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6. Development and Validation of an LC-MS/MS Assay for the Quantitation of MO-OH-Nap Tropolone in Mouse Plasma: Application to In Vitro and In Vivo Pharmacokinetic Studies.

Author

Aldhafiri, Wafaa N., Chhonker, Yashpal S., Ahmed, Nusrat, Singh, Sandeep K., Haney, Staci L., Ford, James B., Holstein, Sarah A., and Murry, Daryl J.

Subjects
LIQUID chromatography-mass spectrometry, BLOOD proteins, TRIFLUOROACETIC acid, TROPOLONE, DAUGHTER ions, PROTEIN binding
Abstract

A rapid, selective, and sensitive liquid chromatography coupled with tandem mass spectrometry (LC-MS/MS) method was developed and validated for the quantitation of MO-OH-Nap tropolone (MO-OH-Nap) in mouse plasma. MO-OH-Nap is an α-substituted tropolone with anti-proliferative properties in various cancer cell lines. Detection and separation of analytes was achieved on an ACE Excel C18 (1.7 µm, 100 × 2.1 mm, MAC-MOD Analytical, Chadds Ford, PA, USA) column with mobile phase consisting of 0.05% trifluoroacetic acid in water (mobile phase A) and 0.05% trifluoroacetic acid in acetonitrile (mobile phase B), with an isocratic elution of 15:85% (A:B) at a total flow rate of 0.25 mL/min. The LC-MS/MS system was operated at unit resolution in multiple reaction monitoring (MRM) mode, using precursor ion > product ion combination of 249.10 > 202.15 m/z for MO-OH-Nap and 305.10 > 215.05 m/z for the internal standard (IS), BA-SM-OM. The MS/MS response was linear over a concentration range of 1 to 500 ng/mL with a correlation coefficient (r2) of ≥0.987. The within- and between-batch precision (%RSD) and accuracy (%Bias) were within acceptable limits. The validated method was successfully applied to determine MO-OH-Nap metabolic stability, plasma protein binding, and bio-distribution studies of MO-OH-Nap in CD-1 mice. [ABSTRACT FROM AUTHOR]

Published
2024
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9. Two distinct amphipathic peptide antibiotics with systemic efficacy

Author

Narayana, Jayaram Lakshmaiah, Mishra, Biswajit, Lushnikova, Tamara, Wu, Qianhui, Chhonker, Yashpal S., Zhang, Yingxia, Zarena, D., Salnikov, Evgeniy S., Dang, Xiangli, Wang, Fangyu, Murphy, Caitlin, Foster, Kirk W., Gorantla, Santhi, Bechinger, Burkhard, Murry, Daryl J., and Wang, Guangshun

Published
2020

12. Simultaneous LC-MS/MS Method for the Quantitation of Probenecid, Albendazole, and Its Metabolites in Human Plasma and Dried Blood Spots.

Author

Rashid, Mamunur, Chhonker, Yashpal S., Singh, Sandeep K., and Murry, Daryl J.

Subjects
MEDICAL personnel, DRUG monitoring, BLOOD plasma, SOLVENT analysis, SOLID phase extraction
Abstract

Highlights: What are the main findings? The validated method was robust, reliable, and sensitive for quantifying ABZ, ABZ-OX, ABZ-ON, and PR simultaneously from the plasma and dried blood spots. The method is well suited for therapeutic drug monitoring due to its high sensitivity, minimal sample volume requirement, and the ability for remote collection. What is the implication of the main finding? Dried blood spot (DBS) analysis represents an alternative sampling technique over conventional blood-sampling methods, particularly for sample collection, enabling a non-clinical setup without requiring special equipment or trained healthcare personnel. Additionally, it minimizes the solvent volume and analysis time and reduces transportation and storage needs. Millions of individuals throughout the world suffer from lymphatic filariasis (LF), which is a morbid disease caused by Wuchereria bancrofti, Brugia malayi, and Brugia timori. These infections belong to tissue-invading nematodes and are one of the major neglected tropical diseases that often result in permanent and enduring disability among individuals in endemic regions. Due to combination therapy, LF eradication has drastically decreased infections globally. The development of blood micro-sampling techniques allowing precise quantitation of drugs in blood would facilitate pharmacokinetic (PK) studies in remote populations. Therefore, an LC-MS/MS bioanalytical method was utilized to analyze albendazole (ABZ), albendazole sulfone (ABZ-ON), albendazole sulfoxide (ABZ-OX), and probenecid (PR) in plasma and dried blood spots. Solid-phase extraction was utilized to extract the analyte from both plasma and blood-spiked DBS. Analytes of interest were eluted with a gradient mobile system using 0.05% formic acid in water (A) and 0.05% formic acid in methanol (B) and separated using a reversed-phase Acquity ®BEH C18 UPLC column (100 × 2.1 mm, 1.7 µm). Precision and accuracy at each QC level were within the acceptable limit, i.e., ±15% for all analytes in both the matrices. Tests for stability under laboratory and storage conditions indicated that no notable changes were observed for plasma and DBS. The LC-MS/MS method demonstrated its capability to consistently identify all target analytes (ABZ, ABZ-ON, ABZ-OX, and PR) at low concentrations, even at the small specimen volumes obtained from DBS cards. This confirms the efficacy and durability of DBS cards as a micro-sampling technique. Moreover, it enhances collection efforts for therapeutic drug monitoring in remote locations for patients infected with lymphatic filariasis. [ABSTRACT FROM AUTHOR]

