrahydro-2H-indeno-[5,4-b]furan-8-yl)ethyl]propionamide (ramelteon, TAK-375), a selective MT1/MT2 receptor agonist, on motor coordination was studied using rota-rod performance in mice. Ramelteon did not impair rota-rod ... ...

Abstract	Effect of (S)-N-[2-(1,6,7,8-tetrahydro-2H-indeno-[5,4-b]furan-8-yl)ethyl]propionamide (ramelteon, TAK-375), a selective MT1/MT2 receptor agonist, on motor coordination was studied using rota-rod performance in mice. Ramelteon did not impair rota-rod performance at doses of 3, 10 and 30 mg/kg, p.o. Melatonin and N-acetyl-5-hydroxytryptamine (N-acetyl-5-HT), a ligand of MT3 biding site, also had no impairment on the performance, per se. However, in combination with a low dose of diazepam (3mg/kg, p.o.), treatment with melatonin and N-acetyl-5-HT exacerbated the impairment by diazepam. Ramelteon had no significant effect on the diazepam-induced impairment of motor coordination.
MeSH term(s)	Animals ; Indenes/pharmacology ; Male ; Mice ; Mice, Inbred ICR ; Motor Activity/drug effects ; Receptor, Melatonin, MT1/agonists ; Receptor, Melatonin, MT2/agonists
Chemical Substances	Indenes ; Receptor, Melatonin, MT1 ; Receptor, Melatonin, MT2 ; ramelteon (901AS54I69)
Language	English
Publishing date	2006-05-24
Publishing country	Ireland
Document type	Journal Article
ZDB-ID	194929-9
ISSN	1872-7972 ; 0304-3940
ISSN (online)	1872-7972
ISSN	0304-3940
DOI	10.1016/j.neulet.2006.02.049
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Zs.A 1166: Show issues

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Article: [Recent and potential drugs for treatment of insomnia].

Terao, Akira / Miyamoto, Masaomi

Nihon yakurigaku zasshi. Folia pharmacologica Japonica

2007 Volume 129, Issue 1, Page(s) 35–41

MeSH term(s)	Animals ; Azabicyclo Compounds ; Benzodiazepines ; Diphenhydramine ; Drug Design ; Fluorobenzenes ; GABA-A Receptor Agonists ; Histamine H1 Antagonists ; Humans ; Hypnotics and Sedatives ; Indenes ; Orexin Receptors ; Phenols ; Piperazines ; Pyridines ; Receptor, Melatonin, MT1/agonists ; Receptor, Melatonin, MT2/agonists ; Receptors, G-Protein-Coupled/antagonists & inhibitors ; Receptors, Neuropeptide/antagonists & inhibitors ; Serotonin 5-HT2 Receptor Antagonists ; Sleep Initiation and Maintenance Disorders/drug therapy ; Sleep Initiation and Maintenance Disorders/etiology ; Thiophenes ; Zolpidem
Chemical Substances	Azabicyclo Compounds ; Fluorobenzenes ; GABA-A Receptor Agonists ; Histamine H1 Antagonists ; Hypnotics and Sedatives ; Indenes ; Orexin Receptors ; Phenols ; Piperazines ; Pyridines ; Receptor, Melatonin, MT1 ; Receptor, Melatonin, MT2 ; Receptors, G-Protein-Coupled ; Receptors, Neuropeptide ; Serotonin 5-HT2 Receptor Antagonists ; Thiophenes ; zopiclone (03A5ORL08Q) ; Benzodiazepines (12794-10-4) ; SR 46349B (130580-02-8) ; Zolpidem (7K383OQI23) ; indiplon (8BT63DA42E) ; Diphenhydramine (8GTS82S83M) ; ramelteon (901AS54I69)
Language	Japanese
Publishing date	2007-01-01
Publishing country	Japan
Document type	Journal Article ; Review
ZDB-ID	1097532-9
ISSN	1347-8397 ; 0015-5691
ISSN (online)	1347-8397
ISSN	0015-5691
DOI	10.1254/fpj.129.35
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Article ; Online: Pharmacological characterization of M-II, the major human metabolite of ramelteon.

Nishiyama, Keiji / Nishikawa, Hisao / Kato, Koki / Miyamoto, Masaomi / Tsukamoto, Tetsuya / Hirai, Keisuke

Pharmacology

2014 Volume 93, Issue 3-4, Page(s) 197–201

Abstract: The duration of action of melatonin may be important for improvements in sleep efficiency in insomniacs. Ramelteon, a selective melatonin agonist, is primarily metabolized to the active metabolite M-II, which has a longer half-life and greater systemic ... ...

Abstract	The duration of action of melatonin may be important for improvements in sleep efficiency in insomniacs. Ramelteon, a selective melatonin agonist, is primarily metabolized to the active metabolite M-II, which has a longer half-life and greater systemic exposure than ramelteon. Hence, M-II may contribute significantly to the hypnotic benefits of ramelteon. We assessed the ramelteon-like activity of M-II in vitro and in vivo using cats. Binding and functional studies in Chinese hamster ovary cells expressing human melatonin receptors (MT1 or MT2) revealed that M-II binds melatonin receptors with lower affinity (Ki: 114 and 566 pmol/l for MT1 and MT2, respectively) and has lower potency (IC50: 208 and 1,470 pmol/l for MT1 and MT2, respectively) compared with ramelteon. However, higher M-II doses significantly improved sleep in cats. Thus, M-II may contribute to the clinical efficacy of ramelteon.
MeSH term(s)	Animals ; CHO Cells ; Cats ; Cricetinae ; Cricetulus ; Dose-Response Relationship, Drug ; Female ; Half-Life ; Humans ; Hypnotics and Sedatives/administration & dosage ; Hypnotics and Sedatives/pharmacology ; Indenes/administration & dosage ; Indenes/metabolism ; Indenes/pharmacology ; Inhibitory Concentration 50 ; Male ; Receptor, Melatonin, MT1/agonists ; Receptor, Melatonin, MT1/metabolism ; Receptor, Melatonin, MT2/agonists ; Receptor, Melatonin, MT2/metabolism ; Sleep/drug effects
Chemical Substances	Hypnotics and Sedatives ; Indenes ; Receptor, Melatonin, MT1 ; Receptor, Melatonin, MT2 ; ramelteon (901AS54I69)
Language	English
Publishing date	2014
Publishing country	Switzerland
Document type	Comparative Study ; Journal Article
ZDB-ID	206671-3
ISSN	1423-0313 ; 0031-7012
ISSN (online)	1423-0313
ISSN	0031-7012
DOI	10.1159/000362459
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Article: [Preclinical pharmacological profiles and clinical outcome of the novel melatonin-receptor agonist ramelteon (Rozerem 8 mg).].

