NCT05631938

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

A Phase I, Open-Label Study to Evaluate the Effect of Renal Impairment and Dialysis Treatment on the Pharmacokinetics of a Single 3 mg Cytisinicline Dose.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Achieve Life Sciences · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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.

Conditions

• Renal Impairment

Interventions

Type	Name	Description
DRUG	cytisinicline	film-coated oral tablets containing 3 mg cytisinicline

Timeline

• Start date: 2023-01-10
• Primary completion: 2023-09-04
• Completion: 2023-09-04
• First posted: 2022-11-30
• Last updated: 2025-07-11

Locations

6 sites across 2 countries: Portugal, Spain

Regulatory

• FDA-regulated drug study