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  1. Article ; Online: Pharmacokinetics, Pharmacodynamics, and Safety of Evocalcet (KHK7580), a Novel Calcimimetic Agent: An Open-Label, Single- and Multiple-Dose, Phase I Trial in Healthy Chinese Subjects.

    He, Xuemei / Narushima, Kazuya / Kojima, Masahiro / Nagai, Chisato / Li, Kexin

    Drug design, development and therapy

    2024  Volume 18, Page(s) 567–581

    Abstract: Purpose: This study explored the pharmacokinetics (PK), pharmacodynamics (PD), and safety of evocalcet (KHK7580), a new calcimimetic agent, in healthy Chinese subjects following single and multiple doses.: Methods: This was a single-center, open- ... ...

    Abstract Purpose: This study explored the pharmacokinetics (PK), pharmacodynamics (PD), and safety of evocalcet (KHK7580), a new calcimimetic agent, in healthy Chinese subjects following single and multiple doses.
    Methods: This was a single-center, open-label phase I trial conducted in China. The study started from the single-dose cohorts (1, 3, 6, 12 mg evocalcet, step-by-step administration) and proceeded to the multiple-dose cohort (6 mg evocalcet once daily for eight days). Blood and urine samples were collected at the designated time points for pharmacokinetic and pharmacodynamic analysis. Safety was evaluated by treatment-emergent adverse events (TEAEs), clinical laboratory tests, vital signs, electrocardiograms (ECGs), and ophthalmological examination.
    Results: Among 42 enrolled subjects, eight in each single-dose cohort and 10 in multiple-dose cohort, 40 subjects completed the study. In single-dose cohorts, t
    Conclusion: In healthy Chinese subjects, evocalcet demonstrated dose-dependent PK and PD properties and was well-tolerated.
    MeSH term(s) Humans ; Naphthalenes ; Pyrrolidines ; Asian People ; Calcimimetic Agents ; China
    Chemical Substances evocalcet (E58MLH082P) ; Naphthalenes ; Pyrrolidines ; Calcimimetic Agents
    Language English
    Publishing date 2024-02-26
    Publishing country New Zealand
    Document type Clinical Trial, Phase I ; Case Reports ; Clinical Trial
    ZDB-ID 2451346-5
    ISSN 1177-8881 ; 1177-8881
    ISSN (online) 1177-8881
    ISSN 1177-8881
    DOI 10.2147/DDDT.S437903
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article ; Online: Comparison of the Oral Calcimimetics Evocalcet and Cinacalcet in East Asian Patients on Hemodialysis with Secondary Hyperparathyroidism.

    Ni, Zhaohui / Liang, Xinling / Wu, Chia-Chao / Jin, Kyubok / Kim, Yong-Lim / Lu, Kuo-Cheng / Chan, Tak Mao / Fukagawa, Masafumi / Kinoshita, Jun / Nagai, Chisato / Kojima, Masahiro / Yu, Xueqing

    Kidney international reports

    2023  Volume 8, Issue 11, Page(s) 2294–2306

    Abstract: Introduction: Evocalcet is an oral calcimimetic agent with proven efficacy and safety in treating secondary hyperparathyroidism (SHPT) in Japanese patients on dialysis.: Methods: This randomized, double-blind, intrapatient dose-adjustment, parallel- ... ...

    Abstract Introduction: Evocalcet is an oral calcimimetic agent with proven efficacy and safety in treating secondary hyperparathyroidism (SHPT) in Japanese patients on dialysis.
    Methods: This randomized, double-blind, intrapatient dose-adjustment, parallel-group, international multicenter study compared the efficacy and safety of evocalcet versus cinacalcet for 52 weeks in East Asian hemodialysis patients with SHPT.
    Results: In total, 203 and 200 patients were randomized to receive evocalcet or cinacalcet, respectively (overall, 70.1% had baseline intact parathyroid hormone (PTH) levels ≥500 pg/ml, with no between-group difference). Mean percentage changes in intact PTH levels from baseline were -34.7% and -30.2% in the evocalcet and cinacalcet groups at 52 weeks (between-group difference -4.4%, 95% confidence interval [CI] -13.1%, 4.3%, below the predefined 15% noninferiority margin). Overall, 67.3% and 58.7% of patients in the evocalcet and cinacalcet groups, respectively, achieved ≥30% decrease in intact PTH levels from baseline (between-group difference 8.6%; 95% CI -1.8%, 19.1%). No major safety concerns were observed. Gastrointestinal adverse events (AEs) were significantly less frequent with evocalcet compared with cinacalcet (33.5% vs. 50.5%,
    Conclusion: Evocalcet might be a better alternative to cinacalcet for East Asian patients on hemodialysis with SHPT.
    Language English
    Publishing date 2023-08-29
    Publishing country United States
    Document type Journal Article
    ISSN 2468-0249
    ISSN (online) 2468-0249
    DOI 10.1016/j.ekir.2023.08.034
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  3. Article ; Online: Intracellular stability of 2'-OMe-4'-thioribonucleoside modified siRNA leads to long-term RNAi effect.

