Clinical Evaluation of Potential Interaction Between Bemnifosbuvir and Ruzasvir With an Assessment of Food Effect: Results of a Phase 1 Study in Healthy Participants DOI Creative Commons

Xiao‐Jian Zhou,

Gaetano Morelli,

Maureen Montrond

et al.

Clinical Pharmacology in Drug Development, Journal Year: 2025, Volume and Issue: unknown

Published: April 24, 2025

Abstract A combination of nucleotide hepatitis C virus (HCV) nonstructural protein (NS) 5B and 5A inhibitors is a preferred standard care for treating chronic HCV. Bemnifosbuvir novel oral guanosine prodrug with potent pan‐genotypic inhibitory activity against HCV NS5B. Ruzasvir, small‐molecule NS5A inhibitor, has demonstrated improved anti‐HCV compared first‐generation inhibitors. Clinical studies have favorable efficacy safety bemnifosbuvir ruzasvir in other NS5B inhibitors, respectively. Phase 1 study healthy participants was conducted to assess the drug‐drug interaction potential between ruzasvir, as well food effects following coadministration both compounds. Under fasted conditions, peak, trough, total exposure its metabolites were increased upon (by maximum 33% vs alone), whereas corresponding values decreased 26% alone). Food delayed peak drugs up 2 hours) while increasing their by 63%. No serious adverse events or premature drug discontinuations reported. Overall, results support further evaluation therapy

Language: Английский

Clinical Evaluation of Potential Interaction Between Bemnifosbuvir and Ruzasvir With an Assessment of Food Effect: Results of a Phase 1 Study in Healthy Participants DOI Creative Commons

Xiao‐Jian Zhou,

Gaetano Morelli,

Maureen Montrond

et al.

Clinical Pharmacology in Drug Development, Journal Year: 2025, Volume and Issue: unknown

Published: April 24, 2025

Abstract A combination of nucleotide hepatitis C virus (HCV) nonstructural protein (NS) 5B and 5A inhibitors is a preferred standard care for treating chronic HCV. Bemnifosbuvir novel oral guanosine prodrug with potent pan‐genotypic inhibitory activity against HCV NS5B. Ruzasvir, small‐molecule NS5A inhibitor, has demonstrated improved anti‐HCV compared first‐generation inhibitors. Clinical studies have favorable efficacy safety bemnifosbuvir ruzasvir in other NS5B inhibitors, respectively. Phase 1 study healthy participants was conducted to assess the drug‐drug interaction potential between ruzasvir, as well food effects following coadministration both compounds. Under fasted conditions, peak, trough, total exposure its metabolites were increased upon (by maximum 33% vs alone), whereas corresponding values decreased 26% alone). Food delayed peak drugs up 2 hours) while increasing their by 63%. No serious adverse events or premature drug discontinuations reported. Overall, results support further evaluation therapy

Language: Английский

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