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Odanacatib for the treatment of postmenopausal osteoporosis: results of the LOFT multicentre, randomised, double-blind, placebo-controlled trial and LOFT Extension study.

McClung MR, O'Donoghue ML, Papapoulos SE, Bone H, Langdahl B, Saag KG, Reid IR, Kiel DP, Cavallari I, Bonaca MP, Wiviott SD, de Villiers T, Ling X, Lippuner K, Nakamura T, Reginster JY, Rodriguez-Portales JA, Roux C, Zanchetta J, Zerbini CAF, Park JG, Im K, Cange A, Grip LT, Heyden N, DaSilva C, Cohn D, Massaad R, Scott BB, Verbruggen N, Gurner D, Miller DL, Blair ML, Polis AB, Stoch SA, Santora A, Lombardi A, Leung AT, Kaufman KD, Sabatine MS; LOFT Investigators.

Lancet Diabetes Endocrinol. 2019 Oct 29. pii: S2213-8587(19)30346-8. doi: 10.1016/S2213-8587(19)30346-8. [Epub ahead of print]


Effect of letermovir on levonorgestrel and ethinyl estradiol pharmacokinetics

Adedoyin A, Cho CR, Fox-Bosetti S, Macha S, Zhao T, Liu F, Panebianco D, O'Reilly TE, McCrea J, Stoch SA, Iwamoto M.

Int J Clin Pharmacol Ther. 2019 Sep;57(9):450-457. doi: 10.5414/CP203483.


Thorough QTc Evaluation and the Safety of Supratherapeutic Doses of Odanacatib in Healthy Subjects.

McCrea J, Mostoller K, Mahon C, Liu C, Liu F, Zajic S, Panebianco D, Chakravarthy M, Brandquist C, Gutierrez M, Stoch SA.

Clin Pharmacol Drug Dev. 2019 Oct;8(7):861-870. doi: 10.1002/cpdd.698. Epub 2019 Jun 7.


Midazolam Limited Sampling Strategy With a Population Pharmacokinetic Approach to Simultaneously Estimate Cytochrome P450 (CYP) 3A Constitutive, Inhibition, and Induction/Activation Conditions in Healthy Adults.

Yang J, Nikanjam M, Capparelli EV, Tsunoda SM, Greenberg HE, Penzak SR, Stoch SA, Bertino JS Jr, Nafziger AN, Ma JD.

J Clin Pharmacol. 2019 Nov;59(11):1495-1504. doi: 10.1002/jcph.1440. Epub 2019 May 3.


Pharmacokinetic Drug-Drug Interactions Between Letermovir and the Immunosuppressants Cyclosporine, Tacrolimus, Sirolimus, and Mycophenolate Mofetil.

McCrea JB, Macha S, Adedoyin A, Marshall W, Menzel K, Cho CR, Liu F, Zhao T, Levine V, Kraft WK, Yoon E, Panebianco D, Stoch SA, Iwamoto M.

J Clin Pharmacol. 2019 Oct;59(10):1331-1339. doi: 10.1002/jcph.1423. Epub 2019 Apr 16.


Investigation of Pharmacokinetic Interactions between Doravirine and Elbasvir-Grazoprevir and Ledipasvir-Sofosbuvir.

Ankrom W, Sanchez RI, Yee KL, Fan L, Mitra P, Wolford D, Triantafyllou I, Sterling LM, Stoch SA, Iwamoto M, Khalilieh S.

Antimicrob Agents Chemother. 2019 Apr 25;63(5). pii: e02491-18. doi: 10.1128/AAC.02491-18. Print 2019 May.


Clinical and translational pharmacology of the cathepsin K inhibitor odanacatib studied for osteoporosis.

Stone JA, McCrea JB, Witter R, Zajic S, Stoch SA.

Br J Clin Pharmacol. 2019 Jun;85(6):1072-1083. doi: 10.1111/bcp.13869. Epub 2019 Mar 18. Review.


