At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 13 enrolled
Drug / intervention
Lefamulindrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 1, Open-Label, Randomized, Crossover Study to Assess the Safety and Pharmacokinetics Following Single Doses of Oral and Intravenous Xenleta (Lefamulin) in Adult Patients With Cystic Fibrosis
In Brief
A Phase 1 clinical trial evaluating Lefamulin for Cystic Fibrosis. Completed, enrolled 13 participants across 6 sites.
Detailed 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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCystic Fibrosis
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
20222023202420252026
First PostedFeb 2022
Enrollment StartMar 2022
Primary CompletionSep 2022
Study CompletionJan 2023
TodayJul 2026
First PostedFeb 7, 2022
Enrollment StartMar 1, 2022
Primary CompletionSep 20, 2022
Study CompletionJan 13, 2023
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 4.4 years ago
Interventions
Lefamulindrug
Antibiotic