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.

Phase 1 Terminated 9 enrolled Novartis Pharmaceuticals

RandomizedCrossoverDouble-blindTreatment

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.

Timeline

Start: 2022-04-13
Primary completion: 2022-08-19
Completion: 2022-08-19

Outcome

Outcome not reported

Stopped: “The compound is no longer suitable for further clinical development due to a safety finding in a later phase program.”

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Branaplam	Small molecule	—	Oral

Indications

No indication recorded.