A randomized clinical trial to evaluate the single-dose pharmacokinetics, pharmacodynamics, and safety of sitagliptin in pediatric patients with type 2 diabetes.

Fraser IP, Neufeld ND, Fox LA, Kipnes MS, Miller TL, Zeitler PS, Rodriguez H, Gilmartin JH, Lee SJ, Patterson JK, Li XS, Maganti L, Luo WL, Tatosian DA, Stoch SA.

Pediatr Diabetes. 2019 Feb;20(1):48-56. doi: 10.1111/pedi.12790. Epub 2018 Nov 13.


Clinical Evaluation of MK-2640: An Insulin Analog With Glucose-Responsive Properties.

Krug AW, Visser SAG, Tsai K, Kandala B, Fancourt C, Thornton B, Morrow L, Kaarsholm NC, Bernstein HS, Stoch SA, Crutchlow M, Kelley DE, Iwamoto M.

Clin Pharmacol Ther. 2019 Feb;105(2):417-425. doi: 10.1002/cpt.1215. Epub 2018 Sep 30.


Native Oxyntomodulin Has Significant Glucoregulatory Effects Independent of Weight Loss in Obese Humans With and Without Type 2 Diabetes.

Shankar SS, Shankar RR, Mixson LA, Miller DL, Pramanik B, O'Dowd AK, Williams DM, Frederick CB, Beals CR, Stoch SA, Steinberg HO, Kelley DE.

Diabetes. 2018 Jun;67(6):1105-1112. doi: 10.2337/db17-1331. Epub 2018 Mar 15.


Odanacatib Pharmacokinetics Comparison Between Chinese and Non-Chinese Postmenopausal Women.

Chen X, Jiang J, Hu P, Zajic S, Liu W, McCrea J, Liu F, Witter R, Mangin E, Stoch SA.

Clin Pharmacol Drug Dev. 2018 Sep;7(7):744-750. doi: 10.1002/cpdd.434. Epub 2018 Feb 14.


An Industry Perspective on the 2017 EMA Guideline on First-in-Human and Early Clinical Trials.

DeGeorge J, Robertson S, Butler L, Derzi M, Stoch SA, Diaz D, Hartke J, Guzzie-Peck P, Mortimer-Cassen E, Bogdanffy M, Will Y, Greene N.

Clin Pharmacol Ther. 2018 Apr;103(4):566-569. doi: 10.1002/cpt.984. Epub 2017 Dec 29.


Evaluation of Therapeutics for Advanced-Stage Heart Failure and Other Severely-Debilitating or Life-Threatening Diseases.

Prescott JS, Andrews PA, Baker RW, Bogdanffy MS, Fields FO, Keller DA, Lapadula DM, Mahoney NM, Paul DE, Platz SJ, Reese DM, Stoch SA, DeGeorge JJ.

Clin Pharmacol Ther. 2017 Aug;102(2):219-227. doi: 10.1002/cpt.730. Epub 2017 Jun 21. Review.


Metabolic improvements following Roux-en-Y surgery assessed by solid meal test in subjects with short duration type 2 diabetes.

Shankar SS, Mixson LA, Chakravarthy M, Chisholm R, Acton AJ, Jones R, Mattar SG, Miller DL, Petry L, Beals CR, Stoch SA, Kelley DE, Considine RV.

BMC Obes. 2017 Mar 1;4:10. doi: 10.1186/s40608-017-0149-1. eCollection 2017.


Validation of a microdose probe drug cocktail for clinical drug interaction assessments for drug transporters and CYP3A.

Prueksaritanont T, Tatosian DA, Chu X, Railkar R, Evers R, Chavez-Eng C, Lutz R, Zeng W, Yabut J, Chan GH, Cai X, Latham AH, Hehman J, Stypinski D, Brejda J, Zhou C, Thornton B, Bateman KP, Fraser I, Stoch SA.

Clin Pharmacol Ther. 2017 Apr;101(4):519-530. doi: 10.1002/cpt.525. Epub 2016 Dec 10.


