Cystic FibrosisPhase 1NCT05225805

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

A Phase 1 study testing Lefamulin in people with Cystic Fibrosis, run by Nabriva Therapeutics AG at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Cystic Fibrosis
What is being tested?: Lefamulin
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 13 participants
Where: 6 sitesUnited States
Study dates: 1 Mar 2022to 13 Jan 2023
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Signed informed consent.
Adult patients, ≥ 18 years of age.
Genetic confirmation of CF diagnosis by a report from a genetic test, such as "F508 deletion detected."
Weight > 40 kgs.
Forced expiration volume (FEV)1 > 40% predicted, as measured during the most recent evaluation.
Mentally and physically able to participate in the study as determined by the Investigator, ie, clinically stable with no significant changes in health status within 28 days prior to, and including, Day 1.

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Vital signs within the following ranges:
Tympanic temperature, < 38°C
Systolic blood pressure, 90 to 160 mmHg
Diastolic blood pressure, 50 to 90 mmHg
Heart rate < 100 beats per minute at rest
Respiration rate 12 to 20 breaths per minute
Oxygen saturation to be documented. No selection criteria; supplemental oxygen use is acceptable.
Negative beta-human chorionic gonadotropin (β-hCG) urine or serum pregnancy test for females of childbearing potential.
Willing to commit to acceptable methods of contraception as defined in the protocol.

Who cannot join

Known history of chronic liver or biliary disease, Gilbert's syndrome, or any of the following at Screening: aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2 x upper limit of normal (ULN), total bilirubin > 1.5 x ULN.
Prolonged baseline corrected QT interval corrected according to Fridericia (QTcF) defined as > 440 ms (females) and > 430 ms (males).
Family history or presence of prolonged QTc syndrome, Torsades de Pointes, or known conduction defects (eg, bundle branch block, atrioventricular block).
Use of Orkambi® (lumacaftor/ivacaftor) within 28 days prior to Day 1.
Use of cytochrome P450 (CYP)3A substrates that prolong the QT interval within 24 hours prior to Day 1.
Use of strong and moderate Cytochrome P450 (CYP3A) inducers or P-glycoprotein (P-gp) inducers within 28 days prior to Day 1.

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Use of strong inhibitors of CYP3A4 within 24 hours prior to Day 1.
Serum potassium level below the normal reference range at Screening.
Known allergy to pleuromutilin class of antibiotic or any of the excipients of the lefamulin formulations.
Consumption of grapefruit, grapefruit juice, grapefruit products, pomelo, or Seville oranges within 24 hours before Day 1.
Use of vaporized nicotine or cannabidiol products, smoking (regularly or intermittently) more than 5 cigarettes (or equivalent) per day, or any use of tobacco other than in cigarettes or cigars within 28 days of Day 1.
Positive blood test for hepatitis C, human immunodeficiency virus (HIV), or hepatitis B antigen or core antibody (indicating active infection).
Positive test for drugs of abuse or alcohol at Screening or Day 1 that cannot be satisfactorily supported by medical history.
Use of an investigational product within the 30 days prior to Day 1 (3 months prior to Day 1 if the study drug was a new chemical entity).
Difficulty swallowing tablets.
Females who are pregnant or breastfeeding.
Does not have suitable venous access for multiple venipuncture or cannulation.
Any medical, psychological, cognitive, social, or legal conditions that, in the opinion of the Investigator, would interfere with the patient's ability to give an informed consent and/or participate fully in the study.
Any other reason, in the opinion of the Investigator, the patient is unsuitable to participate.

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

United States6 sites

Boston Children's Hospital
Boston, Massachusetts, 02115
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Penn State University College of Medicine
Hershey, Pennsylvania, 17033
University of Kansas School of Medicine
Kansas City, Kansas, 66160
University of Utah
Salt Lake City, Utah, 84112
New York Medical College
Valhalla, New York, 10595

Other trials in United States

About this study

Official title: 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

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).

Read the detailed description

Staphylococcus aureus is one of the most common causative pathogens associated with exacerbations of CF. Current treatment guidelines for the management of exacerbations of CF caused by S. aureus recommend the use of unapproved antibacterial agents. Further, many of the recommended treatments can only be administered via the IV route and/or have limitations due to safety and tolerability. Lefamulin is a novel, first-in-class, IV and oral pleuromutilin antimicrobial agent that has been demonstrated to be highly potent against S. aureus, including Methicillin-resistant Staphylococcus aureus (MRSA) and strains obtained from patients with CF. Cystic fibrosis patients have altered drug distribution and elimination kinetics for many antimicrobials relative to patients without CF. While the advent of Cystic fibrosis transmembrane conductance regulator (protein) (CFTR) modulators has resulted in improved lung function and had a positive impact on the quality of life of CF patients, limited data have been published describing the impact of the concomitant use of CFTR modulators and commonly used antibacterial agents.

