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Clinical Pharmacology: Advances and Applications

Yan Li, Jamie N Connarn, Jian Chen, Zeen Tong, Maria Palmisano, Simon Zhou
Background: Enasidenib (IDHIFA® , AG-221) is a first-in-class, targeted inhibitor of mutant IDH2 proteins for treatment of relapsed or refractory acute myeloid leukemia. This was a Phase I/II study evaluating safety, efficacy, and pharmacokinetics/pharmacodynamics (PK/PD) of orally administered enasidenib in subjects with advanced hematologic malignancies with an IDH2 mutation. Methods: Blood samples for PK and PD assessment were collected. A semi-mechanistic nonlinear mixed effect PK/PD model was successfully developed to characterize enasidenib plasma PK and to assess enasidenib-induced CYP3A activity...
2019: Clinical Pharmacology: Advances and Applications
Amani H Al-Shaer, Mahmoud S Abu-Samak, Luai Z Hasoun, Beisan A Mohammad, Iman A Basheti
Purpose: Outcomes investigating the effect of vitamin D3 (VD3) and omega-3 fatty acids (Omega-3FA) on serum estradiol (E2) are scarce and conflicting. No previous study has investigated the effect of VD3 combination with Omega-3FA on E2 levels. This study was designed to investigate the effect of VD3, Omega-3FA and VD3 plus Omega-3FA on serum E2 levels in premenopausal females diagnosed with vitamin D deficiency (VDD). Subjects and methods: This randomized, placebo-controlled clinical trial was designed to evaluate the effects of 50,000 IU VD3 taken weekly, 300 mg Omega-3FA taken daily and their combination by the study participants for 8 weeks...
2019: Clinical Pharmacology: Advances and Applications
William G North, Fuli Liu, Konstantin H Dragnev, Eugene Demidenko
Background: Small-cell lung cancer (SCLC) has a poor prognosis since there is currently no effective therapy for commonly recurring disease. In our previous study, both primary and recurrent human tumors have been shown to express functional N -methyl-D-aspartate (NMDA) receptors, and blockade of these receptors with GluN1 and GluN2B antagonists decreased tumor cell viability in vitro, and growth of tumor xenografts in nu/nu mice. Materials and methods: In this study, we examine the influence of the GluN2B antagonist ifenprodil and the channel-blocker antagonist memantine, on cell viability and growth of tumor xenografts of recurrent SCLC (rSCLC) in mice...
2019: Clinical Pharmacology: Advances and Applications
Márcio Cardoso Pinto, Danilo Chorfi Berton, Alexandre Cavenatti de Oliveira, Carolina Martins Lazaro, Silvana Aparecida Calafatti Carandina
Background: Ursodeoxycholic acid (UDCA) and its metabolites tauroursodeoxycholic acid (TUDCA) and glycoursodeoxycholic acid (GUDCA) have been the subject of several pharmacological studies. The objective of this study was to develop an innovative method of quantification by HPL-tandem mass spectrometry (LC-MS/MS), with a lower cost and suitable, for application in bioequivalence studies. Methods: The procedure involved liquid-liquid extraction for quantification of UDCA/GUDCA and precipitation extraction for TUDCA, using deuterated substances as internal standards (ISs) and Phenomenex Luna 250×4...
2019: Clinical Pharmacology: Advances and Applications
Seyyede-Sareh Javadi, Reza Mahjub, Abbas Taher, Younes Mohammadi, Maryam Mehrpooya
Purpose: In critically ill patients, monitoring free phenytoin concentration is a valuable method for phenytoin-dosage adjustment. However, due to technical difficulties and the high cost of these methods, the Sheiner-Tozer equation is routinely used for estimating free phenytoin concentration in clinical practice. There have been conflicting results concerning accuracy and precision of the Sheiner-Tozer equation for prediction of free phenytoin concentration in various patient populations...
2018: Clinical Pharmacology: Advances and Applications
V Mazzarello, M G Donadu, M Ferrari, G Piga, D Usai, S Zanetti, M A Sotgiu
Introduction: Antibiotics that suppress Propionibacterium acnes are the standard treatment for acne but are becoming less effective, due to the appearance of antibiotic-resistant strains. Many plants are known to have innate antimicrobial action and can be used as alternatives to antibiotics; thus, it is necessary to prove their effectiveness in vivo. This study aimed to evaluate the anti-acne efficacy of a new cream based on three natural extracts, comparing it to erythromycin cream and placebo...
