Trial · NCT05225805
Study to Assess the Safety and PK of Oral and IV Xenleta in Adults With Cystic Fibrosis
NCT05225805, Phase 1, Completed, Nabriva Therapeutics AG; results first posted 2024-06-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study to Assess the Safety and PK of Oral and IV Xenleta in Adults With Cystic Fibrosis. Trials, record NCT05225805. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05225805
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Assess the Safety and PK of Oral and IV Xenleta in Adults With Cystic Fibrosis
- NCT number
- NCT05225805
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 13 participants, actual
- Lead sponsor
- Nabriva Therapeutics AG
- Conditions
- Cystic Fibrosis
- Interventions
- Lefamulin
- First posted
- 2022-02-07
- Last updated
- 2024-06-17
- Results first posted
- 2024-06-17
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Median for Lefamulin and Its Main Metabolite BC-8041 for PK Plasma Parameter Tmax in Cystic Fibrosis (CF) Patients. | Pre-dose, 0.5 hr, 1 hr, 1.5 hrs, 2 hrs, 4 hrs, 8 hrs, 12 hrs & 24 hrs Post-dose | 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. |
| Primary | The Key Geometric Mean for Lefamulin and Its Main Metabolite BC-8041 for PK Plasma Parameter Cmax in CF Patients. | Pre-dose, 0.5 hr, 1 hr, 1.5 hrs, 2 hrs, 4 hrs, 8 hrs, 12 hrs & 24 hrs Post-dose | Appropriate non-compartmental techniques will be used to obtain estimates for the PK parameter Cmax in plasma for lefamulin and its metabolite BC-8041. Maximum observed plasma concentration (Cmax) Cmax was determined by direct inspection of the concentration versus time data by WinNonlin. |
| Primary | The Key Geometric Mean for Lefamulin and Its Main Metabolite BC-8041 for PK Plasma Parameter AUC(0-last) in CF Patients. | Pre-dose, 0.5 hr, 1 hr, 1.5 hrs, 2 hrs, 4 hrs, 8 hrs, 12 hrs & 24 hrs Post-dose | Appropriate non-compartmental techniques will be used to obtain estimates for the PK parameter (AUC0-last) in plasma for lefamulin and its metabolite BC-8041. AUC calculations will be performed using the linear/log trapezoidal rule. AUC0-last will be calculated between t0hr and the last measurable concentration. Area under the drug concentration curve from time zero (0 h) to 24 h (AUC0-last) |
| Primary | The Key Geometric Mean for Lefamulin and Its Main Metabolite BC-8041 for PK Plasma Parameter AUC(0-inf) in CF Patients. | Pre-dose, 0.5 hr, 1 hr, 1.5 hrs, 2 hrs, 4 hrs, 8 hrs, 12 hrs & 24 hrs Post-dose | Appropriate non-compartmental techniques will be used to obtain estimates for PK parameter AUC(0-inf) in plasma for lefamulin and its metabolite BC-8041. AUC calculations will be performed using the linear/log trapezoidal rule. AUC(0-inf) will be will be calculated between t0hr and infinity. Area under the drug concentration curve from time zero (0 h) to infinity (AUC(0-inf) |
| Primary | The Key Geometric Mean for Lefamulin and Its Main Metabolite BC-8041 for PK Plasma Parameter t1/2 in CF Patients. | Pre-dose, 0.5 hr, 1 hr, 1.5 hrs, 2 hrs, 4 hrs, 8 hrs, 12 hrs & 24 hrs Post-dose | Appropriate non-compartmental techniques will be used to obtain estimates for thr PK parameter t1/2 in plasma for lefamulin and its metabolite BC-8041. Apparent elimination half-life calculated as ln(2)/ke (t½) |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Median for Lefamulin and Its Main Metabolite BC-8041 for PK Plasma Parameter Tmax in Cystic Fibrosis (CF) Patients. | Pre-dose, 0.5 hr, 1 hr, 1.5 hrs, 2 hrs, 4 hrs, 8 hrs, 12 hrs & 24 hrs Post-dose | Pharmacokinetic (PK) Population: All 13 adult subjects completed both periods of the study. Plasma samples from 13 subjects were analyzed for lefamulin and BC-8041. | hours | MEDIAN |
| PRIMARY | The Key Geometric Mean for Lefamulin and Its Main Metabolite BC-8041 for PK Plasma Parameter Cmax in CF Patients. | Pre-dose, 0.5 hr, 1 hr, 1.5 hrs, 2 hrs, 4 hrs, 8 hrs, 12 hrs & 24 hrs Post-dose | Pharmacokinetic (PK) Population: All 13 adult subjects completed both periods of the study. Plasma samples from 13 subjects were analyzed for lefamulin and BC-8041. | mg/L | GEOMETRIC_MEAN |
| PRIMARY | The Key Geometric Mean for Lefamulin and Its Main Metabolite BC-8041 for PK Plasma Parameter AUC(0-last) in CF Patients. | Pre-dose, 0.5 hr, 1 hr, 1.5 hrs, 2 hrs, 4 hrs, 8 hrs, 12 hrs & 24 hrs Post-dose | Pharmacokinetic (PK) Population: All 13 adult subjects completed both periods of the study. Plasma samples from 13 subjects were analyzed for lefamulin and BC-8041. | mg·h/L | GEOMETRIC_MEAN |
| PRIMARY | The Key Geometric Mean for Lefamulin and Its Main Metabolite BC-8041 for PK Plasma Parameter AUC(0-inf) in CF Patients. | Pre-dose, 0.5 hr, 1 hr, 1.5 hrs, 2 hrs, 4 hrs, 8 hrs, 12 hrs & 24 hrs Post-dose | Pharmacokinetic (PK) Population: All 13 adult subjects completed both periods of the study. Plasma samples from 13 subjects were analyzed for lefamulin and BC-8041. | mg·h/L | GEOMETRIC_MEAN |
