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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.
Achieve Life Sciences·Phase 1·ClinicalTrials.gov·drugRecruiting
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Study focus
Disease/Condition
Renal Impairment
Drug/Device/Intervention
cytisinicline
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Achieve Life Sciences
Location
Gaia,Matosinhos,Braga,Porto,Madrid,Madrid,Madrid, Portugal,Spain
Timeline & enrollment
Phase
Phase 1
Start date
Jan 10, 2023
End date
Jun 01, 2023
Enrollment
56 participants
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-∞),Plasma PK Parameter: Apparent Terminal Elimination Rate Constant (λz),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
Renal failureDisorders resulting from impaired renal tubular functionDisorder resulting from impaired renal tubular function, unspecifiedOther disorders resulting from impaired renal tubular functionAcute renal failure
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT05631938
Type
Non-Device Trial
About this record

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.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.