Search Results - "Polepally, Akshanth R."

Drug-drug interaction profile of the all-oral anti-hepatitis C virus regimen of paritaprevir/ritonavir, ombitasvir, and dasabuvir by Menon, Rajeev M, Badri, Prajakta S, Wang, Tianli, Polepally, Akshanth R, Zha, Jiuhong, Khatri, Amit, Wang, Haoyu, Hu, Beibei, Coakley, Eoin P, Podsadecki, Thomas J, Awni, Walid M, Dutta, Sandeep

“…Graphical abstract…”
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Dosing Recommendations for Concomitant Medications During 3D Anti-HCV Therapy by Badri, Prajakta S., King, Jennifer R., Polepally, Akshanth R., McGovern, Barbara H., Dutta, Sandeep, Menon, Rajeev M.

“…The development of direct-acting antiviral (DAA) agents has reinvigorated the treatment of hepatitis C virus infection. The availability of multiple DAA agents…”
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Drug–Drug Interactions Between the Anti-Hepatitis C Virus 3D Regimen of Ombitasvir, Paritaprevir/Ritonavir, and Dasabuvir and Eight Commonly Used Medications in Healthy Volunteers by Polepally, Akshanth R., King, Jennifer R., Ding, Bifeng, Shuster, Diana L., Dumas, Emily O., Khatri, Amit, Chiu, Yi-Lin, Podsadecki, Thomas J., Menon, Rajeev M.

“…Background and Aims The three direct-acting antiviral regimen of ombitasvir/paritaprevir/ritonavir and dasabuvir (3D regimen) is approved for treatment of…”
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Exposure‐Safety Analyses Identify Predictors of Change in Bone Mineral Density and Support Elagolix Labeling for Endometriosis‐Associated Pain by Abbas Suleiman, Ahmed, Nader, Ahmed, Winzenborg, Insa, Beck, Denise, Polepally, Akshanth R., Ng, Juki, Noertersheuser, Peter, Mostafa, Nael M.

“…Elagolix is a novel oral gonadotropin releasing hormone receptor antagonist, that can suppress estradiol in a dose‐dependent manner. It is indicated for…”
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Validation of a quantitative systems pharmacology model of calcium homeostasis using elagolix Phase 3 clinical trial data in women with endometriosis by Stodtmann, Sven, Nader, Ahmed, Polepally, Akshanth R., Suleiman, Ahmed A., Winzenborg, Insa, Noertersheuser, Peter, Ng, Juki, Mostafa, Nael M., Shebley, Mohamad

“…Elagolix is a novel, oral gonadotropin‐releasing hormone receptor antagonist indicated for the management of moderate to severe pain associated with…”
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Effect of Elagolix Exposure on Clinical Efficacy End Points in Phase III Trials in Women With Endometriosis‐Associated Pain: An Application of Markov Model by Winzenborg, Insa, Polepally, Akshanth R., Nader, Ahmed, Mostafa, Nael M., Noertersheuser, Peter, Ng, Juki

“…Elagolix is an oral gonadotropin‐releasing hormone antagonist approved by the US Food and Drug Administration (FDA) for the management of moderate‐to‐severe…”
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A Phase I First-in-Human Study of ABBV-383, a B-Cell Maturation Antigen × CD3 Bispecific T-Cell Redirecting Antibody, in Patients With Relapsed/Refractory Multiple Myeloma by D'Souza, Anita, Shah, Nina, Rodriguez, Cesar, Voorhees, Peter M, Weisel, Katja, Bueno, Orlando F, Pothacamury, Rajvineeth K, Freise, Kevin J, Yue, Susan, Ross, Jeremy A, Polepally, Akshanth R, Talati, Chetasi, Lee, Shane, Jin, Ziyi, Buelow, Ben, Vij, Ravi, Kumar, Shaji

“…ABBV-383, a B-cell maturation antigen × CD3 T-cell engaging bispecific antibody, has demonstrated promising results in an ongoing first-in-human phase I study…”
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Sustained virologic response of 100% in HCV genotype 1b patients with cirrhosis receiving ombitasvir/paritaprevir/r and dasabuvir for 12 weeks by Feld, Jordan J, Moreno, Christophe, Trinh, Roger, Tam, Edward, Bourgeois, Stefan, Horsmans, Yves, Elkhashab, Magdy, Bernstein, David E, Younes, Ziad, Reindollar, Robert W, Larsen, Lois, Fu, Bo, Howieson, Kevin, Polepally, Akshanth R, Pangerl, Andreas, Shulman, Nancy S, Poordad, Fred

“…Graphical abstract…”
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Exposure–Response Relationships for Efficacy and Safety of Risankizumab in Phase II and III Trials in Psoriasis Patients by Khatri, Amit, Suleiman, Ahmed A., Polepally, Akshanth R., Othman, Ahmed A.

“…Risankizumab has demonstrated efficacy in phase III trials in patients with moderate‐to‐severe plaque psoriasis. The exposure–response relationships for…”
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Ombitasvir/paritaprevir/r and dasabuvir plus ribavirin in HCV genotype 1-infected patients on methadone or buprenorphine by Lalezari, Jacob, Sullivan, J. Greg, Varunok, Peter, Galen, Edward, Kowdley, Kris V, Rustgi, Vinod, Aguilar, Humberto, Felizarta, Franco, McGovern, Barbara, King, Martin, Polepally, Akshanth R, Cohen, Daniel E

“…Background & Aims Hepatitis C virus (HCV)-infected patients with a history of injection drug use have low rates of initiation and completion of…”
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Clinical Pharmacology of Elagolix: An Oral Gonadotropin-Releasing Hormone Receptor Antagonist for Endometriosis by Shebley, Mohamad, Polepally, Akshanth R., Nader, Ahmed, Ng, Juki W., Winzenborg, Insa, Klein, Cheri E., Noertersheuser, Peter, Gibbs, Megan A., Mostafa, Nael M.

