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

• Status: Completed
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Nabriva Therapeutics AG
• Treatments: Lefamulin

Criteria

Inclusion Criteria:

• Healthy subjects 18-55 years of age

• Good state of health (mentally and physically) as determined by the investigator

• Body mass index within the range 19 to 32 kg/m2 inclusive

• A signed and dated written informed consent form

• The subject is able to understand and willing to comply with protocol requirements and timetables, instructions and protocol-stated restrictions

Exclusion Criteria:

• Any acute or chronic illness or clinically relevant abnormality identified on the screening medical assessment, laboratory tests or ECG (12-lead or Holter), unless in the opinion of the investigator, in consultation with the Nabriva medical monitor, it will not interfere with the study procedures, affect the outcome of the study or compromise the safety of the subject

• A known history of chronic liver or biliary disease, history of Gilbert's syndrome or an elevated bilirubin level

• History of gastritis, gastrointestinal tract disorders or other clinical condition or previous surgery that might affect the absorption, distribution, biotransformation, or excretion of lefamulin

• Use of prescription or non-prescription drugs within 7 days or 10 times the elimination half-life (whichever is longer) prior to first dose of study medication

• Any intake of prescription or non-prescription drugs known to induce or inhibit drug-metabolizing enzymes or transport system enzymes within a period of less than 10 times the respective elimination half-life, or intake of grapefruit juice or grapefruit containing products within 7 days prior to first dose of study drug.