| PRIMARY | The Key Geometric Mean for Lefamulin and Its Main Metabolite BC-8041 for PK Plasma Parameter t1/2 in CF Patients. | Pre-dose, 0.5 hr, 1 hr, 1.5 hrs, 2 hrs, 4 hrs, 8 hrs, 12 hrs & 24 hrs Post-dose | Pharmacokinetic (PK) Population: All 13 adult subjects completed both periods of the study. Plasma samples from 13 subjects were analyzed for lefamulin and BC-8041. | hours | GEOMETRIC_MEAN |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Median for Lefamulin and Its Main Metabolite BC-8041 for PK Plasma Parameter Tmax in Cystic Fibrosis (CF) Patients. | Lefamulin Oral Treatment | Lefamulin | 2.00 | Full Range 0.983 to 3.900 | hours |
| The Median for Lefamulin and Its Main Metabolite BC-8041 for PK Plasma Parameter Tmax in Cystic Fibrosis (CF) Patients. | Lefamulin IV Treatment | Lefamulin | 0.583 | Full Range 0.500 to 1.717 | hours |
| The Median for Lefamulin and Its Main Metabolite BC-8041 for PK Plasma Parameter Tmax in Cystic Fibrosis (CF) Patients. | Lefamulin Oral Treatment | Lefamulin metabolite BC-8041 | 1.517 | Full Range 1.017 to 4.017 | hours |
| The Median for Lefamulin and Its Main Metabolite BC-8041 for PK Plasma Parameter Tmax in Cystic Fibrosis (CF) Patients. | Lefamulin IV Treatment | Lefamulin metabolite BC-8041 | 1.500 | Full Range 0.933 to 1.817 | hours |
| The Key Geometric Mean for Lefamulin and Its Main Metabolite BC-8041 for PK Plasma Parameter Cmax in CF Patients. | Lefamulin Oral Treatment | Lefamulin | 1.314 | Geometric Coefficient of Variation 0.308 | mg/L |
| The Key Geometric Mean for Lefamulin and Its Main Metabolite BC-8041 for PK Plasma Parameter Cmax in CF Patients. | Lefamulin IV Treatment | Lefamulin | 1.924 | Geometric Coefficient of Variation 0.417 | mg/L |
| The Key Geometric Mean for Lefamulin and Its Main Metabolite BC-8041 for PK Plasma Parameter Cmax in CF Patients. | Lefamulin Oral Treatment | Lefamulin Metabolite BC-8041 | 0.351 | Geometric Coefficient of Variation 0.417 | mg/L |
| The Key Geometric Mean for Lefamulin and Its Main Metabolite BC-8041 for PK Plasma Parameter Cmax in CF Patients. | Lefamulin IV Treatment | Lefamulin Metabolite BC-8041 | 0.030 | Geometric Coefficient of Variation 0.470 | mg/L |
| The Key Geometric Mean for Lefamulin and Its Main Metabolite BC-8041 for PK Plasma Parameter AUC(0-last) in CF Patients. | Oral Treatment | Lefamulin | 6.881 | Geometric Coefficient of Variation 0.380 | mg·h/L |
| The Key Geometric Mean for Lefamulin and Its Main Metabolite BC-8041 for PK Plasma Parameter AUC(0-last) in CF Patients. | IV Treatment | Lefamulin | 6.220 | Geometric Coefficient of Variation 0.286 | mg·h/L |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Group A (IV-Oral) | 6 | |
| Overall Study | STARTED | Group B (Oral-IV) | 7 | |
| Overall Study | COMPLETED | Group A (IV-Oral) | 6 | |
| Overall Study | COMPLETED | Group B (Oral-IV) | 7 | |
| Overall Study | NOT COMPLETED | Group A (IV-Oral) | 0 | |
| Overall Study | NOT COMPLETED | Group B (Oral-IV) | 0 |
Source ClinicalTrials.gov
Adverse events24
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhea | Gastrointestinal disorders | Lefamulin Oral Treatment | 2 | 13 | |
| other | Diarrhea | Gastrointestinal disorders | Lefamulin IV Treatment | 0 | 13 | |
| other | Diarrhea | Gastrointestinal disorders | Total | 2 | 13 | |
| other | Nausea | Gastrointestinal disorders | Lefamulin Oral Treatment | 2 | 13 | |
| other | Nausea | Gastrointestinal disorders | Lefamulin IV Treatment | 1 | 13 | |
| other | Nausea | Gastrointestinal disorders | Total | 2 | 13 | |
| other | Vomiting | Gastrointestinal disorders | Lefamulin Oral Treatment | 1 | 13 | |
| other | Vomiting | Gastrointestinal disorders | Lefamulin IV Treatment | 0 | 13 | |
| other | Vomiting | Gastrointestinal disorders | Total | 1 | 13 | |
| other | Infusion site erythema | General disorders | Lefamulin Oral Treatment | 0 | 13 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Lefamulin Oral Treatment | 0 | 13 |
| Total, all-cause mortality | Lefamulin IV Treatment | 0 | 13 |
| Total, all-cause mortality | Total | 0 | 13 |
| Total, other adverse events | Lefamulin Oral Treatment | 4 | 13 |
| Total, other adverse events | Lefamulin IV Treatment | 4 | 13 |
| Total, other adverse events | Total | 6 | 13 |
| Total, serious adverse events | Lefamulin Oral Treatment | 0 | 13 |
| Total, serious adverse events | Lefamulin IV Treatment | 0 | 13 |
| Total, serious adverse events | Total | 0 | 13 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 38195348 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05225805
GET https://conductscience.org/api/trials/v1/NCT05225805/events?page=2