Bioavailability and PK of lefamulin in healthy subjects (QCL117384)

• Research type

  Research Study

• Full title

  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

• IRAS ID

  178354

• Contact name

  William Prince

• Contact email

  william.prince@nabriva.com

• Sponsor organisation

  Nabriva Therapeutics AG

• Eudract number

  2015-000163-14

• Clinicaltrials.gov Identifier

  NCT02557789

• Duration of Study in the UK

  0 years, 1 months, 27 days

• Research summary

  The Sponsor is developing the study drug, lefamulin, as an antibiotic for human use for the treatment of respiratory (lung), skin and sexually transmitted infections.

  The purpose of the study is to see how a fast acting (immediate release) tablet form of lefamulin, is taken up by the body (absorbed) and broken down (metabolised) when given without food (fasted) and with food (fed). This will be compared to two other forms of the study drug (capsule and intravenous).

  Twenty healthy male and female subjects will be enrolled in the study and will each receive a different dose of lefamulin at 4 separate sessions.

• REC name

  HSC REC A

• REC reference

  15/NI/0073

• Date of REC Opinion

  13 May 2015

• REC opinion

  Further Information Favourable Opinion