NCT02557789

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Jun 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 27, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 23, 2015

Completed
Last Updated

September 23, 2015

Status Verified

September 1, 2015

Enrollment Period

Same day

First QC Date

July 27, 2015

Last Update Submit

September 22, 2015

Conditions

Healthy

Keywords

Absolute bioavailabilityPharmacokinetics

Outcome Measures

Primary Outcomes (1)

  • The area under the concentration time curve (AUC) of an intravenous and oral formulation of lefamulin in the fasting state

    36 hours

Secondary Outcomes (3)

  • The area under the concentration time curve (AUC) of a tablet and capsule formulation of lefamulin in the fasting state

    36 hours

  • The area under the concentration time curve (AUC) of a 600 mg IR tablet of lefamulin in the fed state

    36 hours

  • Assessment of the safety and tolerability of lefamulin when administered, as single doses orally and i.v. to healthy subjects aged 18 to 55 years (adverse events, laboratory assessments, vital signs and electrocardiograms)

    36 hours

Study Arms (4)

Treatment A

EXPERIMENTAL

Lefamulin as a 600 mg IR tablet in the fasted state

Drug: Lefamulin

Treatment B

EXPERIMENTAL

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

Drug: Lefamulin

Treatment C

EXPERIMENTAL

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

Drug: Lefamulin

Treatment D

EXPERIMENTAL

Lefamulin as a 600 mg IR tablet one hour after breakfast

Drug: Lefamulin

Interventions

LefamulinDRUG

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

Also known as: BC-3781
Treatment ATreatment BTreatment CTreatment D

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Quotient Clinical

Nottingham, NG11 9JS, United Kingdom

Location

MeSH Terms

Interventions

lefamulin

Study Officials

  • William T Prince, MB, BChir

    Nabriva Therapeutics AG

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 27, 2015

First Posted

September 23, 2015

Study Start

June 1, 2015

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

September 23, 2015

Record last verified: 2015-09

Locations

GB(1)