A Single Dose-escalation Study of Cytisine in Adult Smokers
NCT ID: NCT03848208
Last Updated: 2020-09-17
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE1
74 participants
INTERVENTIONAL
2019-02-28
2019-09-12
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Cohort 1: Cytisine 6.0 mg
Cytisine will be administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
cytisine
cytisine film-coated oral tablet
Cohort 1: Placebo
Placebo will be administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
placebo
matching placebo oral tablet
Cohort 2: Cytisine 9.0 mg
Cytisine will be administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
cytisine
cytisine film-coated oral tablet
Cohort 2: Placebo
Placebo will be administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
placebo
matching placebo oral tablet
Cohort 3: Cytisine 12.0 mg
Cytisine will be administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
cytisine
cytisine film-coated oral tablet
Cohort 3: Placebo
Placebo will be administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
placebo
matching placebo oral tablet
Cohort 4: Cytisine 15.0 mg
Cytisine will be administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
cytisine
cytisine film-coated oral tablet
Cohort 4: Placebo
Placebo will be administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
placebo
matching placebo oral tablet
Cohort 5: Cytisine 18.0 mg
Cytisine will be administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
cytisine
cytisine film-coated oral tablet
Cohort 5: Placebo
Placebo will be administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
placebo
matching placebo oral tablet
Cohort 6: Cytisine 21.0 mg
Cytisine will be administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
cytisine
cytisine film-coated oral tablet
Cohort 6: Placebo
Placebo will be administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
placebo
matching placebo oral tablet
Cohort 7: Cytisine 24.0 mg
Cytisine will be administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
cytisine
cytisine film-coated oral tablet
Cohort 7: Placebo
Placebo will be administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
placebo
matching placebo oral tablet
Cohort 8: Cytisine 27.0 mg
Cytisine will be administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
cytisine
cytisine film-coated oral tablet
Cohort 8: Placebo
Placebo will be administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
placebo
matching placebo oral tablet
Cohort 9: Cytisine 30.0 mg
Cytisine will be administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
cytisine
cytisine film-coated oral tablet
Cohort 9: Placebo
Placebo will be administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
placebo
matching placebo oral tablet
Interventions
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cytisine
cytisine film-coated oral tablet
placebo
matching placebo oral tablet
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. Free written informed consent prior to any procedure required by the study.
2. Male or female subjects, age ≥18 years, at the time of signing the informed consent.
3. Current daily cigarette smokers (averaging at least 10 cigarettes per day in the past 30 days).
4. Expired air carbon monoxide (CO) ≥10 ppm.
5. Able to swallow multiple tablets at one time.
6. Able to fully understand, comply with all study requirements.
Exclusion Criteria
2. Known severe hypersensitivity to any other drug.
3. Positive urinary drugs of abuse screen, determined within 28 days before cytisine/placebo dosing.
4. Positive ethanol breath test.
5. Clinically significant abnormal serum chemistry, hematology, coagulation or urinalysis values within 28 days of randomization (i.e. requiring treatment or monitoring).
6. 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).
7. Body Mass Index (BMI) classification for being underweight (\<18.5 kg/m2) or having ≥Class 2 obesity (≥35 kg/m2).
8. History of acute myocardial infarction, unstable angina, stroke, cerebrovascular incident, cardiac arrhythmia, or hospitalization for congestive heart failure.
9. Blood pressure ≥160/100 mmHg, measured on the dominant arm, after at least 3 minutes in supine position.
10. Creatinine clearance (CrCl) \<80 mL/min (estimated with the Cockroft-Gault equation).
11. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>2.0 x the upper limit of normal (ULN).
12. Any inability to comply with study restrictions (See Section 9)
13. Any inability or difficulty in fasting.
14. Difficulty in donating blood on either arm.
15. If woman of childbearing potential, positive result in serum beta-human chorionic gonadotropin (hCG) pregnancy test.
16. Women who are breast-feeding.
17. Subjects who do not agree to use acceptable methods of birth control during the study (See Section 9.4).
18. Participation in a clinical study with an investigational drug within the previous 2 months.
19. Participation in more than 2 clinical trials within the previous 12 months.
20. Any other reason that the investigator views the subject should not participate or would be unable to fulfill the requirements for the study.
21. Any recent disease or condition or treatment that, according to the Investigator, would put the subject at undue risk due to study participation.
22. Positive urinary drugs of abuse screen.
23. Positive ethanol breath test.
24. If female of childbearing potential, positive result in urine beta-hCG pregnancy test.
25. Any other reason that the investigator views the subject should not participate or would be unable to fulfill the requirements for the study.
18 Years
ALL
Yes
Sponsors
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Achieve Life Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Marlene Fonseca, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital da Prelada
Locations
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BlueClinical
Porto, , Portugal
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2018-003344-22
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ACH-CYT-08
Identifier Type: -
Identifier Source: org_study_id
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