Published
2024
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13. Pharmacokinetics of Moxidectin combined with Albendazole or Albendazole plus Diethylcarbamazine for Bancroftian Filariasis

Author

Chhonker, Yashpal S., primary, Bjerum, Catherine, additional, Bala, Veenu, additional, Ouattara, Allassane F., additional, Koudou, Benjamin G., additional, Gabo, Toki P., additional, Alshehri, Abdullah, additional, Meïté, Abdoulaye, additional, Fischer, Peter U., additional, Weil, Gary J., additional, King, Christopher L., additional, Budge, Philip J., additional, and Murry, Daryl J., additional

Published
2023
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15. A linked physiologically based pharmacokinetic model for hydroxychloroquine and metabolite desethylhydroxychloroquine in SARS‐CoV‐2(−)/(+) populations

Author

Steinbronn, Claire, primary, Chhonker, Yashpal S., additional, Stewart, Jenell, additional, Leingang, Hannah, additional, Heller, Kate B., additional, Krows, Meighan L., additional, Paasche‐Orlow, Michael, additional, Bershteyn, Anna, additional, Stankiewicz Karita, Helen C., additional, Agrawal, Vaidehi, additional, Laufer, Miriam, additional, Landovitz, Raphael, additional, Wener, Mark, additional, Murry, Daryl J., additional, Johnston, Christine, additional, Barnabas, Ruanne V., additional, and Arnold, Samuel L. M., additional

Published
2023
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16. Biological Evaluation of the Antibacterial Retinoid CD437 in Cutibacterium acnes Infection

Author

Huang, Xiao-wen, primary, Pan, Wen, additional, Zhong, Mei-zhen, additional, Chhonker, Yashpal Singh, additional, Steele, Andrew D., additional, Keohane, Colleen E., additional, Mishra, Biswajit, additional, Felix Raj Lucas, Lewis Oscar, additional, Murry, Daryl J., additional, Ausubel, Frederick M., additional, Wuest, William M., additional, Li, Chang-xing, additional, and Mylonakis, Eleftherios, additional

Published
2023
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21. Piglet cardiopulmonary bypass induces intestinal dysbiosis and barrier dysfunction associated with systemic inflammation

Author

Salomon, Jeffrey D., primary, Qiu, Haowen, additional, Feng, Dan, additional, Owens, Jacob, additional, Khailova, Ludmila, additional, Osorio Lujan, Suzanne, additional, Iguidbashian, John, additional, Chhonker, Yashpal S., additional, Murry, Daryl J., additional, Riethoven, Jean-Jack, additional, Lindsey, Merry L., additional, Singh, Amar B., additional, and Davidson, Jesse A., additional

Published
2023
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25. Population pharmacokinetic model of ivermectin in mass drug administration against lymphatic filariasis.

Author

Alshehri, Abdullah, Chhonker, Yashpal S., Bala, Veenu, Edi, Constant, Bjerum, Catherine M., Koudou, Benjamin G., John, Lucy N., Mitjà, Oriol, Marks, Michael, King, Christopher L., and Murry, Daryl J.

Subjects
FILARIASIS, DRUG administration, PHARMACOKINETICS, IVERMECTIN, POISONS
Abstract

