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 - Trial NCT05981768

Timeline & Enrollment

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