CFDB - Cystic Fibrosis DataBase

ongoing trials trial from www.clinicaltrials.gov

Proof-of-concept Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of SION-719 When Added to Trikafta

Study design (if review, criteria of inclusion for studies)

Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT

Participants

ADULT, OLDER_ADULT with CF

Interventions

DRUG: SION-719|DRUG: Placebo-to-match SION-719

Outcome measures

Adverse events [Safety and Tolerability] when SION-719 is administered to people with cystic fibrosis (CF) who are taking a standard stable dose of physician-prescribed Trikafta

Keywords: CFTR Modulators; Genetic Predisposition to Disease; pharmacological_intervention; placebo; VX-770; VX-661; ivacaftor; Aminophenols; tezacaftor; VX-445; elexacaftor; Trikafta; SION-719; CFTR NBD1 inhibitors;