Search results for: C. Kamerling

Items from 1 to 8 out of 8 results

article

Viral clearance, pharmacokinetics and tolerability of ensovibep in patients with mild to moderate COVID‐19: A phase 2a, open‐label, single‐dose escalation study

Manon L. M. Prins, Johan L. Plas, Maurits F. J. M. Vissers, Cécile L. Berends, more

British Journal of Clinical Pharmacology > 89 > 3 > 1105 - 1114

Aim To assess viral clearance, pharmacokinetics, tolerability and symptom evolution following ensovibep administration in symptomatic COVID‐19 outpatients. Methods In this open‐label, first‐in‐patient study a single dose of either 225 mg (n = 6) or 600 mg (n = 6) of ensovibep was administered intravenously in outpatients with mild‐to‐moderate COVID‐19 symptoms. Pharmacokinetic profiles were determined...

article

First‐in‐human trial to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of STR‐324, a dual enkephalinase inhibitor for pain management

Laurence M. Moss, Cecile L. Berends, Emilie M. J. Brummelen, Ingrid M. C. Kamerling, more

British Journal of Clinical Pharmacology > 88 > 1 > 103 - 114

Aim Dual enkephalinase inhibitors (DENKIs) are involved in the regulation of nociception via opioid receptors. The novel compound STR‐324 belongs to the DENKI pharmacological class. This first‐in‐human study evaluated the safety, tolerability, pharmacokinetics and pharmacodynamics of STR‐324 in healthy male participants. Methods This was a randomised, double‐blind, placebo‐controlled ascending...

article

Safety, tolerability and pharmacokinetic characterisation of DACRA KBP‐042 in healthy male subjects

Kim Henriksen, Karen Broekhuizen, Wadim M. I. Boon, Morten A. Karsdal, more

British Journal of Clinical Pharmacology > 87 > 12 > 4786 - 4796

There is a need for antidiabetic agents successfully targeting insulin sensitivity and treating obesity control at the same time. The aim of this first‐in‐human study was (a) to evaluate safety and tolerability, (b) to evaluate pharmacokinetics and (c) to assess indications of receptor engagement of single ascending doses of KBP‐042, a dual amylin and calcitonin receptor agonist (DACRA) that has shown...

article

OC-0380: Moving away from binary definition of PTVs: a novel probabilistic approach to PTV definition

H. Tsang, C. Kamerling, S. Nill, U. Oelfke

Radiotherapy and Oncology > 2016 > 119 > S1 > S178

article

Identifying 24 h variation in the pharmacokinetics of levofloxacin: a population pharmacokinetic approach

Laura Kervezee, Jasper Stevens, Willem Birkhoff, Ingrid M. C. Kamerling, more

British Journal of Clinical Pharmacology > 81 > 2 > 256 - 268

AimThe objective of this study was to investigate whether the pharmacokinetics of orally administered levofloxacin show 24 h variation. Levofloxacin was used as a model compound for solubility and permeability independent absorption and passive renal elimination. MethodsIn this single centre, crossover, open label study, 12 healthy subjects received an oral dose of 1000 mg levofloxacin at six different...

article

A Phase I Dose-Escalation and Bioequivalence Study of a Trastuzumab Biosimilar in Healthy Male Volunteers

Liselijn A. B. Wisman, Eduard P. M. Cock, Joannes A. A. Reijers, Ingrid M. C. Kamerling, more

Clinical Drug Investigation > 2014 > 34 > 12 > 887-894

Background Trastuzumab (Herceptin^®) is a humanized monoclonal antibody targeting the human epidermal growth factor receptor 2 (HER2) and is used in the treatment of HER2-overexpressing breast and gastric cancer. FTMB is being developed as a biosimilar of trastuzumab. Objective In this combined dose-escalation and bioequivalence study of parallel design, the pharmacokinetic profile of FTMB was compared...

article

Efficacy and safety of RPL554, a dual PDE3 and PDE4 inhibitor, in healthy volunteers and in patients with asthma or chronic obstructive pulmonary disease: findings from four clinical trials

Lui G Franciosi, Zuzana Diamant, Katharine H Banner, Rob Zuiker, more

The Lancet Respiratory Medicine > 2013 > 1 > 9 > 714-727

Many patients with asthma or chronic obstructive pulmonary disease (COPD) routinely receive a combination of an inhaled bronchodilator and anti-inflammatory glucocorticosteroid, but those with severe disease often respond poorly to these classes of drug. We assessed the efficacy and safety of a novel inhaled dual phosphodiesterase 3 (PDE3) and PDE4 inhibitor, RPL554 for its ability to act as a bronchodilator...

article

Early stage development of the glycine‐1 re‐uptake inhibitor SCH 900435: central nervous system effects compared with placebo in healthy men

Marieke Liem‐Moolenaar, Pierre Peeters, Ingrid M. C. Kamerling, Chris Hogg, more

British Journal of Clinical Pharmacology > 75 > 6 > 1455 - 1467

AimsTo report the first three studies with SCH 900435, a selective glycine‐1 re‐uptake inhibitor in development for treating schizophrenia, using systematic evaluations of pharmacodynamics to understand the observed effects. MethodsThree double‐blind, placebo‐controlled studies (single, visual effect and multiple dose) were performed. In the single and multiple dose study SCH 900435 (0.5–30 mg) was...

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