Results 181 to 190 of about 728,357 (259)

Clinical Evaluation of Potential Interaction Between Bemnifosbuvir and Ruzasvir With an Assessment of Food Effect: Results of a Phase 1 Study in Healthy Participants

Clinical Pharmacology in Drug Development, EarlyView.
Abstract A combination of nucleotide hepatitis C virus (HCV) nonstructural protein (NS) 5B and 5A inhibitors is a preferred standard of care for treating chronic HCV. Bemnifosbuvir is a novel oral guanosine nucleotide prodrug with potent pan‐genotypic inhibitory activity against HCV NS5B.
Xiao‐Jian Zhou, Gaetano Morelli, Maureen Montrond, Shannan Lynch, Keith Pietropaolo, Bruce Belanger, Arantxa Horga, Janet Hammond   +7 more
wiley   +1 more source

Measuring the placebo effect in carpal tunnel syndrome. [PDF]

J Orthop Traumatol, 2020
Faig-Martí J, Martínez-Catassús A.
europepmc   +1 more source

A Randomized Thorough QT Trial Using Concentration‐QT Analysis to Evaluate the Effects of Centanafadine on Cardiac Repolarization

Clinical Pharmacology in Drug Development, EarlyView.
Abstract Centanafadine is a norepinephrine/dopamine/serotonin reuptake inhibitor in development for treatment of attention‐deficit/hyperactivity disorder. This double‐blind, placebo‐ and moxifloxacin‐controlled, 3‐period crossover trial evaluated the effects of centanafadine (EB‐1020) and its metabolite (EB‐10601) on cardiac repolarization in 30 ...
Osman S. Turkoglu, Xiaofeng Wang, Jennifer Repella‐Gordon, Susan E. Shoaf   +3 more
wiley   +1 more source

A 2‐Part, Open‐Label, Phase 1 Bioequivalence and Food‐Effect Study of Ubrogepant in Healthy Adult Participants

Clinical Pharmacology in Drug Development, EarlyView.
Abstract This Phase 1 study of ubrogepant was conducted to establish the bioequivalence (BE) of the 50‐ and 100‐mg to‐be‐marketed (TBM) tablet formulations with the clinical trial (CT) 100‐mg tablet formulation and evaluate the food effect on the bioavailability of the 100‐mg TBM tablet. This 2‐part study enrolled healthy participants aged 18‐45 years.
Ramesh Boinpally, Joel M. Trugman
wiley   +1 more source

Impact of Model‐Informed Drug Development on Drug Development Cycle Times and Clinical Trial Cost

Clinical Pharmacology &Therapeutics, EarlyView.
Model‐informed drug development (MIDD) integrates data to quantify benefit/risk informing objective drug discovery and development decisions. An additional critical benefit of MIDD is postulated to be improvement in trial and program efficiencies. While the application of MIDD has grown, there have been no clear examples across programs to demonstrate ...
Vaishali Sahasrabudhe, Timothy Nicholas, Gianluca Nucci, Cynthia J Musante, Brian Corrigan   +4 more
wiley   +1 more source

First‐in‐Human Single and Multiple Ascending Dose Studies of Balinatunfib, a Small Molecule Inhibitor of TNFR1 Signaling in Healthy Participants

Clinical Pharmacology &Therapeutics, EarlyView.
Oral small molecule inhibitors of tumor necrosis factor alpha (TNFα) are emerging as attractive therapeutic agents for the treatment of various autoimmune diseases. Balinatunfib (SAR441566), a novel oral inhibitor of tumor necrosis factor receptor 1 (TNFR1) signaling, changes the configuration of the soluble TNFα (sTNFα) trimer and prevents its ...
Nassr Nassr, Faiza Rharbaoui, Dietmar Weitz, Johann Gassenhuber, Markus Rehberg, Markus Kohlmann, Fabienne Schumacher, Amel Lahmar, Andreas Kovar, Laurent Perrin, Frank‐Dietrich Wagner, Maria Wiekowski, Mai Anh Nguyen   +12 more
wiley   +1 more source

Supplementing Single‐Arm Trials with External Control Arms—Evaluation of German Real‐World Data

Clinical Pharmacology &Therapeutics, EarlyView.
As single‐arm trials (SATs) are increasingly used in pharmaceutical research, the validity of such study designs needs to be critically assessed. We characterize the feasibility of supplementing SATs with real‐world data (RWD)‐derived external control arms by determining the proportion of SATs on breast cancer and amyotrophic lateral sclerosis (ALS ...
Martin Russek, Jonas Peltner, Britta Haenisch   +2 more
wiley   +1 more source

Confirmation of Fixed Quarterly Riliprubart Regimen in Patients with Cold Agglutinin Disease Using Population PK/PD and Exposure‐Response Analyses

Clinical Pharmacology &Therapeutics, EarlyView.
Riliprubart is a second‐generation, humanized immunoglobulin G4 that inhibits only the activated form of the C1s component of the proximal classical complement pathway. The clinical studies of riliprubart conducted thus far for the treatment of cold agglutinin disease (CAD), a rare autoimmune disease, include a Phase 1 first‐in‐human study in healthy ...
Timothy Chow, Marek Wardecki, Michael Storek, Nancy Wong   +3 more
wiley   +1 more source

Prevalence of Actionable Pharmacogenetic Genotype Frequencies, Cautionary Medication Use, and Polypharmacy in Community‐Dwelling Older Adults

Clinical Pharmacology &Therapeutics, EarlyView.
Older adults (65 years and over) frequently manage complex medication regimens and are vulnerable to adverse drug reactions and treatment inefficacies, some of which could be preventable with pharmacogenetics (PGx)‐guided prescribing. This study examined the prevalence of actionable PGx genotypes (i.e., those linked to a guideline that recommends a ...
Chad A. Bousman, Ankita Narang, Ziad Al Bkhetan, Robyn L. Woods, Suzanne G. Orchard, Alice J. Owen, Michelle A. Fravel, Julia Gilmartin‐Thomas, Joanne Ryan, Peter D. Fransquet, Rory Wolfe, Chenglong Yu, John J. McNeil, Paul Lacaze, Michael E. Ernst   +14 more
wiley   +1 more source

Dose Optimization in Oncology Drug Development: Risk Factors for Postmarketing Requirements and Commitments

Clinical Pharmacology &Therapeutics, EarlyView.
Optimal dosing of oncological drugs is historically determined based on the “higher is better” paradigm. However, a paradigm shift in optimal dose selection has occurred in the development of new modalities, including molecularly targeted drugs, antibody drugs, and immunotherapies.
Hiroe Kitagaki, Kentaro Takeda, Kazuya Murai, Hideki Maeda   +3 more
wiley   +1 more source