NCT05981768

Study to Evaluate Effect of Food on Bioavailability of Single 3 mg Tablet and Pharmacokinetics (PK) of Multiple 3 mg Doses in Healthy Adult Smokers

A Phase 1 Study to Investigate the Effect of Food on the Bioavailability of a Single Cytisinicline 3 mg Tablet and Evaluation of the Pharmacokinetics of Multiple 3 mg Doses (Three Times Daily) in Healthy Adult Smokers
Achieve Life Sciences·Phase 1·ClinicalTrials.gov·drugNot yet recruiting
View on ClinicalTrials.gov
Study focus
Disease/Condition
Smoking Cessation
Drug/Device/Intervention
Cytisinicline
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Achieve Life Sciences
Location
Porto, Portugal
Timeline & enrollment
Phase
Phase 1
Start date
Aug 01, 2023
End date
Nov 01, 2023
Enrollment
30 participants
Primary outcome

Maximum Observed Plasma Concentration (Cmax),Time of Maximum Observed Plasma Concentration (Tmax),Time Point Prior to the First Quantifiable Concentration (Tlag),Time of Last Quantifiable Observed Concentration (Tlast),Area Under Plasma Concentration-Time Curve (AUC) Over the Dosing Interval (AUC0-τ),AUC From Time of Dosing (t=0h) to the Time of the Last Quantifiable Concentration (AUC0-t),Total AUC Extrapolated to Infinity (AUC0-∞),Percentage of AUC0-∞ Due to Extrapolation From the Time of the Last Quantifiable Concentration (Tlast) to Infinity (%AUCextrap),Apparent Terminal Elimination Rate Constant (λz),Apparent Terminal Elimination Half-Life (t1/2),Apparent Clearance (CL/F),Apparent Volume of Distribution (V/F),Pre-dose Plasma Concentration (Ctrough) for Dose 1, Dose 2 and Dose 3,Cmax for Dose 1, Dose 2 and Dose 3,Tmax for Dose 1, Dose 2 and Dose 3,AUC0-τ for Dose 1, Dose 2 and Dose 3,Concentration Over the Dosing Interval (Cτ) for Dose 1, Dose 2 and Dose 3,Apparent Terminal Elimination Half-Life Interval (t1/2) post Dose 3,Ratio of Cmax (R[Cmax]),Ratio of AUC0-τ (R[AUC0-τ]),R(AUC0-τ/AUC0-∞),Time to Steady State,Number of Participants With Treatment Emergent Adverse Events (AEs),Number of Participants With Clinically Significant Changes From Baseline in Electrocardiograms (ECG),Number of Participants With Clinically Significant Changes From Baseline in Vital Signs,Number of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Tests

Summary

To assess the effect of food on the bioavailability of 3 mg cytisinicline following
 single-dose administration, and to evaluate the PK profile of 3 mg cytisinicline TID
 following multiple days of administration during Days 5-8.

ICD-10 classifications
Mental and behavioural disorders due to use of tobacco withdrawal stateTobacco useExposure to tobacco smokeToxic effect: Tobacco and nicotineMental and behavioural disorders due to use of tobacco
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT05981768
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT05981768 through Pure Global AI's free database. This Phase 1 trial is sponsored by Achieve Life Sciences and is currently Not yet recruiting. The study focuses on Smoking Cessation. Target enrollment is 30 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.