Search Results - "Klamerus, Karen J"

Dose-ranging evaluation of intravitreal siRNA PF-04523655 for diabetic macular edema (the DEGAS study) by Nguyen, Quan Dong, Schachar, Ronald A, Nduaka, Chudy I, Sperling, Marvin, Basile, Anthony S, Klamerus, Karen J, Chi-Burris, Katherine, Yan, Eric, Paggiarino, Dario A, Rosenblatt, Irit, Aitchison, Roger, Erlich, Shai S

“…To evaluate the safety and efficacy of three doses of PF-04523655, a 19-nucleotide methylated double stranded siRNA targeting the RTP801 gene, for the…”
Get full text

Evaluation of the siRNA PF-04523655 versus Ranibizumab for the Treatment of Neovascular Age-related Macular Degeneration (MONET Study) by Nguyen, Quan Dong, MD, MSc, Schachar, Ronald A., MD, PhD, Nduaka, Chudy I., DVM, PhD, Sperling, Marvin, MD, Klamerus, Karen J., PharmD, Chi-Burris, Katherine, MPH, Yan, Eric, PhD, Paggiarino, Dario A., MD, Rosenblatt, Irit, MD, Aitchison, Roger, MS, Erlich, Shai S., PhD

“…Objective To evaluate the efficacy of different dosing paradigms of PF-04523655 (PF) versus ranibizumab (comparator) in subjects with neovascular age-related…”
Get full text

Pharmacokinetics, metabolism, and excretion of [14C]axitinib, a vascular endothelial growth factor receptor tyrosine kinase inhibitor, in humans by Smith, Bill J, Pithavala, Yazdi, Bu, Hai-Zhi, Kang, Ping, Hee, Brian, Deese, Alan J, Pool, William F, Klamerus, Karen J, Wu, Ellen Y, Dalvie, Deepak K

“…The disposition of a single oral dose of 5 mg (100 μCi) of [(14)C]axitinib was investigated in fasted healthy human subjects (N = 8). Axitinib was rapidly…”
Get full text

Effect of food on the pharmacokinetics of sunitinib malate (SU11248), a multi-targeted receptor tyrosine kinase inhibitor: results from a phase I study in healthy subjects by Bello, Carlo L, Sherman, Laurie, Zhou, Jihao, Verkh, Lev, Smeraglia, John, Mount, Janessa, Klamerus, Karen J

“…The effect of food on the oral bioavailability of sunitinib malate (SU11248, an oral, multi-targeted tyrosine kinase inhibitor with anti-angiogenic and…”
Get full text

Pharmacokinetics of Lorlatinib After Single and Multiple Dosing in Patients with Anaplastic Lymphoma Kinase (ALK)-Positive Non-Small Cell Lung Cancer: Results from a Global Phase I/II Study by Chen, Joseph, O’Gorman, Melissa T., James, Lee P., Klamerus, Karen J., Mugundu, Ganesh, Pithavala, Yazdi K.

“…Background Lorlatinib demonstrated efficacy (including intracranial activity) in patients with anaplastic lymphoma kinase ( ALK )-positive non-small cell lung…”
Get full text

Clinical Pharmacology of Axitinib by Chen, Ying, Tortorici, Michael A., Garrett, May, Hee, Brian, Klamerus, Karen J., Pithavala, Yazdi K.

“…Axitinib is a potent and selective second-generation inhibitor of vascular endothelial growth factor receptors 1, 2, and 3 that is approved in the US and…”
Get full text

The effect of tafamidis on the QTc interval in healthy subjects by Klamerus, Karen J., Watsky, Eric, Moller, Robert, Wang, Ronnie, Riley, Steve

“…Aims The transthyretin (TTR) stabilizer, tafamidis, has demonstrated efficacy and safety in the treatment of TTR familial amyloid polyneuropathy (20 mg day−1)…”
Get full text

Impact of Acid‐Reducing Agents on the Pharmacokinetics of Palbociclib, a Weak Base With pH‐Dependent Solubility, With Different Food Intake Conditions by Sun, Wan, Klamerus, Karen J., Yuhas, Lisa M., Pawlak, Sylvester, Plotka, Anna, O'Gorman, Melissa, Kirkovsky, Leonid, Kosa, Maha, Wang, Diane

“…Palbociclib free base capsule is a weak base drug with highly pH‐dependent solubility. In vitro and in vivo studies evaluated the impact of acid‐reducing…”
Get full text

Tofacitinib (CP-690,550), a Janus Kinase Inhibitor for Dry Eye Disease: Results from a Phase 1/2 Trial by SHIAO HUI, NICHOLS, Kelly K, KLAMERUS, Karen J, LI, JimZ, MIN ZHANG, FOULKS, Gary N

“…To evaluate safety and efficacy of topical ophthalmic tofacitinib (CP-690,550), a novel Janus kinase inhibitor, in treating dry eye disease (DED). A phase 1/2…”
Get full text

