NCT02557789

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

A Study to Assess the Bioavailability and Pharmacokinetics of an Immediate Release Tablet Formulation of Lefamulin When Administered to Fed and Fasted Healthy Subjects in Comparison to an Intravenous Formulation and a Capsule Formulation

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Nabriva Therapeutics AG · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed description

This is a single center, single cohort, open label, randomized, four- period cross-over study with healthy subjects receiving a single dose of lefamulin at four study sessions at least 4 days apart. Lefamulin will be taken: 1) as 600 mg IR tablet orally in the fasted state; 2) as 600 mg API in capsule (3 x 200 mg capsules) orally in the fasted state; 3) as 150 mg i.v. infusion in 250 mL citrate buffered saline over 1 h; 4) as 600 mg IR tablet orally one hour after breakfast. The order will be randomized. A total of 20 healthy subjects will be enrolled in the study. The same subjects will take part in all study sessions. After each study session, the Safety Monitoring Team will review the safety and tolerance data before the commencement of the subsequent session.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Lefamulin	Lefamulin administered iv or orally in the fasted state and orally in the fed state

Timeline

• Start date: 2015-06-01
• Primary completion: 2015-06-01
• Completion: 2015-06-01
• First posted: 2015-09-23
• Last updated: 2015-09-23

Locations

1 site across 1 country: United Kingdom