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

Phase 1 Withdrawn Novartis Pharmaceuticals Pharmaceutical Research Associates · collab

Non-randomizedParallel-groupOpen-labelDiagnostic

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

Timeline

Start: 2025-03-19
Primary completion: 2025-07-15
Completion: 2025-07-15

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	BATOPROTAFIB	Small molecule	—	Oral

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

Summary

Timeline

Drugs

Indications