Study to Compare the Pharmacokinetics, Safety and Tolerability of the Pediatric and Adult Branaplam Formulation in Healthy Adults and the Effect of Food on the Latter.

Healthy Volunteers Clinical Trial

Official title: Randomized, Single-dose, Open-label, Two-part, Two-period, Cross-over Study to Compare the Pharmacokinetics, Safety and Tolerability of the Pediatric With an Adult Formulation of Branaplam and to Investigate the Adult Formulation in Fed and Fasted State in Healthy Participants

Status Terminated

Clinical Trial Summary

This is a Phase 1 study designed to assess the relative bioavailability (BA), safety and tolerability and PK of the pediatric and adult formulations of branaplam.

Clinical Trial Description

This study is to compare the pharmacokinetics, safety and tolerability of the pediatric and adult branaplam formulation in healthy adults. The study will also clarify if dosing with food can affect the PK of the adult formulation in order to guide recommendations on dosing relative to meals in subsequent studies. It is two-part, two-period, cross-over study in healthy participants which means that participants will receive both doses and take the treatment with and without food. The total study duration for each participant is expected to be up to approximately 88 days, including the Screening period and safety FU call. Participants will be required to be stay at the site overnight for 6 days during each period to receive dose and have multiple blood draws. ;

Related Conditions & MeSH terms

• Healthy Volunteers

• NCT number: NCT05330286
• Study type: Interventional
• Source: Novartis
• Status: Terminated
• Phase: Phase 1
• Start date: April 13, 2022
• Completion date: August 19, 2022