PK of CHF6001 in Subjects With Mild, Moderate and Severe Renal Impairment vs. Healthy Volunteers

Phase 1 Completed 44 enrolled Chiesi Farmaceutici S.p.A.

Non-randomizedParallel-groupOpen-labelOther

Summary

The purpose of the study is to obtain pharmacokinetics, safety and tolerability data after single administrations of CHF6001 in subjects with mild, moderate and severe renal impairment as well as healthy volunteers under the same setting.

Timeline

Start: 2022-07-29
Primary completion: 2022-12-27
Completion: 2022-12-27

Publications

Piccinno A, Pittelli MG, Balzano D, Rizzo E, Bellatti P, Rostello C, Emirova A. Evaluating the Impact of Hepatic or Renal Impairment on Tanimilast (CHF6001) Pharmacokinetics: Two Open-Label, Parallel-Group, Single-Center Studies. Clin Transl Sci. 2025 May;18(5):e70261. doi: 10.1111/cts.70261.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	TRANIMILAST	Small molecule	800 ug	Inhaled

PK of CHF6001 in Subjects With Mild, Moderate and Severe Renal Impairment vs. Healthy Volunteers

Summary

Timeline

Publications

Drugs

Indications