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Article ; Online: A Phase 1 Clinical Study Evaluating the Effects of Cenobamate on the QT Interval.

Darpo, Borje / Sager, Philip T / Xue, Hongqi / Kamin, Marc

Clinical pharmacology in drug development

2022 Volume 11, Issue 4, Page(s) 523–534

Abstract: Cenobamate is an antiseizure medication for uncontrolled focal seizures. This thorough QT study assessed the effects of therapeutic and supratherapeutic cenobamate doses (maximum recommended dose, 400 mg/day) on correct QT interval (QTc) in healthy ... ...

Abstract	Cenobamate is an antiseizure medication for uncontrolled focal seizures. This thorough QT study assessed the effects of therapeutic and supratherapeutic cenobamate doses (maximum recommended dose, 400 mg/day) on correct QT interval (QTc) in healthy adults (N = 108) randomly assigned to 1 of 3 treatments: (A) cenobamate (days 1-63) up-titrated by 50-mg increments weekly to a 200 mg/day therapeutic dose (day 35) and then by 100 mg weekly to a 500 mg/day supratherapeutic dose (day 63), with placebo-moxifloxacin (days -1 and 64); (B) moxifloxacin 400 mg (day -1; positive control), placebo-cenobamate (days 1-63), and placebo-moxifloxacin (day 64); and (C) placebo-moxifloxacin (day -1), placebo-cenobamate (days 1-64), and moxifloxacin 400 mg (day 64). The primary end point was baseline-adjusted, placebo-corrected QTc (ΔΔQTcF; corrected for heart rate [HR] by Fridericia's method) with cenobamate 200 and 500 mg/day. Baseline electrocardiographic parameters were balanced across groups. Mean ΔΔQTcF was negative throughout for cenobamate doses (largest: day 35, -10.8 milliseconds; day 63, -18.4 milliseconds). Based on concentration-QTc analysis, ∆∆QTcF effect was predicted as -9.85 and -17.14 milliseconds at mean peak plasma levels of therapeutic (200 mg/day; 23.06 μg/mL) and supratherapeutic (500 mg/day; 63.96 μg/mL) doses. Cenobamate had no clinically relevant prolonging effect on electrocardiographic parameters (eg, PR, QRS); HR effects were similar to placebo. Cenobamate showed slight dose-related shortening of QTc, but to a degree not known to be clinically relevant (no reductions ≤340 milliseconds). Cenobamate had no clinically relevant effects on HR or electrocardiographic parameters and no QTc-prolonging effect at therapeutic/supratherapeutic doses. Cenobamate is contraindicated in patients with short-QT syndrome and caution should be used when coadministering with drugs that shorten QT interval.
MeSH term(s)	Adult ; Carbamates/adverse effects ; Chlorophenols ; Double-Blind Method ; Humans ; Long QT Syndrome/chemically induced ; Tetrazoles
Chemical Substances	Carbamates ; Chlorophenols ; Tetrazoles ; Cenobamate (P85X70RZWS)
Language	English
Publishing date	2022-02-19
Publishing country	United States
Document type	Clinical Trial, Phase I ; Journal Article ; Randomized Controlled Trial
ZDB-ID	2649010-9
ISSN	2160-7648 ; 2160-763X
ISSN (online)	2160-7648
ISSN	2160-763X
DOI	10.1002/cpdd.1077
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Article ; Online: SGK1 inhibition attenuated the action potential duration in patient- and genotype-specific re-engineered heart cells with congenital long QT syndrome.

Kim, Maengjo / Das, Saumya / Tester, David J / Pradhananga, Sabindra / Hamrick, Samantha K / Gao, Xiaozhi / Srinivasan, Dinesh / Sager, Philip T / Ackerman, Michael J

Heart rhythm O2

2023 Volume 4, Issue 4, Page(s) 268–274

Abstract: Background: Long QT syndrome (LQTS) stems from pathogenic variants in : Objective: The study sought to test the efficacy of novel, selective SGK1 inhibitors in induced pluripotent stem cell-derived cardiomyocyte (iPSC-CM) models of LQTS.: Methods: ...

