The purpose of the study is to evaluate the pharmacokinetics (PK) of suzetrigine (SUZ) and its active metabolite in breast milk of lactating female participants. In addition, the purpose is also to evaluate the relative infant dose (RID), safety and tolerability of SUZ and its active metabolite in lactating female participants.
Phase 1 trials primarily test safety and dosing in a small number of participants (typically 20–100). Results do not yet speak to efficacy. FDA approval is typically many years away from this stage.
This trial has completed. Results may be available via ClinicalTrials.gov or peer-reviewed publications.
Vertex Pharmaceuticals (VRTX) is the sponsoring company for this trial. BiotechSign currently grades this company C (61/100) based on composite catalyst signals across its full pipeline. This trial is one data point in that overall catalyst picture.