Safety Study of Cytisinicline in Adult Combustible And/or E-cigarette Smokers

Launched by ACHIEVE LIFE SCIENCES · May 24, 2024

Keywords

ClinConnect Summary

No description provided

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Prior participation in the ORCA-2, ORCA-3 or ORCA-V1 clinical studies.
• • 2. Former ORCA-2/ORCA-3 and ORCA-V1 subjects who are current daily cigarette smokers and/or daily nicotine-containing electronic cigarette users. Amount of daily combustible and/or nicotine containing electronic cigarette use at baseline is determined by subject self-report.
• • 3. At Screening, subjects must have expired carbon monoxide (CO) ≥10 ppm if self-reporting as smokers or ≥30 ng/mL cotinine using a point-of-care cotinine oral fluid screening device if self-reporting as users of nicotine containing electronic cigarettes.
• • 4. Willing to initiate cytisinicline treatment on the day after enrollment and set a quit date within 14 days of starting treatment.
• • 5. Willing to actively participate in the study's cessation behavioral support provided throughout the study.
• • 6. Able to fully understand study requirements, willing to participate, and comply with dosing schedule.
• • 7. Sign the Informed Consent Form.
• Exclusion Criteria:
• • 1. Known hypersensitivity to cytisinicline or any of the excipients.
• • 2. Clinically significant abnormal screening serum chemistry or hematology values.
• • 3. Clinically significant abnormal screening 12-lead ECG determined after minimum of 5 minutes in supine position (ie, requiring treatment or further assessment).
• • 4. Recent history (within 3 months prior to screening) of acute myocardial infarction, unstable angina, stroke, cerebrovascular incident or hospitalization for congestive heart failure.
• • 5. Current uncontrolled hypertension (systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg).
• • 6. Currently psychotic or having had a psychotic event within 3 months prior to screening; currently having suicidal ideation or risk for suicide (corresponding to question 4 or 5 on the screening C-SSRS OR "Yes" to any suicidal behavior question on the screening C-SSRS with clear suicidal intent or previous attempt); or current symptoms of moderate to severe depression (depression score ≥11 on the HADS) at screening. If any subject becomes psychotic during the study, they must be removed from cytisinicline treatment and/or additional study visits.
• • 7. Severe renal impairment defined as a creatinine clearance (CrCl) \<60 mL/min on screening lab (estimated with the Cockroft-Gault equation).
• • 8. Hepatic impairment defined as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>2.0 x the upper limit of normal (ULN) on screening lab.
• • 9. Women who are pregnant or breast-feeding.
• 10. Female subjects of childbearing potential who do not agree to use acceptable methods of birth control during the study. Acceptable methods of birth control include:
• • True abstinence: When this is in line with the preferred and usual lifestyle of the subject. \[Periodic abstinence (eg, calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception\].
• * Barrier methods:
• • diaphragm
• • cervical cap
• • contraceptive sponge
• * Hormonal methods:
• • Oral contraceptives
• • Vaginal ring such as NuvaRing
• • Skin patch such as Xulane
• • Injection such as Depro-Provera
• • Implantable rod such as Nexplanon
• • 11. Participation in a clinical study with an investigational drug in the 4 weeks prior to enrollment.
• • 12. Any other reason that the investigator views the subject should not participate or would be unable to fulfill the requirements for the study.

Trial Officials