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NCT05225805 · ClinicalTrials.gov registry record · Phase 1
Study to Assess the Safety and PK of Oral and IV Xenleta in Adults With Cystic Fibrosis
A Phase 1 study, sponsored by Nabriva Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 13
- Enrollment target
NCT05225805: Completed Phase 1 study, sponsored by Nabriva Therapeutics.
NCT05225805 is a Phase 1 study that has completed, run by Nabriva Therapeutics. The registered enrollment target is 13 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05225805, a Phase 1 study, has completed, sponsored by Nabriva Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 13 participants
- Enrollment target
Study 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).
Primary Outcome
Appropriate non-compartmental techniques were used to obtain estimates for the PK parameter Tmax in plasma for lefamulin and its metabolite BC-8041. Time to reach maximum plasma concentration of lefamulin following drug administration (Tmax) Tmax will be determined by direct inspection of the concentration versus time data by WinNonlin.
Interventions
- DRUG Lefamulin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2022-03-01 |
| Est. Completion | 2023-01-13 |
| Phase | Phase 1 |
What the finished NCT05225805 record still lists
NCT05225805 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% lower).
The record links to 0 conditions, and to 1 intervention - of which Lefamulin is the first listed.
NCT05225805 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05225805 about?
NCT05225805 is a clinical study titled "Study to Assess the Safety and PK of Oral and IV Xenleta in Adults With Cystic Fibrosis". 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).
What is the current status of trial NCT05225805?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 13 participants. The study started on 2022-03-01. Estimated completion is 2023-01-13.
What interventions are being tested in trial NCT05225805?
The interventions under investigation include: Lefamulin (DRUG).
Who is sponsoring clinical trial NCT05225805?
This trial is sponsored by Nabriva Therapeutics, which has 6 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05225805's enrollment target sits among peer trials
13 1847th of 2000 higher than 149 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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