Clinical Pharmacology in Drug Development

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Single‐ and Multiple‐Day Dosing Studies to Investigate High‐Dose Pharmacokinetics of Epelsiban and Its Metabolite, GSK2395448, in Healthy Female Volunteers
Clinical Pharmacology in Drug Development - Tập 7 Số 1 - Trang 33-43 - 2018
Kelly M. Mahar, Mary Beth Enslin, Angie Gress, Heather Amrine‐Madsen, Melisa Cooper
AbstractOpen‐label single‐ and double‐blind repeat‐dose studies in healthy female volunteers were conducted to investigate the pharmacokinetics (PK) and safety/tolerability of epelsiban total daily doses ranging from 600 to 900 mg. In 1 study (n = 12), epelsiban was dosed at 300 or 450 mg twice daily (every 12 hours) for a single day. In the repeat‐dose double‐blin...... hiện toàn bộ
Base and Covariate Population Pharmacokinetic Analyses of Dupilumab Using Phase 3 Data
Clinical Pharmacology in Drug Development - Tập 9 Số 6 - Trang 756-767 - 2020
Pavel Kovalenko, John D. Davis, Meng Li, Ronda Rippley, Marius Ardeleanu, Brad Shumel, Neil M.H. Graham, Gianluca Pirozzi, Mohamed Kamal, A. Thomas DiCioccio
AbstractPopulation pharmacokinetic base and covariate models were developed to study functional dupilumab for regulatory submissions, using data from healthy volunteers and patients with moderate‐to‐severe atopic dermatitis (AD) receiving intravenous or subcutaneous doses. Sixteen studies were pooled (N = 2115; 202 healthy volunteers, 1913 AD patients). The best mo...... hiện toàn bộ
Pharmacokinetic drug–drug interaction assessment of LCZ696 (an angiotensin receptor neprilysin inhibitor) with omeprazole, metformin or levonorgestrel‐ethinyl estradiol in healthy subjects
Clinical Pharmacology in Drug Development - Tập 5 Số 1 - Trang 27-39 - 2016
Lu Gan, Xiaorui Jiang, Anisha E. Mendonza, Therese Swan, Christine Reynolds, Joanne Nguyen, Parasar Pal, Srikanth Neelakantham, Marion Dahlke, Thomas Langenickel, Iris Rajman, Mizuki Akahori, Wei Zhou, Sam Rebello, Gangadhar Sunkara
AbstractLCZ696 is a novel angiotensin receptor neprilysin inhibitor in development for the treatment of cardiovascular diseases. Here, we assessed the potential for pharmacokinetic drug‐drug interaction of LCZ696 (400 mg, single dose or once daily [q.d.]) when co‐administered with omeprazole 40 mg q.d. (n = 28) or metformin 1000 mg q.d. (n =...... hiện toàn bộ
Population pharmacokinetic and pharmacodynamic analysis of plasma Aβ40 and Aβ42 following single oral doses of the BACE1 inhibitor AZD3839 to healthy volunteers
Clinical Pharmacology in Drug Development - Tập 3 Số 5 - Trang 396-405 - 2014
Angelica Quartino, Gunilla Huledal, Erik Sparve, Maria Lüttgen, Tjerk Bueters, Pär Karlsson, Tina Olsson, Jonathan Paraskos, Justine Maltby, Kristina Claeson‐Bohnstedt, Chi‐Ming Lee, Robert Alexander, Johanna Fälting, Björn Paulsson
AbstractModulating deposition of Aβ‐containing plaques in the brain may be beneficial in treating Alzheimer's disease. β‐site amyloid precursor protein cleaving enzyme 1 (BACE1) inhibitors have been shown to reduce Aβ in plasma and CSF in healthy volunteers. In this study safety, pharmacokinetics and pharmacodynamics that is reduction of the...... hiện toàn bộ
Relative Bioavailability of a Single Dose of Belimumab Administered Subcutaneously by Prefilled Syringe or Autoinjector in Healthy Subjects
Clinical Pharmacology in Drug Development - Tập 5 Số 3 - Trang 208-215 - 2016
Herbert Struemper, Thomas Murtaugh, Jane Gilbert, Matthew E. Barton, Joseph Fire, James Groark, Norma Lynn Fox, David A. Roth, David Gordon
AbstractIntravenous belimumab is approved for the treatment of systemic lupus erythematosus; subcutaneous self‐administration would enable greater patient access. This study assessed relative bioavailability, tolerability, and safety of 1 subcutaneous dose of self‐administered belimumab by healthy subjects using a single‐use autoinjector or prefilled syringe. Subje...... hiện toàn bộ
A Phase 1, Randomized, Placebo‐Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Subcutaneous Tezepelumab in Healthy Japanese Men
Clinical Pharmacology in Drug Development - Tập 9 Số 7 - Trang 833-840 - 2020
Kei Sakamoto, Shunji Matsuki, Shin Irie, Naoki Uchida, Nobuya Hayashi, Masato Horiuchi, Song Ren
AbstractTezepelumab, a human immunoglobulin G2 monoclonal antibody against thymic stromal lymphopoietin, is currently under clinical development for the treatment of severe, uncontrolled asthma. This phase 1, randomized, placebo‐controlled, single‐ascending‐dose study assessed the safety, tolerability, pharmacokinetics, and immunogenicity of subcutaneous tezepeluma...... hiện toàn bộ
Pharmacokinetics and absolute bioavailability of mepolizumab following administration at subcutaneous and intramuscular sites
Clinical Pharmacology in Drug Development - Tập 3 Số 1 - Trang 57-62 - 2014
Héctor Ortega, Steve Yancey, Simon Cozens
AbstractThis study characterized the pharmacokinetics (PK) of mepolizumab, after a single intravenous (IV), subcutaneous (SC), or intramuscular (IM) dose in healthy adults and determined the absolute bioavailability of SC and IM mepolizumab delivered at different anatomical regions. Sixty healthy subjects were randomly assigned to receive a ...... hiện toàn bộ
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