Mass Balance, Metabolic Pathways, Absolute Bioavailability, and Pharmacokinetics of Giredestrant in Healthy Subjects

Authors: Kshirsagar, Smita ¹, Chen, Ya-Chi ¹, Yu, Jiajie ¹, Gates, Mary R. ³, Kawakatsu, Sonoko ¹, Khojasteh, S Cyrus ², Ma, Shuguang ², Musib, Luna ¹, Malhi, Vikram ¹, Osaghae, Uyi ⁴, Wang, Jing ², Cho, Sungjoon ², Tang, Yang (Thomas) ², Zhang, Donglu ², Zhao, Weiping ^{2, **}, De Bruyn, Tom ^{2, *}

Source: In Drug Metabolism and Disposition August 2024 52(8):847-857

The Absolute Bioavailability and Absorption, Metabolism, and Excretion of Ipatasertib, a Potent and Highly Selective Protein Kinase B (Akt) Inhibitor

Authors: Takahashi, Ryan H. ^{1, 5}, Malhi, Vikram ^{5, *}, Liederer, Bianca M., Cho, Sungjoon, Deng, Yuzhong, Dean, Brian, Nugteren, James, Yost, Edward, Al-Sayah, Mohammad A. ², Sane, Rucha, Kshirsagar, Smita, Ma, Shuguang ³, Musib, Luna ⁴

Source: In Drug Metabolism and Disposition October 2023 51(10):1332-1341

Pharmacokinetics of Ipatasertib in Subjects With Hepatic Impairment Using 2 Methods of Classification of Hepatic Function

Authors: Sane, Rucha, Malhi, Vikram, Sutaria, Dhruvitkumar S, Cho, Eunpi, Twomey, Patrick, Craggs, Christopher, Wang, Jianshuang, Harris, Adam, Musib, Luna

Source: Journal of clinical pharmacology. 62(2):171-181

Availability: http://explore.bl.uk/primo_library/libweb/action/display.do?tabs=detailsTab&gathStatTab=true&ct=display&fn=search&doc=ETOCvdc_100139249399.0x000001&indx=1&recIds=ETOCvdc_100139249399.0x000001

Time to Rethink the Current Paradigm for Assessing Kidney Function in Drug Development and Beyond

Authors: Sharma, Ashish, Sahasrabudhe, Vaishali, Musib, Luna, Zhang, Steven, Younis, Islam, Kanodia, Jitendra

Source: Clinical pharmacology & therapeutics. 112(5):946-958

Availability: http://explore.bl.uk/primo_library/libweb/action/display.do?tabs=detailsTab&gathStatTab=true&ct=display&fn=search&doc=ETOCvdc_100164329830.0x000001&indx=1&recIds=ETOCvdc_100164329830.0x000001

Evaluation of Ipatasertib Interactions with Itraconazole and Coproporphyrin I and III in a Single Drug Interaction Study in Healthy Subjects

Authors: Sane, Rucha S ^*, Cheung, Kit Wun Kathy, Cho, Eunpi, Liederer, Bianca M, Hanover, Justin, Malhi, Vikram, Plise, Emile, Wong, Susan, Musib, Luna

Source: In The Journal of Pharmacology and Experimental Therapeutics August 2021 378(2):87-95

Effect of Hepatic Impairment on Cobimetinib Pharmacokinetics: The Complex Interplay Between Physiological Changes and Drug Characteristics

Authors: Cheeti, Sravanthi, Deng, Yuzhong, Chang, Ilsung, Georgescu, Isabela, Templeton, Ian, Choong, Nicholas, Cheung, Kit Wun Kathy, Girish, Sandhya, Musib, Luna

Source: Clinical pharmacology in drug development. 10(2):144-152

Availability: http://explore.bl.uk/primo_library/libweb/action/display.do?tabs=detailsTab&gathStatTab=true&ct=display&fn=search&doc=ETOCvdc_100114402870.0x000001&indx=1&recIds=ETOCvdc_100114402870.0x000001

Calibrating the In Vitro–In Vivo Correlation for OATP-Mediated Drug-Drug Interactions with Rosuvastatin Using Static and PBPK Models

Authors: Sane, Rucha ^*, Cheung, Kit Wun Kathy, Kovács, Péter, Farasyn, Taleah ¹, Li, Ruina, Bui, Annamaria, Musib, Luna, Kis, Emese, Plise, Emile, Gáborik, Zsuzsanna ^**