Conditions: Cystic Fibrosis
Being tested: Lefamulin
Medical subject headings: Cystic Fibrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LefamulinDrug
Also called BC-3781
Antibiotic

Study groups in NCT05225805
Study group	Role	What they receive
Group A	Experimental	Group A will receive one dose of 150 mg lefamulin IV followed by one dose of 600 mg lefamulin oral Receives: Drug: Lefamulin
Group B	Experimental	Group B will receive one dose of 600 mg lefamulin oral followed by one dose of 150 mg lefamulin IV Receives: Drug: Lefamulin

What is being measured

The primary outcome is the main question the study is designed to answer.

The Median for Lefamulin and Its Main Metabolite BC-8041 for PK Plasma Parameter Tmax in Cystic Fibrosis (CF) Patients.
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.
Measured: Pre-dose, 0.5 hr, 1 hr, 1.5 hrs, 2 hrs, 4 hrs, 8 hrs, 12 hrs & 24 hrs Post-dose
The Key Geometric Mean for Lefamulin and Its Main Metabolite BC-8041 for PK Plasma Parameter Cmax in CF Patients.
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.
Measured: Pre-dose, 0.5 hr, 1 hr, 1.5 hrs, 2 hrs, 4 hrs, 8 hrs, 12 hrs & 24 hrs Post-dose
The Key Geometric Mean for Lefamulin and Its Main Metabolite BC-8041 for PK Plasma Parameter AUC(0-last) in CF Patients.
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)
Measured: Pre-dose, 0.5 hr, 1 hr, 1.5 hrs, 2 hrs, 4 hrs, 8 hrs, 12 hrs & 24 hrs Post-dose
The Key Geometric Mean for Lefamulin and Its Main Metabolite BC-8041 for PK Plasma Parameter AUC(0-inf) in CF Patients.
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)
Measured: Pre-dose, 0.5 hr, 1 hr, 1.5 hrs, 2 hrs, 4 hrs, 8 hrs, 12 hrs & 24 hrs Post-dose
The Key Geometric Mean for Lefamulin and Its Main Metabolite BC-8041 for PK Plasma Parameter t1/2 in CF Patients.
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)
Measured: Pre-dose, 0.5 hr, 1 hr, 1.5 hrs, 2 hrs, 4 hrs, 8 hrs, 12 hrs & 24 hrs Post-dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Mar 202213 Jan 2023

First posted7 Feb 2022
Study start1 Mar 2022
Primary completion20 Sep 2022
Study completion13 Jan 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Cystic FibrosisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Model description: Open-label, Crossover Study
Masking: None (open label)
Enrolment: 13 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05225805
Sponsor's protocol ID: NAB-BC-3781-1014
Status last verified: Jan 2023
First submitted: 7 Jan 2022
Last updated: 17 Jun 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

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.
PubMed 38195348

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Cystic Fibrosis trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT05225805
Acronym / sponsor ID: NAB-BC-3781-1014
Conditions: Cystic Fibrosis
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 13 participants (actual)
Lead sponsor: Nabriva Therapeutics AGIndustry (pharma, biotech, devices)
Study start: 1 Mar 2022 (actual)
Primary completion: 20 Sep 2022 (actual)
Study completion: 13 Jan 2023 (actual)
First posted: 7 Feb 2022 (actual)
Results: Posted 17 Jun 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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).

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2
Model description: Open-label, Crossover Study

Arm	Type	Receives
Group A	Experimental	Drug: LefamulinGroup A will receive one dose of 150 mg lefamulin IV followed by one dose of 600 mg lefamulin oral
Group B	Experimental	Drug: LefamulinGroup B will receive one dose of 600 mg lefamulin oral followed by one dose of 150 mg lefamulin IV

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (15 listed)

Signed informed consent.
Adult patients, ≥ 18 years of age.
Genetic confirmation of CF diagnosis by a report from a genetic test, such as "F508 deletion detected."
Weight > 40 kgs.
Forced expiration volume (FEV)1 > 40% predicted, as measured during the most recent evaluation.

Key exclusion criteria (19 listed)

Known history of chronic liver or biliary disease, Gilbert's syndrome, or any of the following at Screening: aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2 x upper limit of normal (ULN), total bilirubin > 1.5 x ULN.
Prolonged baseline corrected QT interval corrected according to Fridericia (QTcF) defined as > 440 ms (females) and > 430 ms (males).
Family history or presence of prolonged QTc syndrome, Torsades de Pointes, or known conduction defects (eg, bundle branch block, atrioventricular block).
Use of Orkambi® (lumacaftor/ivacaftor) within 28 days prior to Day 1.
Use of cytochrome P450 (CYP)3A substrates that prolong the QT interval within 24 hours prior to Day 1.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
LefamulinAlso: BC-3781Antibiotic	Drug	Group A, Group B

