Zhu, Bing Nestorov, Ivan Zhao, Guolin Meka, Venkata Leahy, Mark Kam, Jeanelle Sheikh, Sarah I
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Clinical pharmacology in drug development
Delayed-release dimethyl fumarate (DMF) is an oral therapy for relapsing multiple sclerosis with anti-inflammatory and neuroprotective properties. This 2-period crossover study was conducted to evaluate the potential for drug-drug interaction between DMF (240 mg twice daily) and a combined oral contraceptive (OC; norgestimate 250 μg, ethinyl estrad...
Sellers, Edward M Romach, Myroslava K
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Clinical pharmacology in drug development
All drugs with central nervous system activity must undergo an assessment of their abuse potential, and these data must be included in a New Drug Application. Part of this assessment is an analysis of treatment-emergent adverse events that occur during clinical development. Using an iterative consensus strategy, we evaluated and grouped an availabl...
Xin, Yan Shao, Lixin Maltzman, Julie Stefanidis, Dimitrios Hemenway, Jeffrey Tarnowski, Thomas Deng, Wei Silverman, Jeffrey A
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Clinical pharmacology in drug development
Momelotinib is a potent and selective small-molecule inhibitor of JAK1/2 that is under investigation for the treatment of myeloproliferative neoplasms. In a phase 1/2 study in myelofibrosis patients, once-daily dosing of a 300-mg momelotinib capsule was selected for further development based on a favorable benefit:risk profile. A tablet formulation...
White, William B Hewitt, L Arthur Mehdirad, Ali A
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Clinical pharmacology in drug development
A double-blind, 4-period crossover study (NCT01327066) was conducted to assess the effect of the novel norepinephrine prodrug droxidopa on the QT interval in in healthy subjects. Subjects were randomized to receive a single dose of droxidopa 600 mg (maximal dose) and 2000 mg (supratherapeutic dose) compared with the positive control, moxifloxacin 4...
Kropeit, Dirk von Richter, Oliver Stobernack, Hans-Peter Rübsamen-Schaeff, Helga Zimmermann, Holger
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Clinical pharmacology in drug development
Letermovir is being developed for human cytomegalovirus infection treatment and prophylaxis. In patients receiving transplants, antivirals are coadministered with cyclosporine A (CsA) or tacrolimus (TAC) immunosuppressants. Therefore, we investigated the potential for letermovir-immunosuppressant interactions. In 2 phase 1 clinical trials either Cs...
Samukawa, Yoshishige Sata, Michio Furihata, Kenichi Ito, Toshifumi Ueda, Naohiko Ochiai, Hidekazu Sakai, Soichi Kumagai, Yuji
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Clinical pharmacology in drug development
This open-label, parallel-group study evaluated the effect of mild and moderate hepatic impairment on the pharmacokinetics of a single dose of luseogliflozin in Japanese subjects. Thirteen subjects with hepatic impairment (mild, n = 8; moderate, n = 5) and 6 healthy subjects received a single 5-mg dose of luseogliflozin. Serial blood sampling over ...
Sallee, Floyd R Palumbo, Donna R Abbas, Richat Berry, Sally A Puthli, Shivanand P Kathala, Kalyan K
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Clinical pharmacology in drug development
We conducted an open-label, single-dose, randomized, crossover study in healthy adults to assess the impact of food on the bioavailability of 60 mg methylphenidate extended-release oral suspension (MEROS; Quillivant XR™)-a long-acting stimulant for the treatment of attention deficit hyperactivity disorder-by comparing the pharmacokinetic parameters...
Tran, Jonathan Q Hartung, Jeffrey P Olson, Allan D Mendzelevski, Boaz Timony, Gregg A Boehm, Marcus F Peach, Robert J Gujrathi, Sheila Frohna, Paul A
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Clinical pharmacology in drug development
Ozanimod is a novel, selective, oral sphingosine-1-phosphate (1 and 5) receptor modulator in development for multiple sclerosis and inflammatory bowel disease. This randomized, double-blind, placebo-controlled, positive-controlled, parallel-group thorough QT study characterized the effects of ozanimod on cardiac repolarization in healthy subjects. ...
Townsend, Robert Kato, Kota Hale, Christine Kowalski, Donna Lademacher, Christopher Yamazaki, Takao Akhtar, Shahzad Desai, Amit
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Clinical pharmacology in drug development
Isavuconazonium sulfate is the water-soluble prodrug of the active triazole isavuconazole. Two phase 1 studies were conducted to identify the metabolic profile and mass balance of isavuconazole and BAL8728 (inactive cleavage product). Seven subjects in study 1 (isavuconazole mass balance) received a single oral dose of [cyano-14 C]isavuconazonium s...
Noda, Yoshinori Nilsson, Catarina Shimada, Hitoshi Kim, Hyosung Lundström, Torbjörn Yajima, Toshitaka
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Clinical pharmacology in drug development
OM3-CA (omega-3-carboxylic acids) is a complex mixture of omega-3 carboxylic acids, particularly eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), which is approved in the United States for the treatment of hypertriglyceridemia. As part of its clinical development in Japan, we performed a phase 1 study to investigate the safety, tolerabil...
