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HealthyPhase 1NCT03131141

A Study to Assess Mass Balance Recovery, Metabolite Profile and Identification of IV and Oral 14C-BC-3781

A Phase 1 study testing BC-3781 in people with Healthy, run by Nabriva Therapeutics AG at 1 site in United Kingdom.

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 is a single-centre, open-label, non-randomized, single dose study in healthy male subjects designed to assess mass balance recovery, metabolite profile and metabolite identification of radio-labeled BC-3781 administered via the intravenous or oral routes. Read more about this study

Who is it for?
Ages 30 to 65 years, men onlyHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
BC-3781
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteUnited Kingdom
Study dates
8 Jan 2017to 30 Mar 2018
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 30 to 65 years
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Healthy males
  • Aged 30 to 65 years
  • Body mass index of 18.0 to 35.0 kg/m2, inclusive
  • Must have regular bowel movements
  • Must provide written informed consent
  • Must agree to use an adequate method of contraception

Who cannot join

  • Subjects who have received any IMP in a clinical research study within the previous 3 months
  • History of any drug or alcohol abuse in the past 2 years
  • Regular alcohol consumption in males >21 units per week and females >14 units per week
  • Radiation exposure, including that from the present study, excluding background radiation but including diagnostic x-rays and other medical exposures, exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 1999, shall participate in the study
  • Subjects who do not have suitable veins for multiple venepunctures/cannulation as assessed by the investigator at screening
  • Subjects who have been dosed in an ADME study in the last 12 months
Show all 19Show fewer
  • Clinically significant abnormal biochemistry, haematology or urinalysis as judged by the investigator
  • Positive drugs of abuse test result at screening and admission
  • Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results
  • Evidence of renal impairment at screening, as indicated by an estimated creatinine clearance (CLcr) of <90 mL/min using the Cockcroft-Gault equation
  • Significant history of cardiovascular, renal, hepatic, chronic respiratory or gastrointestinal disease, or psychiatric disorders as judged by the investigator
  • A familial history or presence of Long QT syndrome
  • Subjects with QT interval corrected according to Fridericia's formula (QTcF) >480 ms
  • A serum potassium level of less than 3.5 mmol/L at screening
  • Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients
  • Presence or history of clinically significant allergy requiring treatment, as judged by the investigator.
  • Donation or loss of greater than 400 mL of blood within the previous 3 months
  • Have taken medications known to be strong P-gp inhibitors, or strong CYP3A4 inducers or inhibitors, within 28 days before IMP administration
  • Subjects who are taking, or have taken, any prescribed or over-the-counter drug (other than 4 g per day paracetamol or herbal remedies) in the 14 days before IMP administration

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • Quotient Clinical

    Nottingham, NG11 6JS

Other trials in United Kingdom

About this study

Official title: An Open Label, Single-dose, Single-period Study Designed to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of 14C-BC-3781 Administered Via the Intravenous or Oral Routes to Healthy Male Subjects

This is a single-centre, open-label, non-randomized, single dose study in healthy male subjects designed to assess mass balance recovery, metabolite profile and metabolite identification of radio-labeled BC-3781 administered via the intravenous or oral routes.

Read the detailed description

This is a single-centre, open-label, non-randomised, single dose study to assess the pharmacokinetics, mass balance recovery, and metabolite profiling and identification following administration of iv or oral 14C-BC-3781 to healthy male subjects It is planned to enrol 2 cohorts of 5 subjects or 10 subjects in total. The active substance being investigated in this study is radiolabeled lefamulin ([14C] BC 3781), present in the investigational medicinal products (IMPs) as the acetate salt ([14C]-BC-3781.Ac).

Subjects assigned to Cohort A will receive a single IV administration of 14C-BC-3781 containing 150 mg BC-3781 and not more than (NMT) 4.3 MBq (117 µCi) 14C, administered as an infusion over 60 min after a light breakfast.

Subjects assigned to Cohort B will receive a single oral administration of 14C-BC-3781 containing 600 mg BC-3781 and NMT 4.1 MBq (112 µCi) 14C, in the fasted state

Conditions
Healthy
Being tested
BC-3781

What participants receive

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

  • BC-3781Drug

    Also called Lefamulin

    Lefamulin (BC-3781) is a potent, semi-synthetic antibacterial belonging to a novel class for systemic human use known as the pleuromutilins

Study groups in NCT03131141
Study groupRoleWhat they receive
Cohort AExperimentalCohort A will receive a single IV administration of 14C-BC-3781 containing 150 mg BC-3781 and NMT 4.3 MBq (117 µCi) 14C, administered as an infusion over 60 min after a light breakfast
Receives: Drug: BC-3781
Cohort BExperimentalCohort B will receive a single oral administration of 14C-BC-3781 containing 600 mg BC-3781 and NMT 4.1 MBq (112 µCi) 14C, in the fasted state
Receives: Drug: BC-3781

