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A Single Dose-escalation Study of Cytisine in Adult Smokers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03848208
Recruitment Status : Completed
First Posted : February 20, 2019
Results First Posted : September 17, 2020
Last Update Posted : September 17, 2020
Sponsor:
Information provided by (Responsible Party):
Achieve Life Sciences

Study Description
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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.

Condition or disease Intervention/treatment Phase
Smoking Cessation Drug: cytisine Drug: placebo Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase I, Double-blind, Randomized, Placebo-controlled, Single Dose-escalation Study to Evaluate the Tolerability and Safety of Cytisine in Adult Smokers
Actual Study Start Date : February 28, 2019
Actual Primary Completion Date : September 12, 2019
Actual Study Completion Date : September 12, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 Drug: cytisine
cytisine film-coated oral tablet
Other Names:
  • Tabex
  • cytisinicline
Placebo Comparator: Cohort 1: Placebo
Placebo will be administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
 Drug: placebo
matching placebo oral tablet
Experimental: 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.
 Drug: cytisine
cytisine film-coated oral tablet
Other Names:
  • Tabex
  • cytisinicline
Placebo Comparator: Cohort 2: Placebo
Placebo will be administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
 Drug: placebo
matching placebo oral tablet
Experimental: 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.
 Drug: cytisine
cytisine film-coated oral tablet
Other Names:
  • Tabex
  • cytisinicline
Placebo Comparator: Cohort 3: Placebo
Placebo will be administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
 Drug: placebo
matching placebo oral tablet
Experimental: 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.
 Drug: cytisine
cytisine film-coated oral tablet
Other Names:
  • Tabex
  • cytisinicline
Placebo Comparator: Cohort 4: Placebo
Placebo will be administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
 Drug: placebo
matching placebo oral tablet
Experimental: 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.
 Drug: cytisine
cytisine film-coated oral tablet
Other Names:
  • Tabex
  • cytisinicline
Placebo Comparator: Cohort 5: Placebo
Placebo will be administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
 Drug: placebo
matching placebo oral tablet
Experimental: 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.
 Drug: cytisine
cytisine film-coated oral tablet
Other Names:
  • Tabex
  • cytisinicline
Placebo Comparator: Cohort 6: Placebo
Placebo will be administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
 Drug: placebo
matching placebo oral tablet
Experimental: 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.
 Drug: cytisine
cytisine film-coated oral tablet
Other Names:
  • Tabex
  • cytisinicline
Placebo Comparator: Cohort 7: Placebo
Placebo will be administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
 Drug: placebo
matching placebo oral tablet
Experimental: 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.
 Drug: cytisine
cytisine film-coated oral tablet
Other Names:
  • Tabex
  • cytisinicline
Placebo Comparator: Cohort 8: Placebo
Placebo will be administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
 Drug: placebo
matching placebo oral tablet
Experimental: 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.
 Drug: cytisine
cytisine film-coated oral tablet
Other Names:
  • Tabex
  • cytisinicline
Placebo Comparator: Cohort 9: Placebo
Placebo will be administered in the morning, orally, with 240 mL of water, after fasting overnight for at least 10 hours.
 Drug: placebo
matching placebo oral tablet


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Study Discontinuation [ Time Frame: From first dose of study drug through Day 6 ]
    An adverse event (AE) is defined as any untoward medical occurrence that does not necessarily have to have a causal relationship with the treatment. A serious AE is any untoward medical occurrence or effect, that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in persistent or significant disability or incapacity; results in a congenital abnormality or birth defect; or is an important medical event which requires medical intervention to prevent one of the above. Treatment emergent events are those that occurred after the first dose of study drug.

  2. Pharmacokinetics: Maximum Observed Plasma Concentration (Cmax) [ Time Frame: Day 1: Pre-dose (within 30 minutes prior to dosing), 15, 30, 40, 50 minutes and 1, 1.25, 1.5, 1.75, 2, 2.5, and 3 hours (+/-2 minutes) post-dose ]
  3. Pharmacokinetics: Time to Occurrence of Cmax (Tmax) [ Time Frame: Day 1: Pre-dose (within 30 minutes prior to dosing), 15, 30, 40, 50 minutes and 1, 1.25, 1.5, 1.75, 2, 2.5, and 3 hours (+/-2 minutes) post-dose ]

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Subjects must meet ALL of the following criteria to be eligible for inclusion into the study:

  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:

Subjects meeting ANY of the following exclusion criteria will NOT be eligible for inclusion into the study at screening.

  1. Known hypersensitivity to cytisine or any of the excipients.
  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.

    Subjects meeting ANY of the following exclusion criteria will NOT be eligible for inclusion into the study at admission to each cohort.

  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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03848208


Locations
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Portugal
BlueClinical
Porto, Portugal, 4250-449
Sponsors and Collaborators
Achieve Life Sciences
Investigators
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Principal Investigator: Marlene Fonseca, MD Hospital da Prelada
  Study Documents (Full-Text)

Documents provided by Achieve Life Sciences:
Study Protocol  [PDF] May 7, 2019
Statistical Analysis Plan  [PDF] October 9, 2019

More Information
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Responsible Party: Achieve Life Sciences
ClinicalTrials.gov Identifier: NCT03848208    
Other Study ID Numbers: ACH-CYT-08
2018-003344-22 ( EudraCT Number )
First Posted: February 20, 2019    Key Record Dates
Results First Posted: September 17, 2020
Last Update Posted: September 17, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No