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

NCT03131141 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2018-04-03

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Quotient Clinical

    collaborator OTHER

  • Nabriva Therapeutics AG

    lead INDUSTRY

Principal Investigators

  • Elyse Seltzer, MD · Nabriva Therapeutics AG

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-01-08
Primary Completion
2017-10-09
Completion
2018-03-30
FDA Drug
Yes

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03131141 on ClinicalTrials.gov