Smoking Cessation
Conditions
Brief summary
The primary objective of this trial is to assess the effects of cytisinicline at therapeutic and supratherapeutic doses on cardiac repolarization relative to placebo in healthy adult subjects who are smokers.
Interventions
DRUGCytisinicline
compressed film-coated tablet containing 3 mg cytisinicline
DRUGPlacebo
Placebo tablets to match compressed film-coated tablet containing 3 mg cytisinicline
DRUGMoxifloxacin
400 mg tablets
Sponsors
Achieve Life Sciences
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Only the moxifloxacin treatment will not be blinded to site personnel and the participants, but moxifloxacin treatment will be blinded to the central cardiologist for assessments.
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
Subjects must meet ALL of the following criteria to be eligible for inclusion into the study: 1. Regular moderate cigarette smokers (minimum 10 cigarettes per day). 2. Healthy males and females 18-45 years of age. 3. If woman, she meets one of the following criteria: 1. is of non-childbearing potential (refer to Section 8.3-Contraception Requirements for the criteria for non-childbearing potential status); or 2. is of childbearing potential and agrees to use an accepted contraceptive method (refer to Section 8.3-Contraception Requirements for a list of accepted methods) from at least 4 weeks prior to admission to period 1 until at least the last study drug administration. 4. No clinically significant abnormal serum chemistry or hematology values at Screening. 5. Body mass index (BMI) within 18-30 kg/m2 at Screening. 6. Subject must be willing to communicate with the investigator and site staff and comply with all study procedures and requirements. 7. Subject must be able to provide written, informed consent including compliance with the requirements listed in the consent form. 8. Subject must be able and willing to swallow whole tablets without breaking, cutting, or chewing.
Exclusion criteria
Subjects meeting ANY of the following
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Predicted Placebo-Adjusted Change From Baseline in the Corrected QT Interval using Fridericia's Formula (QTcF) Interval (ΔΔQTcF) | Day -1 (first treatment period only) and on Day 1 (the day of dosing during each treatment period) from approximately 1 hour pre-dose on Day 1 through approximately 24 hours post dose on Day 1. |
Secondary
| Measure | Time frame |
|---|---|
| Placebo-Adjusted Change From Baseline Over Time in Heart Rate (HR) | Day -1 (first treatment period only) and on Day 1 (the day of dosing during each treatment period) from approximately 1 hour pre-dose on Day 1 through approximately 24 hours post dose on Day 1. |
| Placebo-Adjusted Change From Baseline Over Time in PR Interval of the Electrocardiogram (PR) | Day -1 (first treatment period only) and on Day 1 (the day of dosing during each treatment period) from approximately 1 hour pre-dose on Day 1 through approximately 24 hours post dose on Day 1. |
| Placebo-Adjusted Change From Baseline Over Time in QRS Interval of the Electrocardiogram (QRS) Duration | Day -1 (first treatment period only) and on Day 1 (the day of dosing during each treatment period) from approximately 1 hour pre-dose on Day 1 through approximately 24 hours post dose on Day 1. |
| Predicted Placebo-Adjusted Change From Baseline in HR (ΔΔHR) | Day -1 (first treatment period only) and on Day 1 (the day of dosing during each treatment period) from approximately 1 hour pre-dose on Day 1 through approximately 24 hours post dose on Day 1. |
| Predicted Placebo-Adjusted Change From Baseline in PR (ΔΔPR) | Day -1 (first treatment period only) and on Day 1 (the day of dosing during each treatment period) from approximately 1 hour pre-dose on Day 1 through approximately 24 hours post dose on Day 1. |
| Predicted Placebo-Adjusted Change From Baseline in QRS Duration (ΔΔQRS) | Day -1 (first treatment period only) and on Day 1 (the day of dosing during each treatment period) from approximately 1 hour pre-dose on Day 1 through approximately 24 hours post dose on Day 1. |
| Placebo-Adjusted Change From Baseline Over Time in Corrected QT Interval (QTc; Corrected for Heart Rate Based on the ΔΔQTcF) | Day -1 (first treatment period only) and on Day 1 (the day of dosing during each treatment period) from approximately 1 hour pre-dose on Day 1 through approximately 24 hours post dose on Day 1. |
| Uncorrected Change From Baseline Over Time in QT Interval of the Electrocardiogram (QT) | Day -1 (first treatment period only) and on Day 1 (the day of dosing during each treatment period) from approximately 1 hour pre-dose on Day 1 through approximately 24 hours post dose on Day 1. |
| Uncorrected Change From Baseline Over Time in PR | Day -1 (first treatment period only) and on Day 1 (the day of dosing during each treatment period) from approximately 1 hour pre-dose on Day 1 through approximately 24 hours post dose on Day 1. |
| Uncorrected Change From Baseline Over Time in QRS | Day -1 (first treatment period only) and on Day 1 (the day of dosing during each treatment period) from approximately 1 hour pre-dose on Day 1 through approximately 24 hours post dose on Day 1. |
| Uncorrected Change From Baseline Over Time in HR | Day -1 (first treatment period only) and on Day 1 (the day of dosing during each treatment period) from approximately 1 hour pre-dose on Day 1 through approximately 24 hours post dose on Day 1. |
| Percentage of Participants Meeting Outlier Criteria Based on Uncorrected QT, PR, QRS, and HR Values | Day -1 (first treatment period only) and on Day 1 (the day of dosing during each treatment period) from approximately 1 hour pre-dose on Day 1 through approximately 24 hours post dose on Day 1. |
| Percentage of Participants With New Onset (Post-Baseline) Findings on ECG Morphology | Day -1 (first treatment period only) and on Day 1 (the day of dosing during each treatment period) from approximately 1 hour pre-dose on Day 1 through approximately 24 hours post dose on Day 1. |
Countries
Portugal
Outcome results
None listed