References
- International Conference on Harmonisation. ICH harmonised tripartite guideline E14: the clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for nonantiarrhythmic drugs [Internet]. 2005 [cited 2020 Jun 30]. Available from: https://database.ich.org/sites/default/files/E14_Guideline.pdf
- US Food and Drug Administration. E14 clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs — questions and answers (R3). Guidance for industry [Internet]. 2017 [cited 2020 Jun 30]. Available from: https://www.fda.gov/media/71379/download
- International Conference on Harmonisation. E14 Implementation Working Group, ICH E14 guideline: the clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs. Questions & answers (R3) [Internet]. 2015 [cited 2020 Jun 30]. Available from: https://database.ich.org/sites/default/files/E14_Q%26As_R3_Q%26As.pdf,https://database.ich.org/sites/default/files/E14_Q%26As_R3_Concept_Paper.pdf
- Garnett C, Bonate PL, Dang Q, et al. Scientific White Paper on concentration-QTc modeling. J Pharmacokinet Pharmacodyn. 2018;45(3):383–397.
- Tsamandouras N, Duvvuri S, Riley S. Impact of phase 1 study design on estimation of QT interval prolongation risk using exposure-response analysis. J Pharmacokinet Pharmacodyn. 2019;46(6):605–616.
- Pfizer Inc. Daurismo® (glasdegib) prescribing information [Internet]. 2018 [cited 2020 Jun 30]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210656s000lbl.pdf
- Pfizer Inc. Pharmacology/toxicology new drug application review and evaluation [Internet]. 2018 [cited 2020 Jun 30]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210656Orig1s000PharmR.pdf
- Martinelli G, Oehler VG, Papayannidis C, et al. Treatment with PF-04449913, an oral smoothened antagonist, in patients with myeloid malignancies: a phase 1 safety and pharmacokinetics study. Lancet Haematol. 2015;2(8):e339–e46.
- Wagner AJ, Messersmith WA, Shaik MN, et al. A phase I study of PF-04449913, an oral hedgehog inhibitor, in patients with advanced solid tumors. Clin Cancer Res. 2015;21(5):1044–1051.
- Lam JL, Vaz A, Hee B, et al. Metabolism, excretion and pharmacokinetics of [(14)C]glasdegib (PF-04449913) in healthy volunteers following oral administration. Xenobiotica. 2017;47(12):1064–1076.
- Masters JC, LaBadie RR, Salageanu J, et al. Pharmacokinetics and safety of glasdegib in participants with moderate/severe hepatic impairment: a phase I, single-dose, matched case-control study. Clin Pharmacol Drug Dev. 2020. doi:10.1002/cpdd.897
- Shaik N, LaBadie RR, Hee B, et al. Evaluation of the impact of renal impairment on the pharmacokinetics of glasdegib in otherwise healthy volunteers. Cancer Chemother Pharmacol. 2021;87(2):241–250.
- Hnatkova K, Vicente J, Johannesen L, et al. Errors of fixed QT heart rate corrections used in the assessment of drug-induced QTc changes. Front Physiol. 2019;10:635.
- Shaik MN, Hee B, Wei H, et al. Evaluation of the effect of rifampin on the pharmacokinetics of the Smoothened inhibitor glasdegib in healthy volunteers. Br J Clin Pharmacol. 2018;84(6):1346–1353.
- Savona M, Pollyea D, Stock W, et al. Phase Ib study of glasdegib, a Hedgehog pathway inhibitor, in combination with standard chemotherapy in patients with AML or high-risk MDS. Clin Cancer Res. 2018;24(10):2294–2303.
- Shaik MN, LaBadie RR, Rudin D, et al. Evaluation of the effect of food and ketoconazole on the pharmacokinetics of the smoothened inhibitor PF-04449913 in healthy volunteers. Cancer Chemother Pharmacol. 2014;74(2):411–418.
- Sarapa N, Britto MR. Challenges of characterizing proarrhythmic risk due to QTc prolongation induced by nonadjuvant anticancer agents. Expert Opin Drug Saf. 2008;7(3):305–318.
- Masters JC, Shaik N. Population pharmacokinetic/pharmacodynamic evaluation of the effect of glasdegib on QT interval in healthy adult subjects. Poster presented at: the 9th American Conference on Pharmacometrics (ACoP) of the International Society of Pharmacometrics; 2018 Oct 7–10; San Diego, CA.
- Shaik N, Mendes Da Costa L, Hee B, et al. A thorough QT study to evaluate the effect of glasdegib on cardiac repolarization in healthy adult subjects. Poster presented at: the 9th American Conference on Pharmacometrics (ACoP) of the International Society of Pharmacometrics; 2018 Oct 7–10; San Diego, CA.
- Masters JC, Shaik N, Mendes Da Costa L, et al. Clinical and model-based evaluation of the effect of glasdegib on cardiac repolarization from a randomized thorough QT study. Clin Pharmacol Drug Dev. 2021;10(3):272–282.