Background: Ivermectin (IVM) is a broad–spectrum anthelmintic drug used to treat diseases caused by filarial worms, such as onchocerciasis and lymphatic filariasis (LF). IVM is part of a triple–drug therapy used by the Mass Drug Administration (MDA) as a preventive strategy to eradicate LF in sub–Saharan Africa. The drug shows high variability in drug exposure in previous pharmacokinetic studies. This study aims to build a population pharmacokinetic (PopPK) model to identify and quantify the possible sources of the variability of IVM exposure after a single–oral dose in LF–infected subjects and healthy individuals. Methodology / Principal findings: In this analysis, 724 samples were collected from treatment–naïve Wuchereria bancrofti–infected (n = 32) and uninfected (n = 24) adults living in Côte d'Ivoire who had received one dose of IVM as a part of triple–drug therapy. PopPK analysis was conducted using Phoenix NLME 8.3 software. The Monte Carlo simulation based on the final model was performed to simulate drug exposure among different dosing groups (200 μg/kg, 18 mg, and 36 mg). A two–compartment model with zero–order dose input into the absorption compartment with a lag time function followed by first–order absorption and linear elimination best described the IVM's pharmacokinetic (PK) parameters. The final model identifies that the PK parameters of IVM are not affected by LF infection. Sex was a significant covariate on the peripheral volume of distribution (Vp/F, 53% lower in men than in women). IVM drug exposure shows linear pharmacokinetic behavior among the simulated dosing groups with similar drug exposure based on sex. Conclusion/Significance: We have developed a PopPk model to describe and identify possible sources of the variability of IVM exposure. To our knowledge, this is the first PopPK study of IVM in patients with LF. Trial registration: NCT02845713; NCT03664063 Author summary: Ivermectin has been shown to be a valuable tool in mass drug administration campaigns against lymphatic filariasis. The drug shows high variability in drug exposure in previous pharmacokinetic studies. Variability in drug exposure can lead to either a higher exposure with the potential for toxic effects or a lower exposure that may result in treatment failure. Identifying and quantifying the source of high variability using non–linear mixed effects modeling is crucial for future dosing recommendations that seek to maximize therapeutic benefit while minimizing toxicity risks. In this study, the variability of IVM exposure after a single oral dose was investigated with a population pharmacokinetic model using data from Lymphatic filariasis infected subjects and healthy individuals. [ABSTRACT FROM AUTHOR]

Published
2023
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26. A simple, high-throughput and validated LC-MS/MS method for the determination of azithromycin in human plasma and its application to a clinical pharmacokinetic study

Author

Zhang, Yuning, Bala, Veenu, Chhonker, Yashpal S, Aldhafiri, Wafaa N, John, Lucy N, Bjerum, Catherine M, King, Christopher L, Mitja, Oriol, Marks, Michael, and Murry, Daryl J

Abstract

A sensitive, specific and rapid liquid chromatographic-tandem mass spectrometric (LC-MS/MS) method was developed and validated to quantify azithromycin concentrations in human plasma. Azithromycin (AZI) is the most common outpatient prescribed antibiotic in the US and clinical studies have demonstrated the efficacy and safety of AZI in many bacterial infections. To support a clinical study, we developed a high-throughput LC-MS/MS method to process up to 250 samples per day to quantify AZI in human plasma. Samples were prepared by solid-phase extraction. Separation was achieved with an ACE C18 column (2.1 × 100 mm, 1.7 μm) equipped with a C18 guard column. The mobile phase consisted of 0.1% formic acid and methanol-acetonitrile (1:1, v/v) at a flow rate of 0.25 ml/min. The ionization was optimized with positive electrospray source using multiple reaction monitoring transition, m/z 749.50 > 591.45 for AZI and m/z 754.50 > 596.45 for AZI-d5. Extraction recoveries were approximately 90% for AZI. The assay was linear from 0.5 to 2,000 ng/ml and required only 100 μl of plasma with a total analysis time of 4.5 min. The method was successfully applied to pharmacokinetic studies of a weight-based dosing protocol for AZI.

Published
2022

33. Pharmacokinetic and safety study of co-administration of albendazole, diethylcarbamazine, Ivermectin and azithromycin for the integrated treatment of Neglected Tropical Diseases

Author

John, Lucy N, Bjerum, Catherine, Martinez, Pere Millat, Likia, Rhoda, Silus, Linda, Wali, Chilaka, Elizah, Arthur, Chhonker, Yashpal S, Bala, Veenu, King, Christopher L, Murry, Daryl J, Mitja, Oriol, and Marks, Michael

