Study to Assess the Safety and PK of Oral and IV Xenleta in Adults With Cystic Fibrosis

Phase 1 Completed 13 enrolled Nabriva Therapeutics AG

RandomizedCrossoverOpen-labelOther

Summary

This study is intended to assess the pharmacokinetic (PK) and safety of a single dose of IV and oral formulations of lefamulin in adults with cystic fibrosis (CF).

Timeline

Start: 2022-03-01
Primary completion: 2022-09-20
Completion: 2023-01-13

Publications

Sawicki GS, Wicha WW, Hiley TS, Close NC, Gelone SP, Guico-Pabia CJ. Safety and Pharmacokinetics Following Oral or Intravenous Lefamulin in Adults With Cystic Fibrosis. Clin Ther. 2024 Feb;46(2):96-103. doi: 10.1016/j.clinthera.2023.12.002. Epub 2024 Jan 8.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Lefamulin	Other / unclassified	150 mg	Intravenous
Subject	Lefamulin	Other / unclassified	600 mg	Intravenous

Study to Assess the Safety and PK of Oral and IV Xenleta in Adults With Cystic Fibrosis

Summary

Timeline

Publications

Drugs

Indications