Abstract	Background: Long QT syndrome (LQTS) stems from pathogenic variants in Objective: The study sought to test the efficacy of novel, selective SGK1 inhibitors in induced pluripotent stem cell-derived cardiomyocyte (iPSC-CM) models of LQTS. Methods: The mexiletine (MEX)-sensitive SCN5A-P1332L iPSC-CMs were tested initially compared with a CRISPR (clustered regularly interspaced short palindromic repeats)/Cas9 SCN5A-P1332L variant-corrected isogenic control (IC). The SGK1-I1 therapeutic efficacy, compared with MEX, was tested for APD at 90% repolarization (APD90) shortening in SCN5A-P1332L, SCN5A-R1623Q, KCNH2-G604S, and KCNQ1-V254M iPSC-CMs using FluoVolt. Results: The APD90 was prolonged in SCN5A-P1332L iPSC-CMs compared with its IC (646 ± 7 ms vs 482 ± 23 ms; Conclusions: Therapeutically inhibiting SGK1 effectively shortens the APD in human iPSC-CM models of the 3 major LQTS genotypes. These preclinical data support development of SGK1 inhibitors as novel, first-in-class therapy for patients with congenital LQTS.
Language	English
Publishing date	2023-02-16
Publishing country	United States
Document type	Journal Article
ISSN	2666-5018
ISSN (online)	2666-5018
DOI	10.1016/j.hroo.2023.02.003
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Article ; Online: SGK1 inhibition attenuates the action potential duration in reengineered heart cell models of drug-induced QT prolongation.

Kim, Maengjo / Sager, Philip T / Tester, David J / Pradhananga, Sabindra / Hamrick, Samantha K / Srinivasan, Dinesh / Das, Saumya / Ackerman, Michael J

Heart rhythm

2023 Volume 20, Issue 4, Page(s) 589–595

Abstract: Background: Drug-induced QT prolongation (DI-QTP) is a clinical entity in which administration of a human ether-à-go-go-related gene/rapid delayed rectifier potassium current blocker such as dofetilide prolongs the cardiac action potential duration (APD) ...

Abstract	Background: Drug-induced QT prolongation (DI-QTP) is a clinical entity in which administration of a human ether-à-go-go-related gene/rapid delayed rectifier potassium current blocker such as dofetilide prolongs the cardiac action potential duration (APD) and the QT interval on the electrocardiogram. Inhibition of serum and glucocorticoid regulated kinase-1 (SGK1) reduces the APD at 90% repolarization (APD90) in induced pluripotent stem cell-derived cardiomyocytes (iPSC-CMs) derived from patients with congenital long QT syndrome. Objective: Here, we test the efficacy of 2 novel SGK1 inhibitors-SGK1-I1 and SGK1-I2-in iPSC-CM models of dofetilide-induced APD prolongation. Methods: Normal iPSC-CMs were treated with dofetilide to produce a DI-QTP iPSC-CM model. SGK1-I1's and SGK1-I2's therapeutic efficacy for shortening the dofetilide-induced APD90 prolongation was compared to mexiletine. The APD90 values were recorded 4 hours after treatment using a voltage-sensing dye. Results: The APD90 was prolonged in normal iPSC-CMs treated with dofetilide (673 ± 8 ms vs 436 ± 4 ms; P < .0001). While 10 mM mexiletine shortened the APD90 of dofetilide-treated iPSC-CMs from 673 ± 4 to 563 ± 8 ms (46% attenuation; P < .0001), 30 nM of SGK1-I1 shortened the APD90 from 673 ± 8 to 502 ± 7 ms (72% attenuation; P < .0001). Additionally, 300 nM SGK1-I2 shortened the APD90 of dofetilide-treated iPSC-CMs from 673 ± 8 to 460 ± 7 ms (90% attenuation; P < .0001). Conclusion: These novel SGK1-Is substantially attenuated the pathological APD prolongation in a human heart cell model of DI-QTP. These preclinical data support the development of this therapeutic strategy to counter and neutralize DI-QTP, thereby increasing the safety profile for patients receiving drugs with torsadogenic potential.
MeSH term(s)	Humans ; Mexiletine/pharmacology ; Action Potentials ; Long QT Syndrome/chemically induced ; Long QT Syndrome/drug therapy ; Long QT Syndrome/pathology ; Sulfonamides/adverse effects ; Myocytes, Cardiac/pathology
Chemical Substances	Mexiletine (1U511HHV4Z) ; dofetilide (R4Z9X1N2ND) ; Sulfonamides
Language	English
Publishing date	2023-01-05
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2229357-7
ISSN	1556-3871 ; 1547-5271
ISSN (online)	1556-3871
ISSN	1547-5271
DOI	10.1016/j.hrthm.2022.12.036
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Article ; Online: Why translation from basic discoveries to clinical applications is so difficult for atrial fibrillation and possible approaches to improving it.