Primary outcome

The Median for Lefamulin and Its Main Metabolite BC-8041 for PK Plasma Parameter Tmax in Cystic Fibrosis (CF) Patients.
Time frame: 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.
The Key Geometric Mean for Lefamulin and Its Main Metabolite BC-8041 for PK Plasma Parameter Cmax in CF Patients.
Time frame: 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.
The Key Geometric Mean for Lefamulin and Its Main Metabolite BC-8041 for PK Plasma Parameter AUC(0-last) in CF Patients.
Time frame: 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)
The Key Geometric Mean for Lefamulin and Its Main Metabolite BC-8041 for PK Plasma Parameter AUC(0-inf) in CF Patients.
Time frame: 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)
The Key Geometric Mean for Lefamulin and Its Main Metabolite BC-8041 for PK Plasma Parameter t1/2 in CF Patients.
Time frame: 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)

Results and safety

Results posted to the registry on 17 Jun 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group A (IV-Oral)	6	6
Group B (Oral-IV)	7	7

Primary outcome: The Median for Lefamulin and Its Main Metabolite BC-8041 for PK Plasma Parameter Tmax in Cystic Fibrosis (CF) Patients.

Time frame: Pre-dose, 0.5 hr, 1 hr, 1.5 hrs, 2 hrs, 4 hrs, 8 hrs, 12 hrs & 24 hrs Post-dose. Median (Full Range). Unit: hours

Measure	Lefamulin Oral Treatment n = 13	Lefamulin IV Treatment n = 13
Lefamulin	2.00 (0.983 to 3.900)	0.583 (0.500 to 1.717)
Lefamulin metabolite BC-8041	1.517 (1.017 to 4.017)	1.500 (0.933 to 1.817)

Population analysed: 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.

Primary outcome: The Key Geometric Mean for Lefamulin and Its Main Metabolite BC-8041 for PK Plasma Parameter Cmax in CF Patients.

Time frame: Pre-dose, 0.5 hr, 1 hr, 1.5 hrs, 2 hrs, 4 hrs, 8 hrs, 12 hrs & 24 hrs Post-dose. Geometric mean (Geometric Coefficient of Variation). Unit: mg/L

Measure	Lefamulin Oral Treatment n = 13	Lefamulin IV Treatment n = 13
Lefamulin	1.314 (0.308)	1.924 (0.417)
Lefamulin Metabolite BC-8041	0.351 (0.417)	0.030 (0.470)

Population analysed: 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.

Primary outcome: The Key Geometric Mean for Lefamulin and Its Main Metabolite BC-8041 for PK Plasma Parameter AUC(0-last) in CF Patients.

Time frame: Pre-dose, 0.5 hr, 1 hr, 1.5 hrs, 2 hrs, 4 hrs, 8 hrs, 12 hrs & 24 hrs Post-dose. Geometric mean (Geometric Coefficient of Variation). Unit: mg·h/L

Measure	Oral Treatment n = 13	IV Treatment n = 13
Lefamulin	6.881 (0.380)	6.220 (0.286)
Lefamulin Metabolite BC-8041	1.990 (0.442)	0.232 (0.536)

Population analysed: 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.

Primary outcome: The Key Geometric Mean for Lefamulin and Its Main Metabolite BC-8041 for PK Plasma Parameter AUC(0-inf) in CF Patients.

Time frame: Pre-dose, 0.5 hr, 1 hr, 1.5 hrs, 2 hrs, 4 hrs, 8 hrs, 12 hrs & 24 hrs Post-dose. Geometric mean (Geometric Coefficient of Variation). Unit: mg·h/L

Measure	Lefamulin Oral Treatment n = 13	Lefamulin IV Treatment n = 13
Lefamulin	7.277 (0.384)	6.568 (0.286)
Metabolite BC-8041	2.095 (0.448)	0.272 (0.517)

Population analysed: 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.

Adverse events

Time frame: Up-to Follow-up (4 to 7 days after the final dose).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Lefamulin Oral Treatment	0 of 13 (0%)	4 of 13 (30.8%)	0 of 13
Lefamulin IV Treatment	0 of 13 (0%)	4 of 13 (30.8%)	0 of 13
Total	0 of 13 (0%)	6 of 13 (46.2%)	0 of 13

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 38195348Sawicki 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

6 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Lefamulin in people with Cystic Fibrosis, run by Nabriva Therapeutics AG at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Median for Lefamulin and Its Main Metabolite BC-8041 for PK Plasma Parameter Tmax in Cystic Fibrosis (CF) Patients. (time frame: Pre-dose, 0.5 hr, 1 hr, 1.5 hrs, 2 hrs, 4 hrs, 8 hrs, 12 hrs & 24 hrs Post-dose). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05225805, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2024.