HealthyPhase 1NCT02557789
Bioavailability and Pharmacokinetics of Lefamulin When Administered to Fed and Fasted Healthy Subjects
A Phase 1 study testing Lefamulin in people with Healthy, run by Nabriva Therapeutics AG at 1 site in United Kingdom.
Trial summary
A Phase 1 study to assess the bioavailability and pharmacokinetics of a 600 mg immediate release tablet formulation of lefamulin when administered to fed and fasted healthy subjects in comparison to an intravenous formulation and a capsule formulation. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- 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
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2015to Jun 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subjects 18-55 years of age
- Good state of health (mentally and physically) as determined by the investigator
- Body mass index within the range 19 to 32 kg/m2 inclusive
- A signed and dated written informed consent form
- The subject is able to understand and willing to comply with protocol requirements and timetables, instructions and protocol-stated restrictions
Who cannot join
- Any acute or chronic illness or clinically relevant abnormality identified on the screening medical assessment, laboratory tests or ECG (12-lead or Holter), unless in the opinion of the investigator, in consultation with the Nabriva medical monitor, it will not interfere with the study procedures, affect the outcome of the study or compromise the safety of the subject
- A known history of chronic liver or biliary disease, history of Gilbert's syndrome or an elevated bilirubin level
- History of gastritis, gastrointestinal tract disorders or other clinical condition or previous surgery that might affect the absorption, distribution, biotransformation, or excretion of lefamulin
- Use of prescription or non-prescription drugs within 7 days or 10 times the elimination half-life (whichever is longer) prior to first dose of study medication
- Any intake of prescription or non-prescription drugs known to induce or inhibit drug-metabolizing enzymes or transport system enzymes within a period of less than 10 times the respective elimination half-life, or intake of grapefruit juice or grapefruit containing products within 7 days prior to first dose of study drug.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study to Assess the Bioavailability and Pharmacokinetics of an Immediate Release Tablet Formulation of Lefamulin When Administered to Fed and Fasted Healthy Subjects in Comparison to an Intravenous Formulation and a Capsule Formulation
A Phase 1 study to assess the bioavailability and pharmacokinetics of a 600 mg immediate release tablet formulation of lefamulin when administered to fed and fasted healthy subjects in comparison to an intravenous formulation and a capsule formulation.
Read the detailed description
This is a single center, single cohort, open label, randomized, four- period cross-over study with healthy subjects receiving a single dose of lefamulin at four study sessions at least 4 days apart. Lefamulin will be taken: 1) as 600 mg IR tablet orally in the fasted state; 2) as 600 mg API in capsule (3 x 200 mg capsules) orally in the fasted state; 3) as 150 mg i.v. infusion in 250 mL citrate buffered saline over 1 h; 4) as 600 mg IR tablet orally one hour after breakfast.
The order will be randomized. A total of 20 healthy subjects will be enrolled in the study. The same subjects will take part in all study sessions.
After each study session, the Safety Monitoring Team will review the safety and tolerance data before the commencement of the subsequent session.
- Conditions
- Healthy
- Being tested
- Lefamulin
- Keywords
- Absolute bioavailability, Pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LefamulinDrug
Also called BC-3781
Lefamulin administered iv or orally in the fasted state and orally in the fed state
| Study group | Role | What they receive |
|---|---|---|
| Treatment A | Experimental | Lefamulin as a 600 mg IR tablet in the fasted state Receives: Drug: Lefamulin |
| Treatment B | Experimental | Lefamulin as 600 mg API in capsule (three 200 mg capsules) in the fasted state Receives: Drug: Lefamulin |
| Treatment C | Experimental | Lefamulin as 150 mg i.v. in 250 mL citrate buffered saline infused over 1 h Receives: Drug: Lefamulin |
| Treatment D | Experimental | Lefamulin as a 600 mg IR tablet one hour after breakfast Receives: Drug: Lefamulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The area under the concentration time curve (AUC) of an intravenous and oral formulation of lefamulin in the fasting state
Measured: 36 hours
Secondary outcomes (3)
The area under the concentration time curve (AUC) of a tablet and capsule formulation of lefamulin in the fasting state
Measured: 36 hours
The area under the concentration time curve (AUC) of a 600 mg IR tablet of lefamulin in the fed state
Measured: 36 hours
Assessment of the safety and tolerability of lefamulin when administered, as single doses orally and i.v. to healthy subjects aged 18 to 55 years (adverse events, laboratory assessments, vital signs and electrocardiograms)
Assessment of safety and tolerability by recording adverse events, laboratory assessments, vital signs and electrocardiograms
Measured: 36 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2015 (estimated)
- Study startJun 2015
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nabriva Therapeutics AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- William T Prince, MB, BChir, Study chair, Nabriva Therapeutics AG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02557789
- Sponsor's protocol ID
- NAB-BC-3781-1107
- Status last verified
- Sep 2015
- First submitted
- 27 Jul 2015
- Last updated
- 23 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Assess the Bioavailability and Pharmacokinetics of an Immediate Release Tablet Formulation of Lefamulin When Administered to Fed and Fasted Healthy Subjects in Comparison to an Intravenous Formulation and a Capsule Formulation
- ClinicalTrials.gov ID
- NCT02557789
- Acronym / sponsor ID
- NAB-BC-3781-1107
- Conditions
- Healthy
- Keywords
- Absolute bioavailability, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Nabriva Therapeutics AGIndustry (pharma, biotech, devices)
- Study start
- Jun 2015
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 23 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Phase 1 study to assess the bioavailability and pharmacokinetics of a 600 mg immediate release tablet formulation of lefamulin when administered to fed and fasted healthy subjects in comparison to an intravenous formulation and a capsule formulation.