Nattel, Stanley / Sager, Philip T / Hüser, Jörg / Heijman, Jordi / Dobrev, Dobromir

Cardiovascular research

2021 Volume 117, Issue 7, Page(s) 1616–1631

Abstract: Atrial fibrillation (AF) is the most common sustained clinical arrhythmia, with a lifetime incidence of up to 37%, and is a major contributor to population morbidity and mortality. Important components of AF management include control of cardiac rhythm, ... ...

Abstract	Atrial fibrillation (AF) is the most common sustained clinical arrhythmia, with a lifetime incidence of up to 37%, and is a major contributor to population morbidity and mortality. Important components of AF management include control of cardiac rhythm, rate, and thromboembolic risk. In this narrative review article, we focus on rhythm-control therapy. The available therapies for cardiac rhythm control include antiarrhythmic drugs and catheter-based ablation procedures; both of these are presently neither optimally effective nor safe. In order to develop improved treatment options, it is necessary to use preclinical models, both to identify novel mechanism-based therapeutic targets and to test the effects of putative therapies before initiating clinical trials. Extensive research over the past 30 years has provided many insights into AF mechanisms that can be used to design new rhythm-maintenance approaches. However, it has proven very difficult to translate these mechanistic discoveries into clinically applicable safe and effective new therapies. The aim of this article is to explore the challenges that underlie this phenomenon. We begin by considering the basic problem of AF, including its clinical importance, the current therapeutic landscape, the drug development pipeline, and the notion of upstream therapy. We then discuss the currently available preclinical models of AF and their limitations, and move on to regulatory hurdles and considerations and then review industry concerns and strategies. Finally, we evaluate potential paths forward, attempting to derive insights from the developmental history of currently used approaches and suggesting possible paths for the future. While the introduction of successful conceptually innovative new treatments for AF control is proving extremely difficult, one significant breakthrough is likely to revolutionize both AF management and the therapeutic development landscape.
MeSH term(s)	Action Potentials/drug effects ; Animals ; Anti-Arrhythmia Agents/adverse effects ; Anti-Arrhythmia Agents/therapeutic use ; Atrial Fibrillation/diagnosis ; Atrial Fibrillation/drug therapy ; Atrial Fibrillation/physiopathology ; Diffusion of Innovation ; Disease Models, Animal ; Drug Approval ; Drug Development/trends ; Drug Discovery/trends ; Forecasting ; Heart Conduction System/drug effects ; Heart Conduction System/physiopathology ; Heart Rate/drug effects ; Humans ; Translational Research, Biomedical
Chemical Substances	Anti-Arrhythmia Agents
Language	English
Publishing date	2021-03-22
Publishing country	England
Document type	Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't ; Review
ZDB-ID	80340-6
ISSN	1755-3245 ; 0008-6363
ISSN (online)	1755-3245
ISSN	0008-6363
DOI	10.1093/cvr/cvab093
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Zs.A 565: Show issues

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Article ; Online: Rationale for and design of a multicenter, placebo-controlled, phase 3 study to assess efficacy and safety of intranasal etripamil for the conversion of paroxysmal supraventricular tachycardia.

Stambler, Bruce S / Plat, Francis / Sager, Philip T / Lubkov, Veronica / Shardonofsky, Silvia / Wight, Douglas / Chen, Michael / Camm, A John

American heart journal

2022 Volume 253, Page(s) 20–29

Abstract: Presently, acute pharmacological termination of paroxysmal supraventricular tachycardia (PSVT) unresponsive to patient-initiated vagal maneuvers requires in-hospital intervention. Etripamil, a fast-acting, nondihydropyridine, L-type calcium channel ... ...

