Financiado en parte por TheraCryf PLC
A Phase 1 Randomized, Placebo-Controlled Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Enteric-Coated Stabilized Sulforaphane (SFX-01) in Male Participants
Clack G, Moore C, Ruston L, Wilson D, Koch A, Webb D, Mallard N
Advances in therapy · 5 citas
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Cómo se estudió
- Diseño
- Ensayo controlado aleatorizado (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Marcadores de salud y funcionamiento
- Consumo medido con
- No se indica
Quién lo pagó
- Financiación
- Financiado por la industria
- Empresa
- TheraCryf PLC
- Autores
- Al menos un autor declara un vínculo económico con la industria
Según 1 financiador declarado y la declaración de financiación del texto completo.
Publicación
- Publicado
- 2024-11-09 · Adv Ther · vol. 42 · número 1 · págs. 216–232
- Editorial
- Adis, Springer Healthcare
- Citado
- 9 citas · más que el 75% de estudios similares · 1.0× el promedio de su campo
- Referencias
- 38 trabajos
- Acceso
- Acceso abierto (revista híbrida) · CC-BY-NC
- Áreas de investigación
- Genomics, phytochemicals, and oxidative stress · Pharmacogenetics and Drug Metabolism · Drug Solubulity and Delivery Systems
- Palabras clave
- sulforaphane, isothiocyanates, enteric-coated tablets, pharmacokinetics, safety and tolerability, dose escalation, urinary excretion, dose proportionality, gastrointestinal adverse effects, healthy men
- MeSH
- humans, isothiocyanates, sulfoxides, anticarcinogenic agents, tablets, enteric-coated, double-blind method, dose-response relationship, drug, adult, middle aged, male, young adult
7 autores
- Glen Clack🇬🇧 · autor de correspondenciaEvgen Pharma (United Kingdom)
- Christopher Moore🇬🇧Boyds (United Kingdom)
- Linette Ruston
- David Wilson
- Annelize Koch
- Danielle Webb
- Nicholas Mallard
Resumen
El texto original del estudio, en el idioma en que se publicó.
Introduction
Sulforaphane (SFN) is a naturally occurring isothiocyanate associated with various health benefits, including reduced cancer risk, and has been extensively explored as a potential therapeutic. However, its inherent instability presents challenges in formulation, storage, and administration as a medicinal product. SFX-01 (Sulforadex®) is a patented synthetic form of d,l-SFN stabilized within a biologically inert alpha-cyclodextrin complex.
Methods
The safety, tolerability, and pharmacokinetics of an enteric-coated tablet formulation of SFX-01 were evaluated in a randomized, double-blind, placebo-controlled, dose-escalation study [300 mg once daily (46.2 mg SFN), 300 mg twice daily or 600 mg once daily (92.4 mg SFN)] over 7 days in healthy male participants.
Results
Treatment-emergent adverse events (TEAEs) occurred in 94% of participants who received SFX-01 and were most commonly gastrointestinal events, which were mild in severity and related to treatment. Following ingestion of SFX-01 tablets, SFN was rapidly absorbed, with a timescale consistent with the enteric coating, and subsequently metabolized. The observed peak blood concentration (Cmax) for the sum of SFN and metabolites (total thiol) across all treatment cohorts ranged from 0.43 to 2.12 µmol/L in 3-6 h. Cmax data were considered inconclusive with respect to dose-proportionality and there was minimal evidence of accumulation of SFN and metabolites. Urinary excretion of SFN and individual metabolites ranged from < 1 to 41%, and the proportion excreted did not appear to be influenced by the dose.
Conclusion
This study demonstrated the safety and tolerability of SFX-01 over 7 days and indicated that the pharmacokinetic behavior of SFX-01 enteric-coated tablets was in line with expectations.
Trial registration
European Union Drug Regulating Authorities Clinical Trials Database (EudraCT) number: 2022-001601-43; ISRCTN Study Registration number: ISRCTN9628565.
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial (CC BY-NC).
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