Effect of esomeprazole, a proton pump inhibitor on the pharmacokinetics of sonidegib in healthy volunteers

Zhou, Jocelyn; Quinlan, Michelle; Glenn, Kelli; Boss, Hildegard; Picard, Franck; Castro, Henry; Sellami, Dalila

doi:10.1111/bcp.13038

Cited by 16 publications

(14 citation statements)

References 16 publications

(17 reference statements)

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“…CK elevation was the most common grade 3/4 event, occurring in 6% of patients taking the 200 mg dose; women show a lower risk of CK abnormality than men 52. Furthermore, CK elevations were observed at low doses in Japanese patients, which resulted in their lower MTD of sonidegib 48,49. Serious adverse events, including rhabdomyolysis and very high CK, were very rarely associated with sonidegib.…”

Section: Safety Tolerability and Adverse Effects Of Sonidegibmentioning

confidence: 99%

Sonidegib: mechanism of action, pharmacology, and clinical utility for advanced basal cell carcinomas

Jain¹,

Song²,

Xie³

2017

OTT

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The Hedgehog (Hh) pathway is critical for cell differentiation, tissue polarity, and stem cell maintenance during embryonic development, but is silent in adult tissues under normal conditions. However, aberrant Hh signaling activation has been implicated in the development and promotion of certain types of cancer, including basal cell carcinoma (BCC), medulloblastoma, and gastrointestinal cancers. In 2015, the US Food and Drug Administration (FDA) approved sonidegib, a smoothened (SMO) antagonist, for treatment of advanced BCC (aBCC) after a successful Phase II clinical trial. Sonidegib, also named Odomzo, is the second Hh signaling inhibitor approved by the FDA to treat BCCs following approval of the first SMO antagonist vismodegib in 2012. What are the major features of sonidegib (mechanism of action; metabolic profiles, clinical efficacy, safety, and tolerability profiles)? Will the sonidegib experience help other clinical trials using Hh signaling inhibitors in the future? In this review, we will summarize current understanding of BCCs and Hh signaling. We will focus on sonidegib and its use in the clinic, and we will discuss ways to improve its clinical application in cancer therapeutics.

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Section: Safety Tolerability and Adverse Effects Of Sonidegibmentioning

confidence: 99%

Sonidegib: mechanism of action, pharmacology, and clinical utility for advanced basal cell carcinomas

Jain¹,

Song²,

Xie³

2017

OTT

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“…All analyses were descriptive [13]. The stepwise selection was done in SAS 9.2 using procedure GLMSELECT with default model selection criterion (i.e.…”

Section: Competing Interestsmentioning

confidence: 99%

“…Schwarz Bayesian Information criterion) and additional options (i.e. intercept suppressed and AUC(0,2.5 days) forced to be included in the model) [13].…”

Section: Competing Interestsmentioning

confidence: 99%

“…To account for multiple comparisons, a reduced two-sided P value of 0.01 was used to indicate statistical significance for post hoc comparisons [13].…”

Section: Competing Interestsmentioning

confidence: 99%

“…AUC inf [area under curve from time zero to infinity], CL/F [apparent oral clearance], Vz/F [apparent volume of distribution], and t 1/2 [elimination half-life]) were not part of the analysis [13].…”

mentioning

confidence: 99%

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How publication guidelines for clinical pharmacology trials may help to accelerate knowledge transfer

Ring

Breithaupt-Grögler²

2018

Brit J Clinical Pharma

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Keywords clinical pharmacology, clinical trials, drug development, evidence based medicine Reports and publications on late phase clinical trials and other medical research are nowadays highly regulated, in particular confirmatory trials aiming to demonstrate the efficacy and safety of health technologies. This does not only affect the actual submission of drug dossiers to health authorities to achieve marketing authorisation. It already starts with the registration of clinical trials in publicly available registers at the time when the study protocols have been finalised and extends to requirements and guidelines for publications in medical journals [1].The key objective of these regulations is to achieve transparency how the research was actually planned, performed and analysed and which decisions had been made to accommodate unplanned situations. Thereby allowing the internal and external validity of the trial results to be judged, so that the interpretations and conclusions are comprehensible for readers. The targeted audience includes reviewers who are to decide whether an intended publication is fit to be presented to the wider scientific community. Thus, convincing the reader of the quality of one's research means convincing the reviewer first.Accordingly, within the EQUATOR network (Enhancing the QUAlity and Transparency Of health Research), a large number of reporting recommendations have been developed. Starting with the CONSORT statement on confirmatory randomised parallel group clinical trials [2], there are now extensions for trials with particular designs (e.g. equivalence trials or N-of-1 trials), but also more general fields like systematic reviews (PRISMA) or diagnostic/prognostic studies. So it seems that most of the medical research has its own reporting guideline.Interestingly, these guidelines do not cover clinical pharmacology studies. There are some extensions that might appear to be closely related, such as the "reporting withinperson randomised trials," or the "reporting randomised pilot and feasibility trials," but a closer view clarifies that their overlap with clinical pharmacology is rather minor. For example, the "within-person trials" guideline does not cover conventional crossover trials (with sequential treatments), but trials in which two treatments are applied simultaneously to the same person (e.g. to both eyes, to teeth or to different places of the skin). The "pilot and feasibility trial" guideline focuses on the practical development of the trial design and its implementation for a confirmatory trial, rather than on the development of a pharmacological treatment in Phase I-IIa regarding pharmacokinetics, pharmacodynamics and proof of principle with "surrogates" like biomarkers.In a BJCP editorial about 2 years ago [3], it was asked whether clinical pharmacology would benefit from having such guidelines. On one hand, clinical pharmacology trials are very diverse, sometimes not randomised, with quite different objectives, designs, and analysis methods. On the other hand, the ...

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Sonidegib

Dudzisz-Śledź¹

2021

New Therapies in Advanced Cutaneous Malignancies

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Effect of esomeprazole, a proton pump inhibitor on the pharmacokinetics of sonidegib in healthy volunteers

Cited by 16 publications

References 16 publications

Sonidegib: mechanism of action, pharmacology, and clinical utility for advanced basal cell carcinomas

Sonidegib: mechanism of action, pharmacology, and clinical utility for advanced basal cell carcinomas

How publication guidelines for clinical pharmacology trials may help to accelerate knowledge transfer

Sonidegib

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