Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Muscarinic M

ASP8302 muscarinic M3 receptor pharmacodynamics pharmacokinetics positive allosteric modulator salivary secretion

Journal

Clinical pharmacology in drug development
ISSN: 2160-7648
Titre abrégé: Clin Pharmacol Drug Dev
Pays: United States
ID NLM: 101572899

Informations de publication

Date de publication:
09 Aug 2024
Historique:
received: 22 03 2024
accepted: 15 07 2024
medline: 9 8 2024
pubmed: 9 8 2024
entrez: 9 8 2024
Statut: aheadofprint

Résumé

ASP8302 is an orally administered positive allosteric modulator of the muscarinic M

Identifiants

pubmed: 39120583
doi: 10.1002/cpdd.1460
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Informations de copyright

© 2024 Astellas Pharma Inc, Clinical Pharmacology in Drug Development published by Wiley Periodicals LLC on behalf of American College of Clinical Pharmacology.

Références

Wess J, Duttaroy A, Zhang W, et al. M1‐M5 muscarinic receptor knockout mice as novel tools to study the physiological roles of the muscarinic cholinergic system. Recept Channels. 2003;9(4):279‐290.
Pakala RS, Brown KN, Preuss CV. Cholinergic Medications. StatPearls Publishing; 2022. https://www.ncbi.nlm.nih.gov/books/NBK538163/
Dror RO, Green HF, Valant C, et al. Structural basis for modulation of a G‐protein‐coupled receptor by allosteric drugs. Nature. 2013;503:295‐299.
Kruse AC, Ring AM, Manglik A, et al. Activation and allosteric modulation of a muscarinic acetylcholine receptor. Nature. 2013;504:101‐106.
Okimoto R, Ino K, Ishizu K, et al. Potentiation of muscarinic M3 receptor activation through a new allosteric site with a novel positive allosteric modulator ASP8302. J Pharmacol Exp Ther. 2021;379(1):64‐73.
Okimoto R, Ino K, Ishizu K, et al. Muscarinic M3 positive allosteric modulator ASP8302 enhances bladder contraction and improves voiding dysfunction in rats. Low Urin Tract Symptoms. 2022;14(4):289‐300.
van Till JWO, Arita E, Kuroishi K, et al. Muscarinic‐3‐receptor positive allosteric modulator ASP8302 in patients with underactive bladder. A randomized controlled trial. Neurourol Urodyn. 2022;41(5):1139‐1148.
Wess J, Eglen RM, Gautam D. Muscarinic acetylchoine recepors: mutant mice provide new insights for drug development. Nat Rev Drug Discov. 2007;6(9):721‐733.
Araya R, Noguchi T, Yuhki M, et al. Loss of M5 muscarinic acetylcholine receptors leads to cerebrovascular and neuronal abnormalities and cognitive deficits in mice. Neurobiol Dis. 2006;24(2):334‐344.
Zhang W, Yamada M, Gomeza J, Basile AS, Wess J. Multiple muscarinic acetylcholine receptor subtypes modulate striatal dopamine release, as studied with M1‐M5 muscarinic receptor knock‐out mice. J Neurosci. 2002;22(15):6347‐6352.
EMA Committee for Medicinal Products for Human Use (CHMP). Guideline on Strategies to Identify and Mitigate Risks for First‐in‐Human and Early Clinical Trials with Investigational Medicinal Products. EMEA/CHMP/SWP/28367/07 Rev. 1. July 20, 2017.
Gabelt BT, Kaufman PL. Inhibition of aceclidine‐stimulated outflow facility, accommodation and miosis in rhesus monkeys by muscarinic receptor subtype antagonists. Exp Eye Res. 1994;58(5):623‐630.
Epstein JB, Burchell JL, Emerton S, Le ND, Silverman S Jr. A clinical trial of bethanechol in patients with xerostomia after radiation therapy. A pilot study. Oral Surg Oral Med Oral Pathol. 1994;77(6):610‐614.
Treijtel N, Groenendaal‐van de Meent D, Michon I, et al. Pilocarpine‐induced effects on salivary secretion as a pharmacological biomarker for cholinergic parasympathetic activation. Clin Pharmacol Drug Dev. 2022;11(1):25‐33.
Cleveland WS. Robust locally weighted regression and smoothing scatterplots. J Am Stat Assoc. 1979;74:829‐836.
Cleveland WS. LOWESS: a program for smoothing scatterplots by robust locally weighted regression. Am Stat. 1981;35:54.
Ehlert FJ, Pak KJ, Griffin MT. Muscarinic agonists and antagonists: effects on gastrointestinal function. Handb Exp Pharmacol. 2012;(208):343‐374.
Zanger UM, Schwab M. Cytochrome P450 enzymes in drug metabolism: regulation of gene expression, enzyme activities, and impact of genetic variation. Pharmacol Ther. 2013;138(1):103‐141.
Xu F, Laguna L, Sarkar A. Aging‐related changes in quantity and quality of saliva: where do we stand in our understanding? J Texture Stud. 2019;50(1):27‐35.

Auteurs

Shin Takusagawa (S)

Astellas Pharma Inc., Tokyo, Japan.

Nicoline Treijtel (N)

Astellas Pharma Europe B.V., Leiden, The Netherlands.

Masako Saito (M)

Astellas Pharma Inc., Tokyo, Japan.

Ingrid Michon (I)

Astellas Pharma Europe B.V., Leiden, The Netherlands.

Daisuke Miyatake (D)

Astellas Pharma Inc., Tokyo, Japan.

Fumio Osaki (F)

Astellas Pharma Inc., Tokyo, Japan.

Sayuri Guro (S)

Astellas Pharma Inc., Tokyo, Japan.

Tomasso Fadini (T)

PAREXEL International, Berlin, Germany.

Hisakuni Sekino (H)

Sekino Clinical Pharmacology Clinic, Tokyo, Japan.

Marlous Aarden-Bakker (M)

Astellas Pharma Europe B.V., Leiden, The Netherlands.

Kentaro Kuroishi (K)

Astellas Pharma Inc., Tokyo, Japan.

Jan Willem Olivier van Till (JWO)

Mitobridge Inc., Cambridge, MA, USA.

Dorien Groenendaal-van de Meent (D)

Astellas Pharma Europe B.V., Leiden, The Netherlands.

Michiel de Vries (M)

Astellas Pharma Europe B.V., Leiden, The Netherlands.

Classifications MeSH