Tofacitinib (CP-690,550), a Janus Kinase Inhibitor for Dry Eye Disease by Liew, Shiao Hui (Melissa), MBBS, MRCOphth, Nichols, Kelly K., OD, PhD, Klamerus, Karen J., PharmD, Li, Jim Z., PhD, Zhang, Min, MS, Foulks, Gary N., MD, FACS

“…Objective To evaluate safety and efficacy of topical ophthalmic tofacitinib (CP-690,550), a novel Janus kinase inhibitor, in treating dry eye disease (DED)…”
Get full text

Effect of ketoconazole on the pharmacokinetics of axitinib in healthy volunteers by Pithavala, Yazdi K., Tong, Warren, Mount, Janessa, Rahavendran, Sadayappan V., Garrett, May, Hee, Brian, Selaru, Paulina, Sarapa, Nenad, Klamerus, Karen J.

“…Summary Objective Axitinib (AG-013736), an oral, potent, and selective inhibitor of vascular endothelial growth factor receptors 1, 2, and 3, is metabolized…”
Get full text

Evaluation of the effect of food on the pharmacokinetics of axitinib in healthy volunteers by Pithavala, Yazdi K., Chen, Ying, Toh, Melvin, Selaru, Paulina, LaBadie, Robert R., Garrett, May, Hee, Brian, Mount, Janessa, Ni, Grace, Klamerus, Karen J., Tortorici, Michael A.

“…Purpose To evaluate the effect of food on axitinib pharmacokinetics in healthy volunteers with two different crystal polymorphs. Methods Two separate…”
Get full text

Integrating disease progression models, non-clinical pharmacokinetic data and treatment response endpoints to optimize intravitreal dosing regimens by BASILE, Anthony S, JOHNSON, Theodore R, KLAMERUS, Karen J, DUO ZHOU, SULTAN, Marla B, AMANTEA, Mike, NICKENS, Dana J

“…To rapidly identify patients who will ultimately respond to 1 year of therapy, and optimize their inter dose interval. An intravitreal (IVT) ophthalmic dosing…”
Get full text

Evaluation of the potential interaction between tofacitinib and drugs that undergo renal tubular secretion using metformin, an in vivo marker of renal organic cation transporter 2 by Klamerus, Karen J., Alvey, Christine, Li, Lei, Feng, Bo, Wang, Rong, Kaplan, Irina, Shi, Haihong, Dowty, Martin E., Krishnaswami, Sriram

“…Tofacitinib is a novel, oral Janus kinase inhibitor. The potential for drug–drug interactions (DDIs) between tofacitinib and drugs that undergo renal tubular…”
Get full text

Introduction of a composite parameter to the pharmacokinetics of venlafaxine and its active O-desmethyl metabolite by Klamerus, K J, Maloney, K, Rudolph, R L, Sisenwine, S F, Jusko, W J, Chiang, S T

“…Venlafaxine is a structurally novel, nontricyclic compound that is being evaluated for the treatment of various depressive disorders. A randomized three-period…”
Get more information

The effect of tafamidis on the QT c interval in healthy subjects by Klamerus, Karen J., Watsky, Eric, Moller, Robert, Wang, Ronnie, Riley, Steve

“…Aims The transthyretin (TTR) stabilizer, tafamidis, has demonstrated efficacy and safety in the treatment of TTR familial amyloid polyneuropathy (20 mg day −1…”
Get full text

Safety and efficacy of lorlatinib (PF-06463922) from the dose-escalation component of a study in patients with advanced ALK+ or ROS1+ non-small cell lung cancer (NSCLC) by Solomon, Benjamin J., Bauer, Todd Michael, Felip, Enriqueta, Besse, Benjamin, James, Leonard Philip, Clancy, Jill S., Klamerus, Karen J., Martini, Jean-Francois, Abbattista, Antonello, Shaw, Alice Tsang

“…Abstract only…”
Get full text

A Pharmacokinetic and Pharmacodynamic Study of the Potential Drug Interaction between Tasosartan and Atenolol in Patients with Stage 1 and 2 Essential Hypertension by Andrawis, Nabil S., Battle, Michele M., Klamerus, Karen J., Burghart, Peter H., Neefe, Lynne, Weinryb, Ira, Mayer, Philip, Abernethy, Darrell B.

“…The primary objective of this study was to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of tasosartan and atenolol administered alone and…”
Get full text

Effects of age and gender on venlafaxine and O-desmethylvenlafaxine pharmacokinetics by Klamerus, K J, Parker, V D, Rudolph, R L, Derivan, A T, Chiang, S T

“…This single- and multiple-dose, nonrandomized, inpatient study was conducted to determine the effects of age and gender on the pharmacokinetic profiles of the…”
Get more information

Disposition of intravenous amiodarone in subjects with normal and impaired renal function by Ujhelyi, M R, Klamerus, K J, Vadiei, K, O'Rangers, E, Izard, M, Neefe, D L, Zimmerman, J J, Chow, M S

“…In a study designed to determine the influence of renal dysfunction on the disposition of amiodarone and its metabolite, desethylamiodarone (DEA), 30 subjects…”
Get more information