Explanipedia

Clinical proof-of-concept results with a novel TRPA1 antagonist (LY3526318) in 3 chronic pain states Open

Marcia Lagarde, Darren Wilbraham, Ricardo Fonseca Martins, Haitao Zhao, Kimberley Jackson , et al. · 2024

Transient receptor potential ankyrin 1 (TRPA1) is implicated in physiological and pathological nociceptive signaling, but the clinical benefit of TRPA1 antagonists in chronic pain is not clearly demonstrated. LY3526318 is an oral, potent, …

Studies to Assess the Utility of Serum Neurofilament Light Chain as a Biomarker in Chemotherapy-Induced Peripheral Neuropathy Open

Guido Cavaletti, Chiara Pizzamiglio, Albert Man, Thomas M. Engber, Cristoforo Comi , et al. · 2023

Chemotherapy-induced peripheral neuropathy (CIPN) is one of the most common and disabling dose-limiting toxicities of chemotherapy. We report here the results of two separate non-interventional studies (49 patients), which evaluated blood …

Safety, Tolerability, and Pharmacokinetics of Mevidalen (LY3154207), a Centrally Acting Dopamine D1 Receptor–Positive Allosteric Modulator, in Patients With Parkinson Disease Open

Darren Wilbraham, Kevin Biglan, Kjell Svensson, Max Tsai, Melissa Pugh , et al. · 2021

Mevidalen (LY3154207) is a positive allosteric modulator of the dopamine D1 receptor that enhances the affinity of dopamine for the D1 receptor. The safety, tolerability, motor effects, and pharmacokinetics of mevidalen were studied in pat…

Pharmacokinetics, Safety, and Tolerability of Lasmiditan in Pediatric Patients with Migraine Open

Max Tsai, Emel Serap Monkul Nery, Lisa Kerr, Rashna Khanna, Mika Komori , et al. · 2021

The PK results support weight-based dosing of lasmiditan in pediatric patients with migraine and no new safety or tolerability issues were identified. These findings support further investigation of lasmiditan as a potential treatment in p…

Safety, Tolerability, and Pharmacokinetics of Mevidalen (LY3154207), a Centrally Acting Dopamine D1 Receptor‐Positive Allosteric Modulator (D1PAM), in Healthy Subjects Open

Darren Wilbraham, Kevin Biglan, Kjell Svensson, Max Tsai, William Kielbasa · 2020

Activation of the brain dopamine D1 receptor has attracted attention because of its promising role in neuropsychiatric diseases. Although efforts to develop D1 agonists have been challenging, a positive allosteric modulator (PAM), represen…

Issue Information Open

Jeroen Roosendaal, Hilde Rosing, Jos H. Beijnen, Mohammad Hossain, Courtney Tiffany , et al. · 2020

Clinical Pharmacology in Drug Development is an international, peer-reviewed journal focused on publishing high-quality clinical pharmacology studies which are primarily (but not exclusively) performed in healthy volunteers during the earl…

Safety, Tolerability, and Pharmacokinetics of Lasmiditan in Healthy Japanese and Caucasian Subjects Open

Mika Komori, Hanaka Mimura, Max Tsai, Akichika Ozeki, Takaichi Go , et al. · 2020

Objective: This is the first clinical study in Japanese healthy subjects to assess the safety, tolerability, and pharmacokinetics of lasmiditan, a selective serotonin 5-HT1F receptor agonist being developed for the acute treatment of migra…

Effects of lasmiditan on simulated driving performance: Results of two randomized, blinded, crossover studies with placebo and active controls Open

Eric Pearlman, Darren Wilbraham, Ellen B. Dennehy, Paul H. Berg, Max Tsai , et al. · 2020

Objective To evaluate the impact of lasmiditan, an oral, centrally‐penetrant, selective serotonin 1F (5‐HT 1F ) receptor agonist developed for the acute treatment of migraine, on simulated driving. Methods Healthy adult volunteers enrolled…

Issue Information Open

Meilin Liu, Aniwaa Owusu Obeng, J Gréger, Vernice Bates, Laszlo Mechtler , et al. · 2020

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…

Effects of Lasmiditan on Cardiovascular Parameters and Pharmacokinetics in Healthy Subjects Receiving Oral Doses of Propranolol Open

Max Tsai, Michael Case, Paul Ardayfio, Helen Hochstetler, Darren Wilbraham · 2020

Lasmiditan (LY573144/COL‐144) is a high‐affinity, centrally penetrant, selective 5‐HT 1F receptor agonist currently under investigation for acute treatment of migraine. Although lasmiditan is not known to induce vasoconstriction, it remain…

Abuse Potential of Lasmiditan: A Phase 1 Randomized, Placebo‐ and Alprazolam‐Controlled Crossover Study Open

Darren Wilbraham, Paul H. Berg, Max Tsai, Emily Liffick, Li Shen Loo , et al. · 2019

Lasmiditan is a centrally penetrant, highly selective 5‐hydroxytryptamine (serotonin) receptor 1F (5HT 1F ) agonist under development as a novel therapy for acute treatment of migraine. A phase 1 randomized, placebo‐ and positive‐controlle…

Pharmacokinetics, Pharmacodynamics, Tolerability, and Food Effect of Cenerimod, a Selective S1P1 Receptor Modulator in Healthy Subjects Open

Pierre‐Éric Juif, Daniela Baldoni, Maribel Reyes, Darren Wilbraham, Salvatore Febbraro , et al. · 2017

The pharmacokinetics, pharmacodynamics, tolerability, and food effect of cenerimod, a potent sphingosine-1-phosphate subtype 1 receptor modulator, were investigated in three sub-studies. Two double-blind, placebo-controlled, randomised stu…

Cardiac effects of amiselimod compared with fingolimod and placebo: results of a randomised, parallel‐group, phase I study in healthy subjects Open

Tomohiko Harada, Darren Wilbraham, Guillemette de La Borderie, Shinsuke Inoue, Jim Bush , et al. · 2016

Aim Amiselimod (MT‐1303) is a selective sphingosine 1‐phosphate 1 (S1P 1 ) receptor modulator which is currently being developed for the treatment of various autoimmune diseases. Unlike some other S1P receptor modulators, amiselimod seemed…

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