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

NCT03131141 | Completed Phase 1 FDA Drug

• 1 other identifier: NAB-BC-3781-1013
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (6)

• Amount of radioactivity eliminated in urine

  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

  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

  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

  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

  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

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

  Day 1 pre-dose to Day 8 post-dose

Secondary Outcomes (15)

• Safety - hematology

  Day 1 pre-dose to Day 8 post-dose

• Safety - clinical chemistry

  Day 1 pre-dose to Day 8 post-dose

• Safety - urinalysis

  Day 1 pre-dose to Day 8 post-dose

• Safety - electrocardiograms

  Day 1 pre-dose to Day 8 post-dose

• Safety - vital signs

  Day 1 pre-dose to Day 8 post-dose

Study Arms (2)

Cohort A

EXPERIMENTAL

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

Cohort B

EXPERIMENTAL

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

Interventions

BC-3781 DRUG

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

Also known as: Lefamulin

Cohort A; Cohort B

Eligibility Criteria

• Age: 30 Years - 65 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nabriva Therapeutics AG: lead
• Quotient Clinical: collaborator

Study Sites (1)

Quotient Clinical

Nottingham, NG11 6JS, United Kingdom

Location

MeSH Terms

Interventions

lefamulin

Study Officials

• Elyse Seltzer, MD

  Nabriva Therapeutics AG

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: open label
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2017
• First Posted: April 27, 2017
• Study Start: January 8, 2017
• Primary Completion: October 9, 2017
• Study Completion: March 30, 2018
• Last Updated: April 3, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)