Hirai, Keisuke / Kato, Koki / Nishikawa, Hisao / Yukuhiro, Nobuhito / Nishiyama, Keiji / Miyamoto, Masaomi

Nihon yakurigaku zasshi. Folia pharmacologica Japonica

2010 Volume 136, Issue 1, Page(s) 51–60

MeSH term(s)	Animals ; Chronic Disease ; Cyclic AMP/metabolism ; Drug Evaluation, Preclinical ; Humans ; Indenes/administration & dosage ; Indenes/adverse effects ; Indenes/pharmacology ; Randomized Controlled Trials as Topic ; Receptors, Melatonin/agonists ; Sleep Initiation and Maintenance Disorders/drug therapy ; Sleep Stages/drug effects ; Substance-Related Disorders ; Suprachiasmatic Nucleus/drug effects ; Suprachiasmatic Nucleus/physiology
Chemical Substances	Indenes ; Receptors, Melatonin ; ramelteon (901AS54I69) ; Cyclic AMP (E0399OZS9N)
Language	Japanese
Publishing date	2010-07-08
Publishing country	Japan
Document type	Journal Article ; Review
ZDB-ID	1097532-9
ISSN	1347-8397 ; 0015-5691
ISSN (online)	1347-8397
ISSN	0015-5691
DOI	10.1254/fpj.136.51
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Article ; Online: Ameliorative effects of a non-competitive BACE1 inhibitor TAK-070 on Aβ peptide levels and impaired learning behavior in aged rats.

Takahashi, Hideki / Fukumoto, Hiroaki / Maeda, Ryouta / Terauchi, Jun / Kato, Kaneyoshi / Miyamoto, Masaomi

Brain research

2010 Volume 1361, Page(s) 146–156

Abstract: We examined the effects of TAK-070, a novel non-competitive β-secretase (BACE1) inhibitor, on the levels of Aβ peptides and behavioral deficits in rats. TAK-070 reduced soluble Aβ40 and Aβ42 levels of the cerebral cortex in a time- and dose-dependent ... ...

Abstract	We examined the effects of TAK-070, a novel non-competitive β-secretase (BACE1) inhibitor, on the levels of Aβ peptides and behavioral deficits in rats. TAK-070 reduced soluble Aβ40 and Aβ42 levels of the cerebral cortex in a time- and dose-dependent manner in young rats. We found that the insoluble Aβ42 content increased significantly with aging from 22 months old without changing Aβ40 content. TAK-070 normalized the Aβ42 levels to those in young rats when they were fed chow containing TAK-070 starting at 19 months old for 6.5 months. Repeated administration of TAK-070 to aged rats for 2 weeks ameliorated the impaired spatial learning in the Morris water maze task and reduced the levels of soluble and insoluble Aβ peptides at doses of 0.3-1mg/kg, (p.o.). Interestingly, TAK-070 significantly recovered the reduced brain synaptophysin levels in aged rats to those in young rats. Our findings support the idea that partial inhibition of BACE1 by TAK-070 exerts symptomatic as well as disease-modifying effects for the treatment of Alzheimer's disease.
MeSH term(s)	Administration, Oral ; Aging/drug effects ; Aging/metabolism ; Aging/psychology ; Amyloid Precursor Protein Secretases/antagonists & inhibitors ; Amyloid beta-Peptides/metabolism ; Animals ; Biphenyl Compounds/administration & dosage ; Biphenyl Compounds/pharmacology ; Brain/drug effects ; Brain/metabolism ; Cerebral Cortex/drug effects ; Cerebral Cortex/metabolism ; Dose-Response Relationship, Drug ; Enzyme-Linked Immunosorbent Assay ; Male ; Maze Learning/drug effects ; Naphthalenes/administration & dosage ; Naphthalenes/pharmacology ; Neuropsychological Tests ; Peptide Fragments/metabolism ; Rats ; Rats, Inbred F344 ; Rats, Wistar ; Spatial Behavior/drug effects ; Swimming ; Synaptophysin/metabolism ; Treatment Outcome
Chemical Substances	Amyloid beta-Peptides ; Biphenyl Compounds ; Naphthalenes ; Peptide Fragments ; Synaptophysin ; TAK-070 ; amyloid beta-protein (1-40) ; amyloid beta-protein (1-42) ; Amyloid Precursor Protein Secretases (EC 3.4.-)
Language	English
Publishing date	2010-11-18
Publishing country	Netherlands
Document type	Journal Article
ZDB-ID	1200-2
ISSN	1872-6240 ; 0006-8993
ISSN (online)	1872-6240
ISSN	0006-8993
DOI	10.1016/j.brainres.2010.09.032
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