Abstract	Presently, acute pharmacological termination of paroxysmal supraventricular tachycardia (PSVT) unresponsive to patient-initiated vagal maneuvers requires in-hospital intervention. Etripamil, a fast-acting, nondihydropyridine, L-type calcium channel blocker, is formulated as an intranasal spray to rapidly terminate atrioventricular (AV) nodal-dependent PSVT in a medically unsupervised setting. The NODE-301 study did not meet its prespecified primary end point of PSVT conversion over 5 hours following a single dose of etripamil 70 mg. However, analysis at earlier time points demonstrated etripamil treatment effect during the first 30 minutes, consistent with its expected rapid onset and short duration of action. This led to the design of the RAPID study, which includes a new dosing regimen (up to 2 etripamil 70 mg doses separated by 10 minutes) to increase the exposure and pharmacodynamic effect of etripamil. The primary objective of RAPID (NCT03464019) is to determine if etripamil self-administered by patients is superior to placebo in terminating PSVT in an at-home setting. The secondary objective is to evaluate the safety of etripamil when self-administered by patients without medical supervision. Additional efficacy end points include the proportion of patients requiring additional medical intervention in an emergency department to terminate PSVT and patient-reported outcomes. After successfully completing a test dose to assess the safety of 2 70 mg doses of etripamil during sinus rhythm, approximately 500 patients will be randomized 1:1 to etripamil or placebo to accrue 180 positively adjudicated AV nodal-dependent PSVT events for treatment with the study drug. Etripamil may offer a new alternative to the current in-hospital treatment modality, providing for safe and effective at-home termination of PSVT.
MeSH term(s)	Benzoates/therapeutic use ; Humans ; Tachycardia, Paroxysmal/drug therapy ; Tachycardia, Supraventricular ; Tachycardia, Ventricular
Chemical Substances	Benzoates ; etripamil (S82A18Y42P)
Language	English
Publishing date	2022-06-18
Publishing country	United States
Document type	Clinical Trial, Phase III ; Journal Article ; Multicenter Study ; Randomized Controlled Trial
ZDB-ID	80026-0
ISSN	1097-6744 ; 0002-8703
ISSN (online)	1097-6744
ISSN	0002-8703
DOI	10.1016/j.ahj.2022.06.005
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Article ; Online: Methodological and Regulatory Considerations for Updated Guidance on the Pressor Effects of Drugs.

Harrison, Nicholas R / Sager, Philip T / Krucoff, Mitchell W / Weber, Michael A / White, William B

Therapeutic innovation & regulatory science

2020 Volume 54, Issue 6, Page(s) 1473–1476

Abstract: Elevated blood pressure increases the risk of adverse cardiovascular events and death. Accordingly, characterizing the off-target blood pressure effects of drugs is an important component of regulatory benefit-risk assessment and post-marketing clinical ... ...

Abstract	Elevated blood pressure increases the risk of adverse cardiovascular events and death. Accordingly, characterizing the off-target blood pressure effects of drugs is an important component of regulatory benefit-risk assessment and post-marketing clinical decision-making. The U.S. Food and Drug Administration (FDA) released draft guidance in May 2018 outlining these considerations and seeking discussion regarding opportunities to improve or reassess methods and analytical techniques to measure and interpret the pressor effects of drugs. Toward this effort, the Duke-Margolis Center for Health Policy-under a cooperative agreement with the FDA-convened a public workshop to bring the stakeholder community together to discuss these opportunities. The following are summary statements and recommendations discussed at the workshop to improve blood pressure assessment throughout the product lifecycle, from development and regulatory review to clinical care.
MeSH term(s)	Blood Pressure ; Pharmaceutical Preparations ; Risk Assessment ; United States ; United States Food and Drug Administration
Chemical Substances	Pharmaceutical Preparations
Language	English
Publishing date	2020-06-04
Publishing country	Switzerland
Document type	Journal Article ; Research Support, U.S. Gov't, Non-P.H.S.
ZDB-ID	2708397-4
ISSN	2168-4804 ; 2168-4790
ISSN (online)	2168-4804
ISSN	2168-4790
DOI	10.1007/s43441-020-00174-8
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Article ; Online: The thorough QT study: Is its demise on the horizon?

Sager, Philip T / Kowey, Peter

Annals of noninvasive electrocardiology : the official journal of the International Society for Holter and Noninvasive Electrocardiology, Inc

2014 Volume 19, Issue 1, Page(s) 1–3

MeSH term(s)	Clinical Trials, Phase I as Topic/methods ; Drug Evaluation, Preclinical/methods ; Electrocardiography/drug effects ; Electrocardiography/methods ; Humans ; Prospective Studies ; Research Design/statistics & numerical data
Language	English
Publishing date	2014-01-08
Publishing country	United States
Document type	Editorial ; Comment
ZDB-ID	1325530-7
ISSN	1542-474X ; 1082-720X
ISSN (online)	1542-474X
ISSN	1082-720X
DOI	10.1111/anec.12127
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Article ; Online: Influence of Meals and Glycemic Changes on QT Interval Dynamics.