Source: In Drug Metabolism and Disposition December 2020 48(12):1264-1270

Phase Ib study of the MEK inhibitor cobimetinib (GDC-0973) in combination with the PI3K inhibitor pictilisib (GDC-0941) in patients with advanced solid tumors

Authors: Shapiro, Geoffrey I., LoRusso, Patricia, Kwak, Eunice, Pandya, Susan, Rudin, Charles M., Kurkjian, Carla, Cleary, James M., Pilat, Mary Jo, Jones, Suzanne, de Crespigny, Alex, Fredrickson, Jill, Musib, Luna, Yan, Yibing, Wongchenko, Matthew, Hsieh, Hsin-Ju, Gates, Mary R., Chan, Iris T., Bendell, Johanna

Source: Investigational new drugs. 38(2):419-432

Availability: http://explore.bl.uk/primo_library/libweb/action/display.do?tabs=detailsTab&gathStatTab=true&ct=display&fn=search&doc=ETOCvdc_100164277044.0x000001&indx=1&recIds=ETOCvdc_100164277044.0x000001

Association of body-mass index and outcomes in patients with metastatic melanoma treated with targeted therapy, immunotherapy, or chemotherapy: a retrospective, multicohort analysis

Authors: McQuade, Jennifer L ^*, Daniel, Carrie R, Hess, Kenneth R, Mak, Carmen, Wang, Daniel Y, Rai, Rajat R, Park, John J, Haydu, Lauren E, Spencer, Christine, Wongchenko, Matthew, Lane, Stephen, Lee, Dung-Yang, Kaper, Mathilde, McKean, Meredith, Beckermann, Kathryn E, Rubinstein, Samuel M, Rooney, Isabelle, Musib, Luna, Budha, Nageshwar, Hsu, Jessie, Nowicki, Theodore S, Avila, Alexandre, Haas, Tomas, Puligandla, Maneka, Lee, Sandra, Fang, Shenying, Wargo, Jennifer A, Gershenwald, Jeffrey E, Lee, Jeffrey E, Hwu, Patrick, Chapman, Paul B, Sosman, Jeffrey A, Schadendorf, Dirk, Grob, Jean-Jacques, Flaherty, Keith T, Walker, Dana, Yan, Yibing, McKenna, Edward, Legos, Jeffrey J, Carlino, Matteo S, Ribas, Antoni, Kirkwood, John M, Long, Georgina V, Johnson, Douglas B, Menzies, Alexander M, Davies, Michael A

Source: In The Lancet Oncology March 2018 19(3):310-322

Exposure–Response‐Based Product Profile–Driven Clinical Utility Index for Ipatasertib Dose Selection in Prostate Cancer

Authors: Zhu, Rui, Poland, Bill, Wada, Russ, Liu, Qi, Musib, Luna, Maslyar, Daniel, Cho, Eunpi, Yu, Wei, Ma, Han, Jin, Jin Yan, Budha, Nageshwar

Source: CPT: pharmacometrics & systems pharmacology. 8(4):240-248

Availability: http://explore.bl.uk/primo_library/libweb/action/display.do?tabs=detailsTab&gathStatTab=true&ct=display&fn=search&doc=ETOCvdc_100084511703.0x000001&indx=1&recIds=ETOCvdc_100084511703.0x000001

Absorption, Metabolism, Excretion, and the Contribution of Intestinal Metabolism to the Oral Disposition of [14C]Cobimetinib, a MEK Inhibitor, in Humans

Authors: Takahashi, Ryan H ^*, Choo, Edna F, Ma, Shuguang, Wong, Susan, Halladay, Jason ¹, Deng, Yuzhong, Rooney, Isabelle, Gates, Mary, Hop, Cornelis E.C.A, Khojasteh, S. Cyrus, Dresser, Mark J ², Musib, Luna

Source: In Drug Metabolism and Disposition January 2016 44(1):28-39

MEK inhibitors beyond monotherapy: current and future development

Authors: E Templeton, Ian, Musib, Luna

Source: In Current Opinion in Pharmacology August 2015 23:61-67

Determination of cobimetinib in human plasma using protein precipitation extraction and high-performance liquid chromatography coupled to mass spectrometry

Authors: Deng, Yuzhong, Musib, Luna, Choo, Edna, Chapple, Matthew, Burke, Sarah, Johnson, James, Eppler, Steve, Dean, Brian

