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Bioavailability and Pharmacokinetics of Lefamulin When Administered to Fed and Fasted Healthy Subjects

NCT02557789 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2015-09-23

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

DRUG

Lefamulin

Lefamulin administered iv or orally in the fasted state and orally in the fed state

Sponsors & Collaborators

  • Nabriva Therapeutics AG

    lead INDUSTRY

Principal Investigators

  • William T Prince, MB, BChir · Nabriva Therapeutics AG

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2015-06-30
Completion
2015-06-30

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 NCT02557789 on ClinicalTrials.gov