Publications by authors named "F P Vanhoutte"
Evaluating the pharmacokinetics of beclometasone dipropionate/formoterol fumarate/glycopyrronium bromide delivered via pressurised metered-dose inhaler using a low global warming potential propellant.
Pulm Pharmacol Ther
June 2024
Article Synopsis
- The text discusses the transition from high global warming potential propellants in metered-dose inhalers (MDIs) to those with lower environmental impact, specifically investigating a new formulation of BDP/FF/GB using HFA-152a instead of HFA-134a.
- Three studies were conducted to compare the pharmacokinetics of the new formulation, focusing on metrics like lung availability and systemic exposure in healthy volunteers, using a crossover design.
- Results showed that bioequivalence was achieved for systemic exposure of the active ingredients in most cases, but not for one measurement of glycopyrronium bromide, indicating some variability in absorption.
Mibavademab (previously known as REGN4461), a fully human monoclonal antibody, is being investigated for the treatment of conditions associated with leptin deficiency. Here, we report pharmacokinetics (PKs), pharmacodynamics, and immunogenicity from a phase I study in healthy participants (NCT03530514). In part A, lean or overweight healthy participants were randomized to single-ascending-dose cohorts of 0.
View Article and Find Full Text PDFPurpose: Consistency in delineation of pelvic lymph node regions for prostate cancer elective nodal radiation therapy is still challenging despite current guidelines. The aim of this study was to evaluate the interobserver variability in elective lymph node delineation in the PEACE V STORM randomized phase 2 trial for oligorecurrent nodal prostate cancer.
Methods And Materials: Twenty-three centers were asked to delineate the elective pelvic nodal clinical target volume (CTV) of a postoperative oligorecurrent nodal prostate cancer benchmark case using a modified Radiation Therapy Oncology Group (RTOG) 2009 template (upper limit at the L4/L5 interspace).
Background: Dengue is a growing global health threat with no specific antiviral drugs available for treatment or prophylaxis. This first-in-human, double-blind, randomized, placebo-controlled study aimed to examine the safety, tolerability, and pharmacokinetics of increasing single and multiple oral doses of JNJ-1802, a pan-serotype dengue antiviral small molecule.
Methods: Eligible healthy participants (18-55 years of age) were randomized to receive oral JNJ-1802 in fasted conditions as (1) single doses (50-1200 mg; n = 29) or placebo (n = 10); or (2) once-daily doses (50-560 mg for 10 consecutive days or 400 mg for 31 days; n = 38) or placebo (n = 9).
Article Synopsis
- MK-0616 is a newly developed oral PCSK9 inhibitor that raises hope for an alternative to injectable treatments, following nearly 20 years of research without an effective oral option.* -
- Using advanced mRNA display screening and structured drug design, MK-0616 was shown to effectively lower PCSK9 levels and significantly reduce LDL cholesterol in clinical trials.* -
- The trials indicated that MK-0616 has a strong affinity for PCSK9 and demonstrated promising safety and efficacy, suggesting it could be a game changer in cholesterol management.*