Effects of Age, Sex, and Obesity on the Single-Dose Pharmacokinetics of Omarigliptin in Healthy Subjects.

Addy C, Tatosian DA, Glasgow XS, Gendrano IN III, Sisk CM, Kauh EA, Stoch SA, Wagner JA.

Clin Pharmacol Drug Dev. 2016 Sep;5(5):374-82. doi: 10.1002/cpdd.255. Epub 2016 Apr 29.


Pharmacodynamic effects of suvorexant and zolpidem on EEG during sleep in healthy subjects.

Struyk A, Gargano C, Drexel M, Stoch SA, Svetnik V, Ma J, Mayleben D.

Eur Neuropsychopharmacol. 2016 Oct;26(10):1649-56. doi: 10.1016/j.euroneuro.2016.07.002. Epub 2016 Aug 20.


The Absolute Bioavailability and Effect of Food on the Pharmacokinetics of Odanacatib: A Stable-Label i.v./Oral Study in Healthy Postmenopausal Women.

Zajic S, Rossenu S, Hreniuk D, Kesisoglou F, McCrea J, Liu F, Sun L, Witter R, Gauthier D, Helmy R, Joss D, Ni T, Stoltz R, Stone J, Stoch SA.

Drug Metab Dispos. 2016 Sep;44(9):1450-8. doi: 10.1124/dmd.116.069906. Epub 2016 Jul 11.


Coadministration of Rifampin Significantly Reduces Odanacatib Concentrations in Healthy Subjects.

Stoch SA, Ballard J, Gibson C, Kesisoglou F, Witter R, Kassahun K, Zajic S, Mehta A, Brandquist C, Dempsey C, Stypinski D, Reitman ML.

J Clin Pharmacol. 2017 Jan;57(1):110-117. doi: 10.1002/jcph.780. Epub 2016 Aug 1.


Pharmacokinetics and Pharmacodynamics of Omarigliptin, a Once-Weekly Dipeptidyl Peptidase-4 (DPP-4) Inhibitor, After Single and Multiple Doses in Healthy Subjects.

Krishna R, Addy C, Tatosian D, Glasgow XS, Gendrano Iii IN, Robberechts M, Haazen W, de Hoon JN, Depré M, Martucci A, Peng JZ, Johnson-Levonas AO, Wagner JA, Stoch SA.

J Clin Pharmacol. 2016 Dec;56(12):1528-1537. doi: 10.1002/jcph.773. Epub 2016 Jun 17.


Linearity of β-cell response across the metabolic spectrum and to pharmacology: insights from a graded glucose infusion-based investigation series.

Shankar SS, Shankar RR, Mixson LA, Miller DL, Chung C, Cilissen C, Beals CR, Stoch SA, Steinberg HO, Kelley DE.

Am J Physiol Endocrinol Metab. 2016 Jun 1;310(11):E865-73. doi: 10.1152/ajpendo.00527.2015. Epub 2016 Apr 12.


Oral follicle-stimulating hormone agonist tested in healthy young women of reproductive age failed to demonstrate effect on follicular development but affected thyroid function.

Gerrits MG, Kramer H, el Galta R, van Beerendonk G, Hanssen R, Abd-Elaziz K, Klipping C, Duijkers I, Stoch SA.

Fertil Steril. 2016 Apr;105(4):1056-1062.e4. doi: 10.1016/j.fertnstert.2015.12.017. Epub 2016 Jan 6.


Best practices for the use of itraconazole as a replacement for ketoconazole in drug-drug interaction studies.

Liu L, Bello A, Dresser MJ, Heald D, Komjathy SF, O'Mara E, Rogge M, Stoch SA, Robertson SM.

J Clin Pharmacol. 2016 Feb;56(2):143-51. doi: 10.1002/jcph.562. Epub 2015 Jul 29. Review.


Clinical pharmacology, creating current and future success in drug development.

Rogge MC, Dresser M, Fossler M, Heald D, Stoch SA, Vanevski KM, Bello A.

