CompletedPhase 1

A Study to Investigate the Pharmacokinetics and Safety of Remibrutinib in Participants With Severe Renal Impairment Compared to Matched Healthy Participants.

United States16 participantsStarted 2025-07-23

Plain-language summary

The purpose of this study is to support the development of remibrutinib dosing recommendations for patients with impaired renal function.

Age range18 Years – 75 Years

SexALL

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Cmax, ss of remibrutinib in blood

Timeframe: Up to 72 hours postdose

AUCtau,ss of remibrutinib in blood

Timeframe: Up to 72 hours postdose

Ae0-12h,ss of remibrutinib in urine

Timeframe: Up to 12 hours postdose

CLr,ss of remibrutinib in urine

Timeframe: Up to 12 hours postdose

NCT IDNCT07032272

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-10-12