A Single Centre, Open-label, 2-period Fixed-sequence, Phase I Clinical Study to Evaluate the Effect of BV100 on the Pharmacokinetics of Polymyxin B in Healthy Volunteers

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorBioVersys SAS

About this trial

This is an open-label, fixed sequence Phase I clinical study to evaluate the effect of multiple doses of BV100 on the PK of polymyxin B in healthy participants (HPs).

Eligibility criteria

Qualifiers

Participants who were able to understand and follow instructions during the study.

Participants who signed informed consent.

Female participants 50 years of age or older, in menopause for 24 consecutive months and not receiving any hormone replacement therapy within 24 months prior to inclusion into the study

Female participants who underwent surgical sterilization

Disqualifiers

Unwilling or unable to give informed consent.

As a result of the medical screening process, the study physician considered the participant unfit for the study.

Male participants with female partners who are lactating or pregnant.

Known or suspected history of hypersensitivity to rifabutin or to drugs of a similar chemical class including rifampicin, rifapentine, rifaximin.

Trial design

Treatments tested in this trial

  • BV100 (300 mg)
  • Polymyxin B (50 mg)

Treatment groups

16 Participants
are divided into 1 treatment group

Sponsors and collaborators