J Clin Pharmacol. 2015 Nov;55(11):1193-7. doi: 10.1002/jcph.547. Epub 2015 Jul 14. No abstract available.


Prednisone has no effect on the pharmacokinetics of CYP3A4 metabolized drugs - midazolam and odanacatib.

Marcantonio EE, Ballard J, Gibson CR, Kassahun K, Palamanda J, Tang C, Evers R, Liu C, Zajic S, Mahon C, Mostoller K, Hreniuk D, Mehta A, Morris D, Wagner JA, Stoch SA.

J Clin Pharmacol. 2014 Nov;54(11):1280-9. doi: 10.1002/jcph.338. Epub 2014 Jun 25.


Pitavastatin is a more sensitive and selective organic anion-transporting polypeptide 1B clinical probe than rosuvastatin.

Prueksaritanont T, Chu X, Evers R, Klopfer SO, Caro L, Kothare PA, Dempsey C, Rasmussen S, Houle R, Chan G, Cai X, Valesky R, Fraser IP, Stoch SA.

Br J Clin Pharmacol. 2014 Sep;78(3):587-98. doi: 10.1111/bcp.12377.


Disposition and metabolism of the cathepsin K inhibitor odanacatib in humans.

Kassahun K, McIntosh I, Koeplinger K, Sun L, Talaty JE, Miller DL, Dixon R, Zajic S, Stoch SA.

Drug Metab Dispos. 2014 May;42(5):818-27. doi: 10.1124/dmd.113.056580. Epub 2014 Feb 19.


Odanacatib, a selective cathepsin K inhibitor, demonstrates comparable pharmacodynamics and pharmacokinetics in older men and postmenopausal women.

Anderson MS, Gendrano IN, Liu C, Jeffers S, Mahon C, Mehta A, Mostoller K, Zajic S, Morris D, Lee J, Stoch SA.

J Clin Endocrinol Metab. 2014 Feb;99(2):552-60. doi: 10.1210/jc.2013-1688. Epub 2013 Nov 25.


Odanacatib does not influence the single dose pharmacokinetics and pharmacodynamics of warfarin.

Stoch SA, Witter R, Hrenuik D, Liu C, Zajic S, Mehta A, Chandler P, Morris D, Xue H, Denker A, Wagner JA.

J Popul Ther Clin Pharmacol. 2013;20(3):e312-20. Epub 2013 Oct 2.


Evaluation of partial area under the concentration time curve to estimate midazolam apparent oral clearance for cytochrome P450 3A phenotyping.

Tai W, Gong SL, Tsunoda SM, Greenberg HE, Gorski JC, Penzak SR, Stoch SA, Ma JD.

Drug Metabol Drug Interact. 2013;28(4):217-23. doi: 10.1515/dmdi-2013-0040.


Absence of clinically relevant drug-drug interaction between odanacatib and digoxin after concomitant administration.

Stoch SA, Witter R, Hreniuk D, Liu C, Zajic S, Mehta A, Brandquist C, Dempsey C, Degroot B, Stypinski D, Denker A, Wagner JA.

Int J Clin Pharmacol Ther. 2013 Aug;51(8):688-92. doi: 10.5414/CP201864.


The effects of simvastatin on the pharmacokinectics of sitagliptin.

Cerra M, Luo WL, Li SX, Matthews C, O'Neill EA, Wagner JA, Stoch SA, Anderson MS.

J Popul Ther Clin Pharmacol. 2012;19(3):e356-60. Epub 2012 Oct 11.


Odanacatib, a selective cathepsin K inhibitor to treat osteoporosis: safety, tolerability, pharmacokinetics and pharmacodynamics--results from single oral dose studies in healthy volunteers.

Stoch SA, Zajic S, Stone JA, Miller DL, van Bortel L, Lasseter KC, Pramanik B, Cilissen C, Liu Q, Liu L, Scott BB, Panebianco D, Ding Y, Gottesdiener K, Wagner JA.

