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

April 1, 2018 updated by: Nabriva Therapeutics AG

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Nottingham, United Kingdom, NG11 6JS
        • Quotient Clinical

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

30 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Cohort A
Cohort 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
Drug: BC-3781
Lefamulin (BC-3781) is a potent, semi-synthetic antibacterial belonging to a novel class for systemic human use known as the pleuromutilins
Other Names:
  • Lefamulin
Experimental: Cohort B
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
Drug: BC-3781
Lefamulin (BC-3781) is a potent, semi-synthetic antibacterial belonging to a novel class for systemic human use known as the pleuromutilins
Other Names:
  • Lefamulin

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Amount of radioactivity eliminated in urine
Time Frame: Day 1 pre-dose to Day 8 post-dose
Amount excreted (Ae) and AE as a percentage of administered dose (%Ae)
Day 1 pre-dose to Day 8 post-dose
Amount of radioactivity eliminated in feces
Time Frame: Day 1 pre-dose to Day 8 post-dose
Amount excreted (Ae) and AE as a percentage of administered dose (%Ae)
Day 1 pre-dose to Day 8 post-dose
Amount of radioactivity eliminated in urine and feces
Time Frame: Day 1 pre-dose to Day 8 post-dose
Amount excreted (Ae) and AE as a percentage of administered dose (%Ae)
Day 1 pre-dose to Day 8 post-dose
Cumulative amount of radioactivity eliminated in urine
Time Frame: Day 1 pre-dose to Day 8 post-dose
Cumulative recovery (CumAe)and CumAe as a percentage of the dose (Cum%Ae)
Day 1 pre-dose to Day 8 post-dose
Cumulative amount of radioactivity eliminated in feces
Time Frame: Day 1 pre-dose to Day 8 post-dose
Cumulative recovery (CumAe)and CumAe as a percentage of the dose (Cum%Ae)
Day 1 pre-dose to Day 8 post-dose
Cumulative amount of radioactivity eliminated in urine and feces
Time Frame: Day 1 pre-dose to Day 8 post-dose
Cumulative recovery (CumAe)and CumAe as a percentage of the dose (Cum%Ae)
Day 1 pre-dose to Day 8 post-dose

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Safety - hematology
Time Frame: Day 1 pre-dose to Day 8 post-dose
Safety as assessed by review of changes in hematology
Day 1 pre-dose to Day 8 post-dose
Safety - clinical chemistry
Time Frame: Day 1 pre-dose to Day 8 post-dose
Safety as assessed by review of changes in clinical chemistry
Day 1 pre-dose to Day 8 post-dose
Safety - urinalysis
Time Frame: Day 1 pre-dose to Day 8 post-dose
Safety as assessed by review of changes in urinalysis
Day 1 pre-dose to Day 8 post-dose
Safety - electrocardiograms
Time Frame: Day 1 pre-dose to Day 8 post-dose
Safety as assessed by review of changes in electrocardiograms
Day 1 pre-dose to Day 8 post-dose
Safety - vital signs
Time Frame: Day 1 pre-dose to Day 8 post-dose
Safety as assessed by review of changes in vital signs
Day 1 pre-dose to Day 8 post-dose
Safety - adverse events
Time Frame: Day 1 pre-dose to Day 8 post-dose
Safety as assessed by review of adverse events
Day 1 pre-dose to Day 8 post-dose
Metabolic profiling and structural identification in plasma
Time Frame: Day 1 pre-dose to Day 8 post-dose
Number of metabolites >10% of circulating radioactivity in plasma
Day 1 pre-dose to Day 8 post-dose
Metabolic profiling and structural identification in urine
Time Frame: Day 1 pre-dose to Day 8 post-dose
Number of metabolites >10% of the dose in urine
Day 1 pre-dose to Day 8 post-dose
Metabolic profiling and structural identification in feces
Time Frame: Day 1 pre-dose to Day 8 post-dose
Number of metabolites >10% of the dose in feces
Day 1 pre-dose to Day 8 post-dose
PK of total radioactivity: lag time (tlag), BC-3781 and major metabolites
Time Frame: Day 1 pre-dose to Day 8 post-dose
Assessment of pharmacokinetics of lefamulin as assessed by radioactivity lag time
Day 1 pre-dose to Day 8 post-dose
PK of total radioactivity: Cmax
Time Frame: Day 1 pre-dose to Day 8 post-dose
Peak plasma concentration (Cmax), BC-3781 and major metabolites
Day 1 pre-dose to Day 8 post-dose
PK of total radioactivity: AUC
Time Frame: Day 1 pre-dose to Day 8 post-dose
area under the plasma concentration-time curve from time zero to time of last measurable concentration (AUC last) of BC-3781 and major metabolites
Day 1 pre-dose to Day 8 post-dose
PK of total radioactivity: AUC (0-infinity)
Time Frame: Day 1 pre-dose to Day 8 post-dose
area under the plasma concentration-time curve from time zero to infinity (AUCinf), BC-3781 and major metabolites
Day 1 pre-dose to Day 8 post-dose
PK of total radioactivity: Time to Cmax
Time Frame: Day 1 pre-dose to Day 8 post-dose
Time to reach total maximum observed concentration (tmax), BC-3781 and major metabolites
Day 1 pre-dose to Day 8 post-dose
PK of total radioactivity: elimination half-life
Time Frame: Day 1 pre-dose to Day 8 post-dose
elimination half-life (t1/2), BC-3781 and major metabolites
Day 1 pre-dose to Day 8 post-dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nabriva Therapeutics AG

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Quotient Clinical

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Elyse Seltzer, MD, Nabriva Therapeutics AG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 8, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 9, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 30, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 16, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 24, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 27, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 3, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 1, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NAB-BC-3781-1013

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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