What is being measured

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

  1. Amount of radioactivity eliminated in urine

    Amount excreted (Ae) and AE as a percentage of administered dose (%Ae)

    Measured: Day 1 pre-dose to Day 8 post-dose

  2. Amount of radioactivity eliminated in feces

    Amount excreted (Ae) and AE as a percentage of administered dose (%Ae)

    Measured: Day 1 pre-dose to Day 8 post-dose

  3. Amount of radioactivity eliminated in urine and feces

    Amount excreted (Ae) and AE as a percentage of administered dose (%Ae)

    Measured: Day 1 pre-dose to Day 8 post-dose

  4. Cumulative amount of radioactivity eliminated in urine

    Cumulative recovery (CumAe)and CumAe as a percentage of the dose (Cum%Ae)

    Measured: Day 1 pre-dose to Day 8 post-dose

  5. Cumulative amount of radioactivity eliminated in feces

    Cumulative recovery (CumAe)and CumAe as a percentage of the dose (Cum%Ae)

    Measured: Day 1 pre-dose to Day 8 post-dose

  6. Cumulative amount of radioactivity eliminated in urine and feces

    Cumulative recovery (CumAe)and CumAe as a percentage of the dose (Cum%Ae)

    Measured: Day 1 pre-dose to Day 8 post-dose

Secondary outcomes (15)

  1. Safety - hematology

    Safety as assessed by review of changes in hematology

    Measured: Day 1 pre-dose to Day 8 post-dose

  2. Safety - clinical chemistry

    Safety as assessed by review of changes in clinical chemistry

    Measured: Day 1 pre-dose to Day 8 post-dose

  3. Safety - urinalysis

    Safety as assessed by review of changes in urinalysis

    Measured: Day 1 pre-dose to Day 8 post-dose

  4. Safety - electrocardiograms

    Safety as assessed by review of changes in electrocardiograms

    Measured: Day 1 pre-dose to Day 8 post-dose

  5. Safety - vital signs

    Safety as assessed by review of changes in vital signs

    Measured: Day 1 pre-dose to Day 8 post-dose

  6. Safety - adverse events

    Safety as assessed by review of adverse events

    Measured: Day 1 pre-dose to Day 8 post-dose

  7. Metabolic profiling and structural identification in plasma

    Number of metabolites >10% of circulating radioactivity in plasma

    Measured: Day 1 pre-dose to Day 8 post-dose

  8. Metabolic profiling and structural identification in urine

    Number of metabolites >10% of the dose in urine

    Measured: Day 1 pre-dose to Day 8 post-dose

  9. Metabolic profiling and structural identification in feces

    Number of metabolites >10% of the dose in feces

    Measured: Day 1 pre-dose to Day 8 post-dose

  10. PK of total radioactivity: lag time (tlag), BC-3781 and major metabolites

    Assessment of pharmacokinetics of lefamulin as assessed by radioactivity lag time

    Measured: Day 1 pre-dose to Day 8 post-dose

  11. PK of total radioactivity: Cmax

    Peak plasma concentration (Cmax), BC-3781 and major metabolites

    Measured: Day 1 pre-dose to Day 8 post-dose

  12. PK of total radioactivity: AUC

    area under the plasma concentration-time curve from time zero to time of last measurable concentration (AUC last) of BC-3781 and major metabolites

    Measured: Day 1 pre-dose to Day 8 post-dose

  13. PK of total radioactivity: AUC (0-infinity)

    area under the plasma concentration-time curve from time zero to infinity (AUCinf), BC-3781 and major metabolites

    Measured: Day 1 pre-dose to Day 8 post-dose

  14. PK of total radioactivity: Time to Cmax

    Time to reach total maximum observed concentration (tmax), BC-3781 and major metabolites

    Measured: Day 1 pre-dose to Day 8 post-dose

  15. PK of total radioactivity: elimination half-life

    elimination half-life (t1/2), BC-3781 and major metabolites

    Measured: Day 1 pre-dose to Day 8 post-dose

Timeline

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

  1. First posted27 Apr 2017
  2. Study start8 Jan 2017
  3. Primary completion9 Oct 2017
  4. Study completion30 Mar 2018

Resources

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
Basic science
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03131141
Sponsor's protocol ID
NAB-BC-3781-1013
Status last verified
Apr 2018
First submitted
16 Feb 2017
Last updated
3 Apr 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BC-3781 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 6 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 3 Apr 2018. 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?

Amount of radioactivity eliminated in urine (time frame: Day 1 pre-dose to Day 8 post-dose). The study lists 6 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 NCT03131141.

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 3 Apr 2018.

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