drugset / Trial / NCT05631938

Study to Evaluate the Effect of Renal Impairment and Dialysis Treatment on the Pharmacokinetics of a Single 3 mg Cytisinicline Dose

NCT05631938

Phase 1 Completed 44 enrolled Achieve Life Sciences
Non-randomizedParallel-groupOpen-labelTreatment

Summary

The primary objectives of this study are: 1. To obtain information on the pharmacokinetics of cytisinicline following a single oral dose in subjects with varying degrees of renal impairment relative to matched controls with normal renal function. 2. To investigate the extent of cytisinicline removal by hemodialysis.

Timeline

Start
2023-01-10
Primary completion
2023-09-04
Completion
2023-09-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Cytisinicline Small molecule 3 mg Oral