2018: Clinical Pharmacology: Advances and Applications
Ying Fei Li, Chengyue Zhang, Simon Zhou, Miao He, Huixia Zhang, Nianhang Chen, Feng Li, Xin Luan, Manjunath Pai, Hebao Yuan, Duxin Sun, Yan Li
Background: Paclitaxel (PTX) products currently approved by the Food and Drug Administration include Kolliphor EL-paclitaxel micelles (KoEL-paclitaxel, Taxol) and nanoparticle albumin-bound paclitaxel ( nab -paclitaxel, Abraxane). Despite containing the same cytotoxic agent, different PTX formulations have distinct pharmacological responses and indications in patients with cancer. Several novel PTX delivery vehicles that have shown superior efficacy to Taxol in animal models failed to demonstrate efficacy in Phase II/III human clinical trials...
2018: Clinical Pharmacology: Advances and Applications
Charles Frost, Andrew Shenker, Stanford Jhee, Zhigang Yu, Jessie Wang, Alexander Bragat, Janice Pursley, Frank LaCreta
Purpose: This double-blind, placebo-controlled, intra-subject, dose-escalation study assessed single-dose safety, pharmacokinetics, and pharmacodynamics of apixaban in healthy Japanese and Caucasian subjects. Subjects and methods: Sixteen healthy male Japanese and sixteen healthy male Caucasian subjects, matched for age, weight, and smoking status were randomized to receive four sequential single oral doses of either apixaban (2.5, 10, 25, and 50 mg) or matched placebo...
2018: Clinical Pharmacology: Advances and Applications
Simone Perna, Manuela Mainardi, Paolo Astrone, Carlotta Gozzer, Anna Biava, Ruben Bacchio, Daniele Spadaccini, Sebastiano Bruno Solerte, Mariangela Rondanelli
Aim: The aim of the present study is to examine the effects on cognitive performance, anthropometric measures, and metabolic markers in 2 different treatments: Incretins vs sodium-glucose co-transporter-2 inhibitors (SGLT2-I). Materials and methods: A randomized controlled clinical trial was carried out on 39 elderly subjects (23 men and 16 women) with type 2 diabetes mellitus, with a mean age of 77.21±8.07 years. Body mass index (BMI) of 29.92±4.31 kg/m2 and a cognitive status measured by a Mini Mental State Examination (scores >27 points)...
2018: Clinical Pharmacology: Advances and Applications
Maha S Al-Keilani, Karem H Alzoubi, Saied A Jaradat
Background: Chemotherapy resistance is the main cause of the marginal clinical benefit of platinum-based chemotherapy and tyrosine kinase inhibitors in advanced non-small-cell lung cancer (NSCLC). Thus, the identification of new therapeutic agents that can enhance the sensitivity of these drugs is of clinical importance. Histone deacetylase inhibitors (HDACIs) are emerging as new promising agents with strong antiproliferative effects against different types of cancers. This study investigates the synergistic potential of sodium phenylbutyrate (NaPB) added on top of standard chemotherapy used against NSCLC...
2018: Clinical Pharmacology: Advances and Applications
Arthur G Roberts, Morgan E Gibbs
As a result of an increasing aging population, the number of individuals taking multiple medications simultaneously has grown considerably. For these individuals, taking multiple medications has increased the risk of undesirable drug-drug interactions (DDIs), which can cause serious and debilitating adverse drug reactions (ADRs). A comprehensive understanding of DDIs is needed to combat these deleterious outcomes. This review provides a synopsis of the pharmacokinetic (PK) and pharmacodynamic (PD) mechanisms that underlie DDIs...
2018: Clinical Pharmacology: Advances and Applications
Felix Oh, Deborah Todhunter, Elizabeth Taras, Daniel A Vallera, Antonella Borgatti
Purpose: Human sarcomas are rare and difficult to treat cancerous tumors typically arising from soft tissue or bone. Conversely, carcinomas are the most common cancer subtype in humans and the primary cause of mortality across all cancer patients. While conventional therapeutic modalities can prolong disease-free intervals and survival in some cases, treatment of refractory or recurrent solid tumors is challenging, and tumor-related mortality remains unacceptably high. The identification of overexpressed cell surface receptors on sarcoma and carcinoma cells has provided a valuable tool to develop targeted toxins as an alternative anticancer strategy...
2018: Clinical Pharmacology: Advances and Applications
Takashi Shigematsu, Ryutaro Shimazaki, Masafumi Fukagawa, Tadao Akizawa
Purpose: Cinacalcet is a positive allosteric modulator of calcium-sensing receptors in the parathyroid gland and an effective treatment for secondary hyperparathyroidism. However, this agent has considerable side effects and dosage limitations, which impair effective treatment. Therefore, we investigated the pharmacokinetics, pharmacodynamics, and safety of the novel calcimimetic, evocalcet. Patients and methods: This was a multicenter, open-label study of single oral doses of 1, 4, and 12 mg evocalcet using an intrapatient dose escalation protocol in 29 Japanese secondary hyperparathyroidism patients receiving hemodialysis...
