A Phase 1 Clinical Study in Healthy Volunteers to Investigate the Drug-drug Interaction Between Multiple Doses of RO7033877 and Multiple Doses of Colistin Methanesulfonate Sodium (CMS)

Lead sponsor

Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.

Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.

Study arms

• Experimental
  Treatment Sequence 1

  Participants will be randomized to one of two treatment sequences. Sequence 1 is: Period 1, RO7033877; Period 2, CMS; Period 3, RO7033877 + CMS. Each period is separated by a wash-out period of at least 6 days between last dose and start of next treatment.

  Drug: CMS · Drug: RO7033877 · Drug: RO7033877 + CMS

• Experimental
  Treatment Sequence 2

  Participants will be randomized to one of two treatment sequences. Sequence 2 is: Period 1, CMS; Period 2, RO7033877; Period 3, RO7033877 + CMS. Each period is separated by a wash-out period of at least 6 days between last dose and start of next treatment.

  Drug: CMS · Drug: RO7033877 · Drug: RO7033877 + CMS

Interventions

• DrugCMS

  Multiple doses of CMS over 2.5 days

• DrugRO7033877

  Multiple doses of RO7033877 over 2.5 days

• DrugRO7033877 + CMS

  Multiple doses of RO7033877 and CMS over 2.5 days

Primary outcomes

1. Multiple dose pharmacokinetics of RO7033877 and colistin/CMS (as appropriate): Cmax and area under the concentration-time curve (AUC)

   Time frame: up to 4 days (for each period)

Secondary outcomes

1. Incidence of adverse events (AEs)

   Time frame: Up to 9 weeks