NCT05330286

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.

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	LMI070	oral solution
DRUG	LMI070	Oral solution
DRUG	LMI070	Oral solution given in fasted state
DRUG	LMI070	Oral solution given in fed state

Timeline

• Start date: 2022-04-13
• Primary completion: 2022-08-19
• Completion: 2022-08-19
• First posted: 2022-04-15
• Last updated: 2023-07-14

Locations

1 site across 1 country: United Kingdom