2018: Clinical Pharmacology: Advances and Applications
Yan Li, Liangang Liu, Lian Huang, Xiaomin Wang, Matthew Hoffmann, Josephine Reyes, Maria Palmisano, Simon Zhou
Objective: The aim of this study was to evaluate the bioavailability of a pomalidomide oral liquid suspension relative to the commercial capsule formulation and to assess the food effect on the pomalidomide oral liquid suspension when administered as a single 4 mg dose. Methods: This was an open-label, randomized, three-period, two-sequence crossover study in healthy subjects consisting of a screening phase, a baseline assessment phase, a treatment phase with three periods, and a follow-up phone call phase...
2018: Clinical Pharmacology: Advances and Applications
Kim Hanna, Maria Cristina Cruz, Elsa Mondou, Edward Corsi, Peter Vandeberg
Background: Rabies immune globulin (RIG) and vaccination series are necessary for postexposure prophylaxis. A new formulation of RIG (human) purified by caprylate/chromatography (RIG-C) was evaluated. Trial registration: identifier: NCT02139657. Materials and methods: This open-label, single-arm study in healthy subjects evaluated neutralizing rabies antibody concentrations produced from a single 20 IU/kg intramuscular (IM) dose of RIG-C as measured by rapid fluorescent focus inhibition test (50% neutralization endpoint) 1-hour postdose and on days 1, 2, 4, 6, 8, 10, 14, 18, and 21...
2018: Clinical Pharmacology: Advances and Applications
Karem H Alzoubi, Zuhair Bani Ismail, Mohamed K Al-Essa, Osama Y Alshogran, Reem F Abutayeh, Nareman Abu-Baker
Introduction: This study explored D-ribose pharmacokinetics after intravenous (IV) and oral administration to healthy rabbits. Materials and methods: D-ribose was administered once as 420 mg/kg (N=4) or 840 mg/kg (N=6) dose intravenously, or as an oral dose of 420 mg/kg (N=3) or 840 mg/kg (N=3). Serum was obtained at various time points, up to 210 minutes after administration. Urine was also collected after IV administration. Pharmacokinetic parameters were determined from drug concentration-time data using Kinetica software...
2018: Clinical Pharmacology: Advances and Applications
(no author information available yet)
[This corrects the article on p. 179 in vol. 6, PMID: 25419161.].
2018: Clinical Pharmacology: Advances and Applications
Linda Tahaineh, Sahar M Edaily, Shadi F Gharaibeh
Objectives: To evaluate the degree of anticoagulation achieved with different enoxaparin dosing regimens used in obese and morbidly obese patients in a hospital setting in Jordan. Methods: All obese adult patients who were prescribed enoxaparin for various indications were invited to participate in the study. The anti-factor Xa (anti-Xa) level was checked once after 4-6 hours of the third or fourth dose of enoxaparin (at steady state). Patients were followed daily to evaluate drug efficacy and safety through their hospital course...
2018: Clinical Pharmacology: Advances and Applications
Yan Li, Xiaomin Wang, Liangang Liu, Josephine Reyes, Maria Palmisano, Simon Zhou
Objective: To assess whether pomalidomide can distribute into human semen and its duration in human semen. Method: A phase 1, randomized, double-blind, placebo-controlled study (CC-4047-CP-006) was conducted to evaluate the safety, tolerability, and pharmacokinetics of pomalidomide (CC-4047) following multiple daily doses in healthy male subjects. Semen samples were collected on Day -1 and 4 hours after dosing on Day 4 to quantify the pomalidomide concentrations in ejaculate after multiple oral doses of pomalidomide...
2018: Clinical Pharmacology: Advances and Applications
Raymond R Tjandrawinata, Arini Setiawati, Dwi Nofiarny, Liana W Susanto, Effi Setiawati
Purpose: The current study aimed to evaluate whether a generic product of etoricoxib 120 mg film-coated tablet (the test drug) was bioequivalent to the reference product (Arcoxia® film-coated tablet 120 mg). Methods: This was a randomized, open-label, two-sequence, crossover study under fasting condition, with a 14-day washout period, involving 26 healthy adult male and female subjects. Blood samples were taken and analyzed for plasma concentrations of etoricoxib (Chemical Abstracts Service [CAS] 202409-33-4) using a high-pressure liquid chromatography-ultraviolet detector (HPLC-UV) system capable of measuring etoricoxib concentrations ranging from 5...
2018: Clinical Pharmacology: Advances and Applications
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