Study to Evaluate the Effect of Renal Impairment and Dialysis Treatment on the Pharmacokinetics of a Single 3 mg Cytisinicline Dose - Trial NCT05631938
Access comprehensive clinical trial information for NCT05631938 through Pure Global AI's free database. This Phase 1 trial is sponsored by Achieve Life Sciences and is currently Recruiting. The study focuses on Renal Impairment. Target enrollment is 56 participants.
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Study Focus
Sponsor & Location
Achieve Life Sciences
Timeline & Enrollment
Phase 1
Jan 10, 2023
Jun 01, 2023
Primary Outcome
Plasma Pharmacokinetic (PK) Parameter: Maximum Observed Plasma Concentration (Cmax),Plasma PK Parameter: Time of Occurrence of Cmax (Tmax),Plasma PK Parameter: Area Under the Plasma Concentration Versus Time Curve (AUC) From Time of Dosing (t=0h) to the Time of the Last Measurable Concentration (AUC0-t),Plasma PK Parameter: Total AUC Extrapolated to Infinity (AUC0-โ),Plasma PK Parameter: Apparent Terminal Elimination Rate Constant (ฮปz),Plasma PK Parameter: Apparent Terminal Elimination Half-Life (t1/2),Plasma PK Parameter: Fraction Unbound (fu),Plasma PK Parameter: Apparent Clearance (CL/F),Plasma PK Parameter: Apparent Volume of Distribution (V/F),Urine PK Parameter: Amount of Drug Excreted in Urine (Ae),Urine PK Parameter: Fraction of Unchanged Drug Excreted in Urine (fe),Urine PK Parameter: Area Under the Urine Excretion Rate Curve From Time Zero to Last Measurable Observed Excretion Rate (AURC),Urine PK Parameter: Renal Clearance (CLR),Urine PK Parameter: Apparent Nonrenal Clearance (CLNR/F),PK Parameter in Dialysate, Group 5 (ESRD on-dialysis): Amount of Drug Recovered From Each Dialysate Collection (AD),PK Parameter in Dialysate, Group 5 (ESRD on-dialysis): Cumulative Amount of Drug Recovered From the Dialysate (AD, total),PK Parameter in Dialysate, Group 5 (ESRD on-dialysis): Partial Area Under the Curve Estimated From Predialyzer Samples Collected From Start of Dialysis (t0) to End of Dialysis (t1) (AUCt0-t1),PK Parameter in Dialysate, Group 5 (ESRD on-dialysis): Dialysis Clearance (CLD),PK Parameter in Dialysate, Group 5 (ESRD on-dialysis): Fraction of the Administered Dose That is Recovered in the Dialysate (Frem)
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.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT05631938
Non-Device Trial