Source: In Journal of Chromatography B 1 December 2014 972:117-123

Combination of vemurafenib and cobimetinib in patients with advanced BRAFV600-mutated melanoma: a phase 1b study

Authors: Ribas, Antoni, Gonzalez, Rene, Pavlick, Anna, Hamid, Omid, Gajewski, Thomas F, Daud, Adil, Flaherty, Lawrence, Logan, Theodore, Chmielowski, Bartosz, Lewis, Karl, Kee, Damien, Boasberg, Peter, Yin, Ming, Chan, Iris, Musib, Luna, Choong, Nicholas, Puzanov, Igor, McArthur, Grant A

Source: In Lancet Oncology August 2014 15(9):954-965

A Phase II Multicenter Study of Two Different Dosages of Pemetrexed Given in Combination With Cyclophosphamide as First-Line Treatment in Patients With Locally Advanced or Metastatic Breast Cancer

Authors: Dittrich, Christian, Solska, Ewa, Manikhas, Alexey, Eniu, Alexandru, Tjulandin, Sergei, Anghel, Rodica, Musib, Luna, Frimodt-Moller, Bente, Liu, Yushan, Krejcy, Kurt, Láng, István

Source: Cancer investigation. 30(4):309-316

Availability: http://explore.bl.uk/primo_library/libweb/action/display.do?tabs=detailsTab&gathStatTab=true&ct=display&fn=search&doc=ETOCvdc_100103145891.0x000001&indx=1&recIds=ETOCvdc_100103145891.0x000001

Vismodegib Efficacy in Advanced Basal Cell Carcinoma Maintained with 8-Week Dose Interruptions: A Model-Based Evaluation

Authors: Chanu, Pascal, Musib, Luna, Wang, Xin, Cheeti, Sravanthi, Girish, Sandhya, Bruno, Rene, Lu, Tong, Reddy, Josina, Jin, Jin Y., Caro, Ivor

Source: In Journal of Investigative Dermatology April 2021 141(4):930-933

Pediatric Dose Selection and Utility of PBPK in Determining Dose

Authors: Templeton, Ian E., Jones, Nicholas S., Musib, Luna

Source: AAPS journal. 20(2)

Availability: http://explore.bl.uk/primo_library/libweb/action/display.do?tabs=detailsTab&gathStatTab=true&ct=display&fn=search&doc=ETOCvdc_100132848168.0x000001&indx=1&recIds=ETOCvdc_100132848168.0x000001

Application of a Novel 'Make and Test in Parallel' Strategy to Investigate the Effect of Formulation on the Pharmacokinetics of GDC-0810 in Healthy Subjects

Authors: Cheeti, Sravanthi, Hou, Hao Helen, Nelson, Eric, Walker, Helen, Chen, Buyun, Morley, Roland, Gates, Mary, Musib, Luna, Girish, Sandhya, Sahasranaman, Srikumar, Liu, Lichuan

Source: PHARMACEUTICAL RESEARCH. 35(12)

Availability: http://explore.bl.uk/primo_library/libweb/action/display.do?tabs=detailsTab&gathStatTab=true&ct=display&fn=search&doc=ETOCvdc_100127725338.0x000001&indx=1&recIds=ETOCvdc_100127725338.0x000001

Correction to: Application of a Novel 'Make and Test in Parallel' Strategy to Investigate the Effect of Formulation on the Pharmacokinetics of GDC-0810 in Healthy Subjects

Authors: Cheeti, Sravanthi, Hou, Hao Helen, Nelson, Eric, Walker, Helen, Chen, Buyun, Morley, Roland, Gates, Mary, Musib, Luna, Girish, Sandhya, Sahasranaman, Srikumar, Liu, Lichuan

Source: PHARMACEUTICAL RESEARCH. 35(12)

Availability: http://explore.bl.uk/primo_library/libweb/action/display.do?tabs=detailsTab&gathStatTab=true&ct=display&fn=search&doc=ETOCvdc_100127725313.0x000001&indx=1&recIds=ETOCvdc_100127725313.0x000001

Assessment of cytochrome P450 3A4-mediated drug–drug interactions for ipatasertib using a fit-for-purpose physiologically based pharmacokinetic model.

Authors: Jing, Jing, Chen, Yuan, Musib, Luna, Jin, Jin Y., Cheung, Kit Wun Kathy, Yoshida, Kenta, Sane, Rucha

Source: Cancer Chemotherapy & Pharmacology; May2022, Vol. 89 Issue 5, p707-720, 14p