Br J Clin Pharmacol. 2013 May;75(5):1240-54. doi: 10.1111/j.1365-2125.2012.04471.x.


Human abuse potential and cognitive effects of taranabant, a cannabinoid 1 receptor inverse agonist: a randomized, double-blind, placebo- and active-controlled, crossover study in recreational polydrug users.

Schoedel KA, Addy C, Chakraborty B, Rosko K, Dunbar S, Maes A, Chen N, Stoch SA, Wagner J, Chodakewitz J, Sellers EM.

J Clin Psychopharmacol. 2012 Aug;32(4):492-502. doi: 10.1097/JCP.0b013e31825d380d.


Pharmacokinetics and tolerability of rizatriptan in pediatric migraineurs in a randomized study.

Fraser IP, Han L, Han TH, Li CC, Hreniuk D, Stoch SA, Wagner JA, Linder S, Winner P.

Headache. 2012 Apr;52(4):625-35. doi: 10.1111/j.1526-4610.2011.02069.x. Epub 2012 Jan 30.


Lack of a meaningful effect of anacetrapib on the pharmacokinetics and pharmacodynamics of warfarin in healthy subjects.

Krishna R, Stypinski D, Ali M, Garg A, Cote J, Maes A, Degroot B, Liu Y, Li S, Connolly SM, Wagner JA, Stoch SA.

Br J Clin Pharmacol. 2012 Jul;74(1):116-24. doi: 10.1111/j.1365-2125.2012.04171.x.


Pharmacokinetics and pharmacodynamics of MK-5046, a bombesin receptor subtype-3 (BRS-3) agonist, in healthy patients.

Reitman ML, Dishy V, Moreau A, Denney WS, Liu C, Kraft WK, Mejia AV, Matson MA, Stoch SA, Wagner JA, Lai E.

J Clin Pharmacol. 2012 Sep;52(9):1306-16. doi: 10.1177/0091270011419854. Epub 2011 Dec 12.


Lack of an effect of anacetrapib on the pharmacokinetics of digoxin in healthy subjects.

Krishna R, Stypinski D, Ali M, Garg A, Gendrano IN 3rd, Maes A, DeGroot B, Liu Y, Li S, Connolly SM, Wagner JA, Stoch SA.

Biopharm Drug Dispos. 2011 Dec;32(9):525-9. doi: 10.1002/bdd.776.


Effect of different durations and formulations of diltiazem on the single-dose pharmacokinetics of midazolam: how long do we go?

Friedman EJ, Fraser IP, Wang YH, Bergman AJ, Li CC, Larson PJ, Chodakewitz J, Wagner JA, Stoch SA.

J Clin Pharmacol. 2011 Nov;51(11):1561-70. doi: 10.1177/0091270010387141. Epub 2011 Jan 5.


Double-blind crossover study to assess potential differences in cytochrome P450 3A4 activity in healthy subjects receiving ondansetron plus dexamethasone, with and without aprepitant.

Stoch SA, Gargano C, Valentine J, Braun MP, Murphy MG, Fedgchin M, Majumdar A, Pequignot E, Gottesdiener KM, Petty KJ, Panebianco D, Dean D, Kraft WK, Greenberg HE.

Cancer Chemother Pharmacol. 2011 Jun;67(6):1313-21. doi: 10.1007/s00280-010-1421-y. Epub 2010 Aug 24.


Pharmacokinetics, safety, and tolerability of phentermine in healthy participants receiving taranabant, a novel cannabinoid-1 receptor (CB1R) inverse agonist.

Addy C, Jumes P, Rosko K, Li S, Li H, Maes A, Johnson-Levonas AO, Chodakewitz J, Stoch SA, Wagner JA.

J Clin Pharmacol. 2009 Oct;49(10):1228-38. doi: 10.1177/0091270009341651.


Single-dose administration of MK-0657, an NR2B-selective NMDA antagonist, does not result in clinically meaningful improvement in motor function in patients with moderate Parkinson's disease.