    Takahashi, Mayumi / Nagai, Chisato / Hatakeyama, Hiroto / Minakawa, Noriaki / Harashima, Hideyoshi / Matsuda, Akira

    Nucleic acids research

    2012  Volume 40, Issue 12, Page(s) 5787–5793

    Abstract: Chemically modified siRNAs are expected to have resistance toward nuclease degradation and good thermal stability in duplex formation for in vivo applications. We have recently found that 2'-OMe-4'-thioRNA, a hybrid chemical modification based on 2'- ... ...

    Abstract Chemically modified siRNAs are expected to have resistance toward nuclease degradation and good thermal stability in duplex formation for in vivo applications. We have recently found that 2'-OMe-4'-thioRNA, a hybrid chemical modification based on 2'-OMeRNA and 4'-thioRNA, has high hybridization affinity for complementary RNA and significant resistance toward degradation in human plasma. These results prompted us to develop chemically modified siRNAs using 2'-OMe-4'-thioribonucleosides for therapeutic application. Effective modification patterns were screened with a luciferase reporter assay. The best modification pattern of siRNA, which conferred duration of the gene-silencing effect without loss of RNAi activity, was identified. Quantification of the remaining siRNA in HeLa-luc cells using a Heat-in-Triton (HIT) qRT-PCR revealed that the intracellular stability of the siRNA modified with 2'-OMe-4'-thioribonucleosides contributed significantly to the duration of its RNAi activity.
    MeSH term(s) Genes, Reporter ; HeLa Cells ; Humans ; Luciferases, Firefly/genetics ; RNA Interference ; RNA Stability ; RNA, Small Interfering/chemistry ; RNA, Small Interfering/metabolism ; Ribonucleases/metabolism ; Ribonucleosides/chemistry ; Thionucleosides/chemistry
    Chemical Substances RNA, Small Interfering ; Ribonucleosides ; Thionucleosides ; Luciferases, Firefly (EC 1.13.12.7) ; Ribonucleases (EC 3.1.-)
    Language English
    Publishing date 2012-03-12
    Publishing country England
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 186809-3
    ISSN 1362-4962 ; 1362-4954 ; 0301-5610 ; 0305-1048
    ISSN (online) 1362-4962 ; 1362-4954
    ISSN 0301-5610 ; 0305-1048
    DOI 10.1093/nar/gks204
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    In stock of ZB MED Cologne/Königswinter

    Zs.A 1067: Show issues Location:
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    Jg. 1995 - 2021: Lesesall (1.OG)
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  4. Article ; Online: Synthesis, structure, and biological activity of dumbbell-shaped nanocircular RNAs for RNA interference.

    Abe, Naoko / Abe, Hiroshi / Nagai, Chisato / Harada, Mitsuru / Hatakeyama, Hiroto / Harashima, Hideyoshi / Ohshiro, Takahito / Nishihara, Mizuki / Furukawa, Kazuhiro / Maeda, Mizuo / Tsuneda, Satoshi / Ito, Yoshihiro

    Bioconjugate chemistry

    2011  Volume 22, Issue 10, Page(s) 2082–2092

    Abstract: RNA interference (RNAi) is one of the most promising new approaches for disease therapy. The design of a dumbbell-shaped nanocircular RNA allows it to act as a short interfering RNA (siRNA) precursor. To optimize the design, we studied the relationship ... ...

    Abstract RNA interference (RNAi) is one of the most promising new approaches for disease therapy. The design of a dumbbell-shaped nanocircular RNA allows it to act as a short interfering RNA (siRNA) precursor. To optimize the design, we studied the relationship between the nanostructure and RNAi activity by synthesizing various RNA dumbbells. An RNA dumbbell with a 23-bp stem and 9-nt loops was the most potent. Sequence analysis by mass spectrometry showed that Dicer could edit RNA dumbbells to siRNA species. The reaction offered the slow release of siRNA species, which conferred prolonged RNAi activity. Introduction of DNA into the loop position significantly stabilized the dumbbell in biological fluid without any loss of RNAi activity. In-depth pharmacological evaluation was performed by introducing dumbbells into HeLa cells that stably express the target luciferase gene. The dumbbells provided a rapid silencing effect and retained this effect for a longer time even at a lower concentration than that at which standard siRNA completely lost RNAi activity. We conclude that an RNA dumbbell with DNA loops is the most promising design for in vivo applications for RNA medicine.
    MeSH term(s) Animals ; Base Sequence ; Cell Line ; HeLa Cells ; Humans ; Mice ; Molecular Sequence Data ; NIH 3T3 Cells ; Nanostructures/chemistry ; Nucleic Acid Conformation ; RNA/chemistry ; RNA/genetics ; RNA/metabolism ; RNA Interference ; RNA Stability ; RNA, Small Interfering/genetics ; RNA, Small Interfering/metabolism ; Ribonuclease III/metabolism
    Chemical Substances RNA, Small Interfering ; RNA (63231-63-0) ; Ribonuclease III (EC 3.1.26.3)
    Language English
    Publishing date 2011-10-19
    Publishing country United States
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 1024041-x
    ISSN 1520-4812 ; 1043-1802
    ISSN (online) 1520-4812
    ISSN 1043-1802
    DOI 10.1021/bc2003154
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    In stock of ZB MED Cologne/Königswinter

    Zs.A 3400: Show issues Location:
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