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

NCT ID: NCT02557789

Last Updated: 2015-09-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2015-06-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Blinding Strategy: NONE

Study Groups

Treatment A

Lefamulin as a 600 mg IR tablet in the fasted state

Group Type: EXPERIMENTAL

Lefamulin

Intervention Type: DRUG

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

Treatment B

Lefamulin as 600 mg API in capsule (three 200 mg capsules) in the fasted state

Group Type: EXPERIMENTAL

Lefamulin

Intervention Type: DRUG

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

Treatment C

Lefamulin as 150 mg i.v. in 250 mL citrate buffered saline infused over 1 h

Group Type: EXPERIMENTAL

Lefamulin

Intervention Type: DRUG

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

Treatment D

Lefamulin as a 600 mg IR tablet one hour after breakfast

Group Type: EXPERIMENTAL

Lefamulin

Intervention Type: DRUG

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

Interventions

Lefamulin

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

Intervention Type: DRUG

Other Intervention Names

BC-3781

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Nabriva Therapeutics AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

William T Prince, MB, BChir

Role: STUDY_CHAIR

Nabriva Therapeutics AG

Locations

Quotient Clinical

Nottingham, , United Kingdom

Countries

United Kingdom

Other Identifiers

NAB-BC-3781-1107

Identifier Type: -

Identifier Source: org_study_id