NCT06435221已完成3 期
A Multicenter, Open-Label Study Assessing Long-Term Exposure With Cytisinicline 3 mg TID
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 479
- 试验地点
- 17
- 主要终点
- Incidence Rate of Treatment Emergent Serious Adverse Events (SAEs)
研究概览
简要总结
Safety assessment of long-term 3 mg cytisinicline three times daily (TID) exposure for 52 weeks is the main purpose of this study, conducted in the United States.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Prior participation in the ORCA-2, ORCA-3 or ORCA-V1 clinical studies.
- •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.
- •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.
- •Willing to initiate cytisinicline treatment on the day after enrollment and set a quit date within 14 days of starting treatment.
- •Willing to actively participate in the study's cessation behavioral support provided throughout the study.
- •Able to fully understand study requirements, willing to participate, and comply with dosing schedule.
- •Sign the Informed Consent Form.
排除标准
- •Known hypersensitivity to cytisinicline or any of the excipients.
- •Clinically significant abnormal screening serum chemistry or hematology values.
- •Clinically significant abnormal screening 12-lead ECG determined after minimum of 5 minutes in supine position (ie, requiring treatment or further assessment).
- •Recent history (within 3 months prior to screening) of acute myocardial infarction, unstable angina, stroke, cerebrovascular incident or hospitalization for congestive heart failure.
- •Current uncontrolled hypertension (systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg).
- •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.
- •Severe renal impairment defined as a creatinine clearance (CrCl) <60 mL/min on screening lab (estimated with the Cockroft-Gault equation).
- •Hepatic impairment defined as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2.0 x the upper limit of normal (ULN) on screening lab.
- •Women who are pregnant or breast-feeding.
- •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
- •Participation in a clinical study with an investigational drug in the 4 weeks prior to enrollment.
- •Any other reason that the investigator views the subject should not participate or would be unable to fulfill the requirements for the study.
研究组 & 干预措施
Cytisinicline 3 mg TID
Experimental
Cytisinicline 3 mg TID for 52 weeks.
干预措施: Cytisinicline (Drug)
结局指标
主要结局
Incidence Rate of Treatment Emergent Serious Adverse Events (SAEs)
时间窗: up to Week 52
次要结局
- Percentage of Participants With Potentially Clinically Significant Abnormal Vital Signs(up to Week 52)
- Number of Participants With Clinically Significant Abnormal Hematology and Chemistry Parameters(up to Week 52)
- Percentage of Participants With Clinically Significant Abnormal Hematology and Chemistry Parameters(up to Week 52)
- Incidence Rate of Related TEAEs(up to Week 52)
- Number of Participants With Potentially Clinically Significant Abnormal Vital Signs(up to Week 52)
- Incidence Rate of Related Treatment Emergent SAEs(up to Week 52)
- Incidence Rate of Treatment Emergent Adverse Events (TEAEs)(up to Week 52)
研究者
研究点 (17)
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