“…The clinical pharmacology of elagolix was extensively evaluated in clinical studies in healthy subjects and in women with endometriosis. Elagolix…”
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Pharmacokinetics and immunogenicity of eftozanermin alfa in subjects with previously-treated solid tumors or hematologic malignancies: results from a phase 1 first-in-human study by Biesdorf, Carla, Guan, Xiaowen, Siddani, Satya R., Hoffman, David, Boehm, Nils, Medeiros, Bruno C., Doi, Toshihiko, de Jonge, Maja, Rasco, Drew, Menon, Rajeev M., Polepally, Akshanth R.

“…Purpose Eftozanermin alfa is a second-generation tumor necrosis factor-related apoptosis-inducing ligand (TRAIL) receptor agonist that enhances death receptor…”
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First-in-Human Phase I Study of ABBV-085, an Antibody-Drug Conjugate Targeting LRRC15, in Sarcomas and Other Advanced Solid Tumors by Demetri, George D, Luke, Jason J, Hollebecque, Antoine, Powderly, 2nd, John D, Spira, Alexander I, Subbiah, Vivek, Naumovski, Louie, Chen, Chris, Fang, Hua, Lai, Dominic W, Yue, Huibin, Polepally, Akshanth R, Purcell, James W, Robinson, Randy, Sharma, Padmanee, Allison, James P, Tolcher, Anthony, Villalobos, Victor M

“…Leucine-rich repeat containing 15 (LRRC15) is expressed on stromal fibroblasts in the tumor microenvironment of multiple solid tumor types and may represent an…”
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Clinical Pharmacokinetics of Paritaprevir by Menon, Rajeev M., Polepally, Akshanth R., Khatri, Amit, Awni, Walid M., Dutta, Sandeep

“…Paritaprevir is a potent hepatitis C virus (HCV) nonstructural (NS) protein 3/4A protease inhibitor that is used in combination with other direct-acting…”
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Population Pharmacokinetics of Elagolix in Healthy Women and Women with Endometriosis by Winzenborg, Insa, Nader, Ahmed, Polepally, Akshanth R., Liu, Mohan, Degner, Jacob, Klein, Cheri E., Mostafa, Nael M., Noertersheuser, Peter, Ng, Juki

“…Introduction Elagolix is a novel, orally active, non-peptide, competitive gonadotropin-releasing hormone (GnRH) receptor antagonist in development for the…”
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Assessment of Clinical Drug‐Drug Interactions of Elagolix, a Gonadotropin‐Releasing Hormone Receptor Antagonist by Polepally, Akshanth R., Ng, Juki W., Salem, Ahmed Hamed, Dufek, Matthew B., Parikh, Apurvasena, Carter, David C., Kamradt, Kent, Mostafa, Nael M., Shebley, Mohamad

“…Elagolix is an oral gonadotropin‐releasing hormone receptor antagonist indicated for the management of endometriosis‐associated pain and in combination with…”
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Drug Interactions with the Direct-Acting Antiviral Combination of Ombitasvir and Paritaprevir-Ritonavir by Badri, Prajakta S, Dutta, Sandeep, Wang, Haoyu, Podsadecki, Thomas J, Polepally, Akshanth R, Khatri, Amit, Zha, Jiuhong, Chiu, Yi-Lin, Awni, Walid M, Menon, Rajeev M

“…The two direct-acting antiviral (2D) regimen of ombitasvir and paritaprevir (administered with low-dose ritonavir) is being developed for treatment of genotype…”
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Lamotrigine pharmacokinetics following oral and stable‐labeled intravenous administration in young and elderly adult epilepsy patients: Effect of age by Polepally, Akshanth R., Brundage, Richard C., Remmel, Rory P., Leppik, Ilo E., Pennell, Page B., White, James R., Ramsay, R. Eugene, Kistner, Brett M., Birnbaum, Angela K.

“…Summary Objective The objectives of this study were to investigate the effect of age on pharmacokinetic parameters of lamotrigine (LTG) and estimate parameter…”
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Population Pharmacokinetics of Paritaprevir, Ombitasvir, and Ritonavir in Japanese Patients with Hepatitis C Virus Genotype 1b Infection by Gopalakrishnan, Sathej M., Polepally, Akshanth R., Mensing, Sven, Khatri, Amit, Menon, Rajeev M.

“…Background and Objective Hepatitis C virus (HCV) infection is of considerable clinical concern in Japan. We modeled the population pharmacokinetics of an oral…”
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Population pharmacokinetics of paritaprevir, ombitasvir, dasabuvir, ritonavir and ribavirin in hepatitis C virus genotype 1 infection: analysis of six phase III trials by Mensing, Sven, Eckert, Doerthe, Sharma, Shringi, Polepally, Akshanth R., Khatri, Amit, Podsadecki, Thomas J., Awni, Walid M., Menon, Rajeev M., Dutta, Sandeep

“…Aim The aim of the current study was to characterize the population pharmacokinetics of a triple direct‐acting antiviral (DAA) regimen (3D) (ombitasvir,…”
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