Addy C, Assaid C, Hreniuk D, Stroh M, Xu Y, Herring WJ, Ellenbogen A, Jinnah HA, Kirby L, Leibowitz MT, Stewart RM, Tarsy D, Tetrud J, Stoch SA, Gottesdiener K, Wagner J.

J Clin Pharmacol. 2009 Jul;49(7):856-64. doi: 10.1177/0091270009336735. Epub 2009 Jun 2.


Once-weekly oral alendronate 70 mg in patients with glucocorticoid-induced bone loss: a 12-month randomized, placebo-controlled clinical trial.

Stoch SA, Saag KG, Greenwald M, Sebba AI, Cohen S, Verbruggen N, Giezek H, West J, Schnitzer TJ.

J Rheumatol. 2009 Aug;36(8):1705-14. doi: 10.3899/jrheum.081207. Epub 2009 Jun 1.


Effect of the cathepsin K inhibitor odanacatib on bone resorption biomarkers in healthy postmenopausal women: two double-blind, randomized, placebo-controlled phase I studies.

Stoch SA, Zajic S, Stone J, Miller DL, Van Dyck K, Gutierrez MJ, De Decker M, Liu L, Liu Q, Scott BB, Panebianco D, Jin B, Duong LT, Gottesdiener K, Wagner JA.

Clin Pharmacol Ther. 2009 Aug;86(2):175-82. doi: 10.1038/clpt.2009.60. Epub 2009 May 6.


Effect of different durations of ketoconazole dosing on the single-dose pharmacokinetics of midazolam: shortening the paradigm.

Stoch SA, Friedman E, Maes A, Yee K, Xu Y, Larson P, Fitzgerald M, Chodakewitz J, Wagner JA.

J Clin Pharmacol. 2009 Apr;49(4):398-406. doi: 10.1177/0091270008331133. Epub 2009 Feb 26.


Model-based decision making in early clinical development: minimizing the impact of a blood pressure adverse event.

Stroh M, Addy C, Wu Y, Stoch SA, Pourkavoos N, Groff M, Xu Y, Wagner J, Gottesdiener K, Shadle C, Wang H, Manser K, Winchell GA, Stone JA.

AAPS J. 2009 Mar;11(1):99-108. doi: 10.1208/s12248-009-9083-6. Epub 2009 Feb 6.


Cathepsin K inhibitors: a novel target for osteoporosis therapy.

Stoch SA, Wagner JA.

Clin Pharmacol Ther. 2008 Jan;83(1):172-6. Epub 2007 Dec 12. Review.


[18F]MK-9470, a positron emission tomography (PET) tracer for in vivo human PET brain imaging of the cannabinoid-1 receptor.

Burns HD, Van Laere K, Sanabria-Bohórquez S, Hamill TG, Bormans G, Eng WS, Gibson R, Ryan C, Connolly B, Patel S, Krause S, Vanko A, Van Hecken A, Dupont P, De Lepeleire I, Rothenberg P, Stoch SA, Cote J, Hagmann WK, Jewell JP, Lin LS, Liu P, Goulet MT, Gottesdiener K, Wagner JA, de Hoon J, Mortelmans L, Fong TM, Hargreaves RJ.

Proc Natl Acad Sci U S A. 2007 Jun 5;104(23):9800-5. Epub 2007 May 29.


Effect of L-000845704, an alphaVbeta3 integrin antagonist, on markers of bone turnover and bone mineral density in postmenopausal osteoporotic women.

Murphy MG, Cerchio K, Stoch SA, Gottesdiener K, Wu M, Recker R; L-000845704 Study Group.

J Clin Endocrinol Metab. 2005 Apr;90(4):2022-8. Epub 2005 Feb 1.


Bone loss in men with prostate cancer treated with gonadotropin-releasing hormone agonists.

Stoch SA, Parker RA, Chen L, Bubley G, Ko YJ, Vincelette A, Greenspan SL.

J Clin Endocrinol Metab. 2001 Jun;86(6):2787-91.


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