Pharmacokinetics Study of TNO155 in Participants With Mild, Moderate, or Severe Renal Impairment Compared to Matched Healthy Participants - Trial NCT05541159
Access comprehensive clinical trial information for NCT05541159 through Pure Global AI's free database. This Phase 1 trial is sponsored by Novartis Pharmaceuticals and is currently Not yet recruiting. The study focuses on Renal Impairment. Target enrollment is 48 participants.
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Study Focus
Sponsor & Location
Novartis Pharmaceuticals
Novartis
Timeline & Enrollment
Phase 1
Mar 20, 2023
Jul 14, 2023
Primary Outcome
Area under the concentration-versus-time curve (AUC) from time zero to the last measurable plasma concentration (AUClast) of TNO155,AUC from time zero to time t (AUC0-t) of TNO155,AUC from time zero to infinity (AUCinf) of TNO155,Maximum (peak) observed plasma concentration (Cmax) of TNO155,Time to reach maximum observed plasma concentration (Tmax) of TNO155,Elimination half-life (T1/2) of TNO155,Sampling time of the last measurable plasma concentration (Tlast) of TNO155,Apparent plasma clearance (CL/F) of TNO155,Apparent volume of distribution during terminal phase (Vz/F) of TNO155
Summary
The purpose of this Phase 1 study is to evaluate the effect of various degrees of renal
 impairment on plasma pharmacokinetics (PK), safety and tolerability of TNO155. The results of
 this study will guide the Novartis recommendation regarding whether or not a dose adjustment
 may be needed when treating patients with renal impairment
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT05541159
Non-Device Trial