Study to Evaluate Electrocardiographic Effects of Therapeutic & Supratherapeutic Doses of Cytisin… (NCT05566288) | Clinical Trial Compass
CompletedPhase 1
Study to Evaluate Electrocardiographic Effects of Therapeutic & Supratherapeutic Doses of Cytisinicline in Healthy Smokers
Portugal27 participantsStarted 2022-10-17
Plain-language 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.
Who can participate
Age range18 Years – 45 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Regular moderate cigarette smokers (minimum 10 cigarettes per day).
✓. Healthy males and females 18-45 years of age.
✓. If woman, she meets one of the following criteria:
✓. is of non-childbearing potential (refer to Section 8.3-Contraception Requirements for the criteria for non-childbearing potential status); or
✓. 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.
✓. No clinically significant abnormal serum chemistry or hematology values at Screening.
✓. Body mass index (BMI) within 18-30 kg/m2 at Screening.
✓. Subject must be willing to communicate with the investigator and site staff and comply with all study procedures and requirements.
Exclusion criteria
✕. History or presence of a systemic disease, which as judged by the investigator, may affect the subject's ability to participate in the study or in the outcome of the study.
✕. Evidence of infection with Hepatitis B or C, or human immunodeficiency virus HIV-1 or HIV-2, as determined by results of testing at Screening.
✕. Female subjects who are pregnant or lactating.
What they're measuring
1
Predicted Placebo-Adjusted Change From Baseline in the Corrected QT Interval using Fridericia's Formula (QTcF) Interval (ΔΔQTcF)
Timeframe: 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.
✕. Family history of QTc prolongation or of unexplainable sudden death at \<50 years of age.
✕. History of QTc prolongation or knowledge of any kind of cardiovascular disorder/condition known to increase the possibility of QT prolongation or history of additional risk factors for Torsade de Pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome or Brugada Syndrome) or cardiac conduction disorders.
✕. History of myocardial infarction, unstable angina pectoris, cerebrovascular disease, atherosclerosis or arterial hypertension.
✕. History of rare hereditary problem of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.
✕. History of glucose 6-phosphate dehydrogenase deficiency or myasthenia gravis.