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Comparison of the Pharmacokinetics of the Phase II and Phase III Capsule Formulations of Selumetinib and the Effects of Food on Exposure: Results From Two Randomized Crossover Trials in Healthy Male Subjects.

Author: CantariniMireille, DymondAngela W, HoltDavid, LisbonEleanor, MartinPaul, McBrideEileen, SoKaren, TomkinsonHelen

Clinical Trial, Phase IIA Phase II trial is a trial that further evaluates the efficacy and safety of a new drug or treatment, whose safety has been confirmed to some extent in a Phase I trial, in a small number of patients.
Clinical Trial, Phase IIIA Phase III trial is a trial that further rigorously verifies the efficacy and safety of a new drug or treatment, whose efficacy and safety have been confirmed in a Phase II trial, in a large number of patients, and evaluates whether it is superior to existing treatments.
Comparative StudyResearch that compares multiple groups/interventions to determine differences/similarities in outcomes/characteristics.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.

Overview

Selumetinib, a potent inhibitor of mitogen-activated protein kinase 1/2, has shown promise in treating various cancers. This study evaluated the safety and efficacy of the Phase III formulation of selumetinib capsules in healthy subjects.
Paper Details　
Original Abstract of the Article :
Selumetinib (AZD6244, ARRY-142886), an oral, potent, and highly selective mitogen-activated protein kinase 1/2 inhibitor with a short half-life, has shown activity across various tumor types. Before initiation of Phase III trials, the site, scale, and color (hypromellose shell from white [Phase II] ...See full text at original site
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引用元：
https://doi.org/10.1016/j.clinthera.2017.08.022

データ提供：米国国立医学図書館（NLM）

Selumetinib: Evaluating Pharmacokinetic Changes

The field of [cancer treatment] involves a continuous effort to improve the efficacy and safety of existing drugs. This study examines the [pharmacokinetic changes] associated with a [modified formulation] of [selumetinib], an oral inhibitor of [mitogen-activated protein kinase 1/2]. The study compared the pharmacokinetic profiles of the [Phase II] and [Phase III] capsule formulations of selumetinib in healthy subjects. The research found that the [Phase III] formulation resulted in [comparable exposure] to the [Phase II] formulation, indicating that the modification did not significantly alter the drug's pharmacokinetic profile. The study also evaluated the [impact of food] on selumetinib exposure, finding that food consumption did not significantly affect the drug's absorption.

A Consistent Journey: Selumetinib's Pharmacokinetic Profile

The study's findings provide reassurance that the [modified formulation] of selumetinib does not significantly alter its [pharmacokinetic profile]. This consistency is important for ensuring the [predictability] of the drug's efficacy and safety.

Selumetinib: A Trail Through the Desert of Cancer Treatment

The search for effective and safe cancer treatments continues. This study evaluates the pharmacokinetic profile of a [modified formulation] of selumetinib. The study's findings provide valuable information to ensure the consistent efficacy and safety of this drug.

Dr. Camel's Conclusion

This study is a journey through the desert of drug development, exploring the pharmacokinetic profile of a modified formulation of selumetinib. The researchers found that the modified formulation did not significantly alter the drug's pharmacokinetic profile, indicating that the changes made to the formulation were successful in maintaining the drug's effectiveness and safety. Like a camel navigating a vast and challenging landscape, we must continue to refine our drug development approaches to ensure the best possible outcomes for our patients.

Date :
  1. Date Completed 2018-05-15
  2. Date Revised 2022-03-31
Further Info :

Pubmed ID

28985960

DOI: Digital Object Identifier

10.1016/j.clinthera.2017.08.022

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Article Analysis
・Effects of selumetinib・Effects of selumetinib
SNS
PICO Info
in preparation
Languages

English

Positive IndicatorAn AI analysis index that serves as a benchmark for how positive the results of the study are. Note that it is a benchmark and requires careful interpretation and consideration of different perspectives.

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