Population Pharmacokinetic/Pharmacodynamic Modeling of the Effect of Abrocitinib on QT Intervals in Healthy Volunteers
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DOI: 10.1002/cpdd.1111
Abstract: Abrocitinib is a selective Janus kinase 1 inhibitor for the treatment of moderate to severe atopic dermatitis (AD). To assess the relationship between abrocitinib plasma concentrations and heart rate (HR)–corrected QT (QTc) and HR and… read more here.
Keywords: effect abrocitinib; healthy volunteers; effect; population pharmacokinetic ... See more keywords
Comparative Bioavailability of a Single Dose of Trametinib (TMT212) Containing 9% vs 11% Dimethyl Sulfoxide in Randomized Healthy Volunteers to Assess Long‐Term Storage at Room Temperature
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DOI: 10.1002/cpdd.1129
Abstract: Storage of trametinib tablets outside of 2‐8°C protected from moisture may lead to loss of dimethyl sulfoxide (DMSO) and adversely impact trametinib bioavailability. In this open‐label, phase 1, single‐dose, randomized, 2‐treatment, 2‐period crossover study in… read more here.
Keywords: single dose; healthy volunteers; bioavailability; trametinib ... See more keywords
Pharmacokinetics and Safety Study of HN0037, a Novel Anti‐Human Herpes Simplex Virus Inhibitor, in Healthy Volunteers
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DOI: 10.1002/cpdd.1138
Abstract: HN0037 is a helicase‐primase inhibitor developed to treat herpes simplex virus (HSV) infection. This study evaluated the safety, tolerability, and pharmacokinetics of HN0037, following oral administration in healthy volunteers. This double‐blind, placebo‐controlled, phase 1 study… read more here.
Keywords: healthy volunteers; simplex virus; inhibitor; study ... See more keywords
Population Pharmacokinetics of Oral Brepocitinib in Healthy Volunteers and Patients
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DOI: 10.1002/cpdd.1163
Abstract: Brepocitinib is a tyrosine kinase 2 and Janus kinase 1 inhibitor in development for treatment of inflammatory autoimmune diseases. This analysis aimed to add to the pharmacokinetic knowledge of the medication, through development of a… read more here.
Keywords: volunteers patients; healthy volunteers; brepocitinib; model ... See more keywords
Amenamevir: Studies of Potential CYP3A‐Mediated Pharmacokinetic Interactions With Midazolam, Cyclosporine, and Ritonavir in Healthy Volunteers
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DOI: 10.1002/cpdd.586
Abstract: Amenamevir (formerly ASP2151) is a helicase‐primase inhibitor being developed for the treatment of herpesvirus infection. Amenamevir is both a substrate and inducer of cytochrome P450 (CYP) 3A4. Three studies were done in healthy volunteers to… read more here.
Keywords: cyp3a mediated; cyp3a; healthy volunteers; geometric mean ... See more keywords
Randomized Phase I Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Topical Daprodustat in Healthy Volunteers and in Patients With Diabetic Foot Ulcers
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DOI: 10.1002/cpdd.654
Abstract: Daprodustat, a small‐molecule inhibitor of prolyl hydroxylases, prevents breakdown of hypoxia‐inducible factor (HIF), leading to increased transcription of HIF‐responsive genes. This randomized, placebo‐controlled study evaluated the safety, tolerability, and pharmacokinetics of a topical formulation of… read more here.
Keywords: daprodustat; safety tolerability; safety; healthy volunteers ... See more keywords
Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Oral Venglustat in Healthy Volunteers
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DOI: 10.1002/cpdd.865
Abstract: Venglustat is a small‐molecule glucosylceramide synthase (GCS) inhibitor designed to reduce the production of glucosylceramide (GL‐1) and thus is expected to substantially reduce formation of glucosylceramide‐based glycosphingolipids. Because of its effect on glycosphingolipid formation, GCS… read more here.
Keywords: safety tolerability; safety; healthy volunteers; pharmacokinetics pharmacodynamics ... See more keywords
Detection of erythropoiesis stimulating agent Luspatercept after administration to healthy volunteers for antidoping purposes
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DOI: 10.1002/dta.3341
Abstract: Abstract Luspatercept (Reblozyl®) is a newly approved anti‐anemic drug prohibited by the World Anti‐Doping Agency. It promotes erythropoiesis by limiting apoptosis of immature erythroblasts and the risk of misuse by athletes for doping is high.… read more here.
Keywords: volunteers antidoping; administration; healthy volunteers; erythropoiesis stimulating ... See more keywords
Nonlinear Population Pharmacokinetics of Anifrolumab in Healthy Volunteers and Patients With Systemic Lupus Erythematosus
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DOI: 10.1002/jcph.2055
Abstract: We characterized the population pharmacokinetics of anifrolumab, a type I interferon receptor–blocking antibody. Pharmacokinetic data were analyzed from the anifrolumab (intravenous [IV], every 4 weeks) arms from 5 clinical trials in patients with systemic lupus… read more here.
Keywords: pharmacokinetics anifrolumab; healthy volunteers; patients systemic; population pharmacokinetics ... See more keywords
PRT062607 Achieves Complete Inhibition of the Spleen Tyrosine Kinase at Tolerated Exposures Following Oral Dosing in Healthy Volunteers
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DOI: 10.1002/jcph.794
Abstract: The spleen tyrosine kinase (SYK) regulates immune cell activation in response to engagement of a variety of receptors, making it an intriguing target for the treatment of inflammatory and autoimmune disorders as well as certain… read more here.
Keywords: kinase; inhibition; healthy volunteers; spleen tyrosine ... See more keywords
A Systematic Review and Pooled Analysis of Select Safety Parameters Among Normal Healthy Volunteers Taking Placebo in Phase 1 Clinical Trials
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DOI: 10.1002/jcph.913
Abstract: A systematic review of the Bristol‐Myers Squibb normal healthy volunteers (NHVs) database identified phase 1 trials that included NHVs administered placebo with the aim of characterizing normal inter‐ and intraindividual safety parameter variability. Twenty‐five single… read more here.
Keywords: phase; normal healthy; analysis; systematic review ... See more keywords