Detailed description
This is a single center, single cohort, open label, randomized, four- period cross-over study with healthy subjects receiving a single dose of lefamulin at four study sessions at least 4 days apart. Lefamulin will be taken: 1) as 600 mg IR tablet orally in the fasted state; 2) as 600 mg API in capsule (3 x 200 mg capsules) orally in the fasted state; 3) as 150 mg i.v. infusion in 250 mL citrate buffered saline over 1 h; 4) as 600 mg IR tablet orally one hour after breakfast.
The order will be randomized. A total of 20 healthy subjects will be enrolled in the study. The same subjects will take part in all study sessions.
After each study session, the Safety Monitoring Team will review the safety and tolerance data before the commencement of the subsequent session.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Experimental | Drug: LefamulinLefamulin as a 600 mg IR tablet in the fasted state |
| Treatment B | Experimental | Drug: LefamulinLefamulin as 600 mg API in capsule (three 200 mg capsules) in the fasted state |
| Treatment C | Experimental | Drug: LefamulinLefamulin as 150 mg i.v. in 250 mL citrate buffered saline infused over 1 h |
| Treatment D | Experimental | Drug: LefamulinLefamulin as a 600 mg IR tablet one hour after breakfast |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy subjects 18-55 years of age
- Good state of health (mentally and physically) as determined by the investigator
- Body mass index within the range 19 to 32 kg/m2 inclusive
- A signed and dated written informed consent form
- The subject is able to understand and willing to comply with protocol requirements and timetables, instructions and protocol-stated restrictions
Key exclusion criteria (5 listed)
- Any acute or chronic illness or clinically relevant abnormality identified on the screening medical assessment, laboratory tests or ECG (12-lead or Holter), unless in the opinion of the investigator, in consultation with the Nabriva medical monitor, it will not interfere with the study procedures, affect the outcome of the study or compromise the safety of the subject
- A known history of chronic liver or biliary disease, history of Gilbert's syndrome or an elevated bilirubin level
- History of gastritis, gastrointestinal tract disorders or other clinical condition or previous surgery that might affect the absorption, distribution, biotransformation, or excretion of lefamulin
- Use of prescription or non-prescription drugs within 7 days or 10 times the elimination half-life (whichever is longer) prior to first dose of study medication
- Any intake of prescription or non-prescription drugs known to induce or inhibit drug-metabolizing enzymes or transport system enzymes within a period of less than 10 times the respective elimination half-life, or intake of grapefruit juice or grapefruit containing products within 7 days prior to first dose of study drug.
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-3781Lefamulin administered iv or orally in the fasted state and orally in the fed state | Drug | Treatment A, Treatment B, Treatment C, Treatment D |
Primary outcome
The area under the concentration time curve (AUC) of an intravenous and oral formulation of lefamulin in the fasting state
Time frame: 36 hours
3 secondary outcomes
The area under the concentration time curve (AUC) of a tablet and capsule formulation of lefamulin in the fasting state
Time frame: 36 hours
The area under the concentration time curve (AUC) of a 600 mg IR tablet of lefamulin in the fed state
Time frame: 36 hours
Assessment of the safety and tolerability of lefamulin when administered, as single doses orally and i.v. to healthy subjects aged 18 to 55 years (adverse events, laboratory assessments, vital signs and electrocardiograms)
Time frame: 36 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2015.
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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.
William T Prince, MB, BChir study chair
Nabriva Therapeutics AG
1 site 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 Healthy, run by Nabriva Therapeutics AG at 1 site in United Kingdom.
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 5 inclusion and 5 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 23 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 area under the concentration time curve (AUC) of an intravenous and oral formulation of lefamulin in the fasting state (time frame: 36 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Sep 2015.