Cirincione, Brenda / Sager, Philip T / Mager, Donald E

Journal of clinical pharmacology

2017 Volume 57, Issue 8, Page(s) 966–976

Abstract: Thorough QT/QTc studies have become an integral part of early drug development programs, with major clinical and regulatory implications. This analysis expands on existing pharmacodynamic models of QT interval analysis by incorporating the influence of ... ...

Abstract	Thorough QT/QTc studies have become an integral part of early drug development programs, with major clinical and regulatory implications. This analysis expands on existing pharmacodynamic models of QT interval analysis by incorporating the influence of glycemic changes on the QT interval in a semimechanistic manner. A total of 21 healthy subjects enrolled in an open-label phase 1 pilot study and provided continuous electrocardiogram monitoring and plasma glucose and insulin concentrations associated with a 24-hour baseline assessment. The data revealed a transient decrease in QTc, with peak suppression occurring approximately 3 hours after the meal. A semimechanistic modeling approach was applied to evaluate temporal delays between meals and subsequent changes that might influence QT measurements. The food effect was incorporated into a model of heart rate dynamics, and additional delayed effects of the meal on QT were incorporated using a glucose-dependent hypothetical transit compartment. The final model helps to provide a foundation for the future design and analysis of QT studies that may be confounded by meals. This study has significant implications for QT study assessment following a meal or when a cohort is receiving a medication that influences postprandial glucose concentrations.
Language	English
Publishing date	2017-08
Publishing country	England
Document type	Journal Article
ZDB-ID	188980-1
ISSN	1552-4604 ; 0091-2700 ; 0021-9754
ISSN (online)	1552-4604
ISSN	0091-2700 ; 0021-9754
DOI	10.1002/jcph.933
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Article ; Online: Electrophysiological and ECG Effects of Perhexiline, a Mixed Cardiac Ion Channel Inhibitor, Evaluated in Nonclinical Assays and in Healthy Subjects.

Midei, Mark G / Darpo, Borje / Ayers, Greg / Brown, Randy / Couderc, Jean-Philippe / Daly, William / Ferber, Georg / Sager, Philip T / Camm, A John

Journal of clinical pharmacology

2021 Volume 61, Issue 12, Page(s) 1606–1617

Abstract: Perhexiline has been used to treat hypertrophic cardiomyopathy. In addition to its effect on carnitine-palmitoyltransferase-1, it has mixed ion channel effects through inhibition of several cardiac ion currents. Effects on cardiac ion channels expressed ... ...

Abstract	Perhexiline has been used to treat hypertrophic cardiomyopathy. In addition to its effect on carnitine-palmitoyltransferase-1, it has mixed ion channel effects through inhibition of several cardiac ion currents. Effects on cardiac ion channels expressed in mammalian cells were assayed using a manual patch-clamp technique, action potential duration (APD) was measured in ventricular trabeculae of human donor hearts, and electrocardiogram effects were evaluated in healthy subjects in a thorough QT (TQT) study. Perhexiline blocked several cardiac ion currents at concentrations within the therapeutic range (150-600 ng/mL) with IC
MeSH term(s)	Adult ; Calcium Channel Blockers/pharmacology ; Cross-Over Studies ; Dose-Response Relationship, Drug ; Double-Blind Method ; Electrocardiography/drug effects ; Female ; Humans ; Male ; Perhexiline/pharmacology ; Pilot Projects ; Young Adult
Chemical Substances	Calcium Channel Blockers ; Perhexiline (KU65374X44)
Language	English
Publishing date	2021-07-20
Publishing country	England
Document type	Journal Article ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
ZDB-ID	188980-1
ISSN	1552-4604 ; 0091-2700 ; 0021-9754
ISSN (online)	1552-4604
ISSN	0091-2700 ; 0021-9754
DOI	10.1002/jcph.1934
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Article ; Online: Response to Letter to the Editor by Blankfield regarding "Assessment of drug-induced increases in blood pressure during drug development: report from the Cardiac Safety Research Consortium.".

White, William B / Sager, Philip T

American heart journal

2013 Volume 166, Issue 3, Page(s) e11

MeSH term(s)	Blood Pressure/drug effects ; Humans
Language	English
Publishing date	2013-09
Publishing country	United States
Document type	Comment ; Letter
ZDB-ID	80026-0
ISSN	1097-6744 ; 0002-8703
ISSN (online)	1097-6744
ISSN	0002-8703
DOI	10.1016/j.ahj.2013.06.007
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