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NCT05541159

Pharmacokinetics Study of TNO155 in Participants With Mild, Moderate, or Severe Renal Impairment Compared to Matched Healthy Participants

A Phase 1, Open-label, Single-dose, Multi-center, Parallel Group Study to Evaluate the Pharmacokinetics of TNO155 in Participants With Mild, Moderate, or Severe Renal Impairment Compared to Matched Healthy Control Participants
Novartis Pharmaceuticals·Phase 1·ClinicalTrials.gov·drugNot yet recruiting
View on ClinicalTrials.gov →
Study focus
Disease/Condition
Renal Impairment
Drug/Device/Intervention
TNO155
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Novartis Pharmaceuticals
Funder
Novartis
Timeline & enrollment
Phase
Phase 1
Start date
Mar 20, 2023
End date
Jul 14, 2023
Enrollment
48 participants
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
Renal failureDisorders resulting from impaired renal tubular functionDisorder resulting from impaired renal tubular function, unspecifiedOther disorders resulting from impaired renal tubular functionAcute renal failure
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT05541159
Type
Non-Device Trial
About this record

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.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.