Nicotine addiction
Conditions
Brief summary
Concentration effect modeling: change from baseline in QTc, corrected for HR based on the Fridericia QT correction method (ΔQTcF) compared with matched timepoint cytisinicline concentration. This is used to calculate a predicted placebo-adjusted change from baseline in the QTcF interval (ΔΔQTcF). In the event of an effect on HR of ≥10 bpm, the individual QT correction method (QTcI) will be utilized as the primary QT correction method.
Detailed description
Time-point change from baseline in QTc, placebo-adjusted and corrected for HR based on the Fridericia QT correction (QTcF) method (ΔΔQTcF). In the event of an effect on HR of ≥10 bpm, the individual QT correction method (QTcI) will be utilized as the primary QT correction method., Time-point change from baseline, placebo-adjusted, for HR, PR interval (PR), and QRS duration (QRS)., Evaluation of the relationship between the plasma concentration of cytisinicline and the placebo-adjusted change from baseline in HR, PR, and QRS, Evaluation of the effects of cytisinicline on ECG morphology (including T wave and U wave)., Central tendency and categorical outlier analyses based on uncorrected QT, PR, QRS, and HR.
Interventions
Sponsors
Achieve Life Sciences Inc.
Eligibility
Sex/Gender
All
Age
18 Years to 64 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Concentration effect modeling: change from baseline in QTc, corrected for HR based on the Fridericia QT correction method (ΔQTcF) compared with matched timepoint cytisinicline concentration. This is used to calculate a predicted placebo-adjusted change from baseline in the QTcF interval (ΔΔQTcF). In the event of an effect on HR of ≥10 bpm, the individual QT correction method (QTcI) will be utilized as the primary QT correction method. | — |
Secondary
| Measure | Time frame |
|---|---|
| Time-point change from baseline in QTc, placebo-adjusted and corrected for HR based on the Fridericia QT correction (QTcF) method (ΔΔQTcF). In the event of an effect on HR of ≥10 bpm, the individual QT correction method (QTcI) will be utilized as the primary QT correction method., Time-point change from baseline, placebo-adjusted, for HR, PR interval (PR), and QRS duration (QRS)., Evaluation of the relationship between the plasma concentration of cytisinicline and the placebo-adjusted change from baseline in HR, PR, and QRS, Evaluation of the effects of cytisinicline on ECG morphology (including T wave and U wave)., Central tendency and categorical outlier analyses based on uncorrected QT, PR, QRS, and HR. | — |
Countries
Portugal
Outcome results
None listed