Abstract

BACKGROUND: Pharmacokinetic data are a pre-requisite to integrated implementation of large-scale mass drug administration (MDA) for neglected tropical diseases (NTDs). We investigated the safety and drug interactions of a combination of azithromycin (AZI) targeting yaws and trachoma, with the newly approved ivermectin, albendazole, diethylcarbamazine (IDA) regime for Lymphatic Filariasis. METHODOLOGY: An open-label, randomized, 3-arm pharmacokinetic interaction study in adult volunteers was carried out in Lihir Island, Papua New Guinea. Healthy adult participants were recruited and randomized to (I) IDA alone, (II) IDA combined with AZI, (III) AZI alone. The primary outcome was lack of a clinically relevant drug interaction. The secondary outcome was the overall difference in the proportion of AEs between treatment arms. RESULTS: Thirty-seven participants, eighteen men and nineteen women, were randomized and completed the study. There were no significant drug-drug interactions between the study arms. The GMR of Cmax, AUC0-t, and AUC0-∞ for IVM, DEC, ALB-SOX, and AZI were within the range of 80-125% (GMR for AUC0-∞ for IVM, 87.9; DEC, 92.9; ALB-SOX, 100.0; and AZI, 100.1). There was no significant difference in the frequency of AEs across study arms (AZI and IDA alone arms 9/12 (75%), co-administration arm 12/13 (92%); p = 0.44). All AEs were grade 1 and self-limiting. CONCLUSIONS: Co-administration of AZI with IDA did not show evidence of significant drug-interactions. There were no serious AEs in any of the study arms. Our data support further evaluation of the safety of integrated MDA for NTDs.Clinical Trials Registration. NCT03664063.

Published
2020

35. Two distinct amphipathic peptide antibiotics with systemic efficacy

Author

Lakshmaiah Narayana, Jayaram, primary, Mishra, Biswajit, additional, Lushnikova, Tamara, additional, Wu, Qianhui, additional, Chhonker, Yashpal S., additional, Zhang, Yingxia, additional, Zarena, D., additional, Salnikov, Evgeniy S., additional, Dang, Xiangli, additional, Wang, Fangyu, additional, Murphy, Caitlin, additional, Foster, Kirk W., additional, Gorantla, Santhi, additional, Bechinger, Burkhard, additional, Murry, Daryl J., additional, and Wang, Guangshun, additional

Published
2020
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41. Pharmacokinetics, safety, and efficacy of a single co-administered dose of diethylcarbamazine, albendazole and ivermectin in adults with and without Wuchereria bancrofti infection in Côte d’Ivoire

Author

Edi, Constant, primary, Bjerum, Catherine M., additional, Ouattara, Allassane F., additional, Chhonker, Yashpal S., additional, Penali, Louis K., additional, Méité, Aboulaye, additional, Koudou, Benjamin G., additional, Weil, Gary J., additional, King, Christopher L., additional, and Murry, Daryl J., additional

Published
2019
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42. Pharmacokinetics, Safety, and Tolerability of Oxfendazole in Healthy Volunteers: a Randomized, Placebo-Controlled First-in-Human Single-Dose Escalation Study

Author

An, Guohua, primary, Murry, Daryl J., additional, Gajurel, Kiran, additional, Bach, Thanh, additional, Deye, Greg, additional, Stebounova, Larissa V., additional, Codd, Ellen E., additional, Horton, John, additional, Gonzalez, Armando E., additional, Garcia, Hector H., additional, Ince, Dilek, additional, Hodgson-Zingman, Denice, additional, Nomicos, Effie Y. H., additional, Conrad, Thomas, additional, Kennedy, Jessie, additional, Jones, Walt, additional, Gilman, Robert H., additional, and Winokur, Patricia, additional

Published
2019
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43. Pharmacokinetics and efficacy of orally administered polymeric chloroquine as macromolecular drug in the treatment of inflammatory bowel disease

Author

Kanvinde, Shrey, primary, Chhonker, Yashpal Singh, additional, Ahmad, Rizwan, additional, Yu, Fei, additional, Sleightholm, Richard, additional, Tang, Weimin, additional, Jaramillo, Lee, additional, Chen, Yi, additional, Sheinin, Yuri, additional, Li, Jing, additional, Murry, Daryl J., additional, Singh, Amar B., additional, and Oupický, David, additional

Published
2018
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46. Case Report: Ivermectin and Albendazole Plasma Concentrations in a Patient with Disseminated Strongyloidiasis on Extracorporeal Membrane Oxygenation and Continuous Renal Replacement Therapy

Author

Boodman, Carl, primary, Libman, Michael, additional, Charles, Marthe, additional, Chhonker, Yashpal S., additional, Steiner, Theodore, additional, Nishi, Cesilia, additional, Mah, Allison, additional, Murry, Daryl J., additional, and Grant, Jennifer, additional

Published
2018
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48. Abstract A16: The in vitro and in vivo activity of the pyrrolomycin marinopyrrole RL71 alone and combined with temsirolimus (TEM) in MYCN-amplified neuroblastoma (NB)

Author

McGuire, Timothy R., primary, Coulter, Donald W., additional, Liu, Yan, additional, Chhonker, Yashpal S., additional, Murry, Daryl J., additional, Alexander, Gracey R., additional, McIntyre, Erin M., additional, Sughroue, Jason A., additional, Sharp, Graham J., additional, and Li, Rongshi, additional

Published
2018
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