Status:
COMPLETED
A Single Dose-escalation Study of Cytisine in Adult Smokers
Lead Sponsor:
Achieve Life Sciences
Conditions:
Smoking Cessation
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The objectives of this study are: 1. To assess the tolerability and safety of cytisine as a single oral dose. 2. To define the Cmax levels associated to the occurrence of dose-limiting adverse events...
Eligibility Criteria
Inclusion
- Subjects must meet ALL of the following criteria to be eligible for inclusion into the study:
- Free written informed consent prior to any procedure required by the study.
- Male or female subjects, age ≥18 years, at the time of signing the informed consent.
- Current daily cigarette smokers (averaging at least 10 cigarettes per day in the past 30 days).
- Expired air carbon monoxide (CO) ≥10 ppm.
- Able to swallow multiple tablets at one time.
- Able to fully understand, comply with all study requirements.
Exclusion
- Subjects meeting ANY of the following exclusion criteria will NOT be eligible for inclusion into the study at screening.
- Known hypersensitivity to cytisine or any of the excipients.
- Known severe hypersensitivity to any other drug.
- Positive urinary drugs of abuse screen, determined within 28 days before cytisine/placebo dosing.
- Positive ethanol breath test.
- Clinically significant abnormal serum chemistry, hematology, coagulation or urinalysis values within 28 days of randomization (i.e. requiring treatment or monitoring).
- Clinically significant abnormalities in 12-lead echocardiogram (ECG) determined after minimum of 5 minutes in supine position within 28 days of randomization (i.e. requiring treatment or further assessment).
- Body Mass Index (BMI) classification for being underweight (\<18.5 kg/m2) or having ≥Class 2 obesity (≥35 kg/m2).
- History of acute myocardial infarction, unstable angina, stroke, cerebrovascular incident, cardiac arrhythmia, or hospitalization for congestive heart failure.
- Blood pressure ≥160/100 mmHg, measured on the dominant arm, after at least 3 minutes in supine position.
- Creatinine clearance (CrCl) \<80 mL/min (estimated with the Cockroft-Gault equation).
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>2.0 x the upper limit of normal (ULN).
- Any inability to comply with study restrictions (See Section 9)
- Any inability or difficulty in fasting.
- Difficulty in donating blood on either arm.
- If woman of childbearing potential, positive result in serum beta-human chorionic gonadotropin (hCG) pregnancy test.
- Women who are breast-feeding.
- Subjects who do not agree to use acceptable methods of birth control during the study (See Section 9.4).
- Participation in a clinical study with an investigational drug within the previous 2 months.
- Participation in more than 2 clinical trials within the previous 12 months.
- Any other reason that the investigator views the subject should not participate or would be unable to fulfill the requirements for the study.
- Subjects meeting ANY of the following exclusion criteria will NOT be eligible for inclusion into the study at admission to each cohort.
- Any recent disease or condition or treatment that, according to the Investigator, would put the subject at undue risk due to study participation.
- Positive urinary drugs of abuse screen.
- Positive ethanol breath test.
- If female of childbearing potential, positive result in urine beta-hCG pregnancy test.
- Any other reason that the investigator views the subject should not participate or would be unable to fulfill the requirements for the study.
Key Trial Info
Start Date :
February 28 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 12 2019
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT03848208
Start Date
February 28 2019
End Date
September 12 2019
Last Update
September 17 2020
Active Locations (1)
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1
BlueClinical
Porto, Portugal, 4250-449