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A Single Dose-escalation Study of Cytisine in Adult Smokers

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ClinicalTrials.gov Identifier: NCT03848208
Recruitment Status : Recruiting
First Posted : February 20, 2019
Last Update Posted : August 16, 2019
Sponsor:
Information provided by (Responsible Party):
Achieve Life Sciences

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 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
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : October 31, 2019

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 Name: Tabex

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 Name: Tabex

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 Name: Tabex

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 Name: Tabex

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 Name: Tabex

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 Name: Tabex

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 Name: Tabex

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 Name: Tabex

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 Name: Tabex

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




Primary Outcome Measures :
  1. Number of Participants With Adverse Events (AEs), Serious AEs, and AEs Leading to Study Discontinuation [ Time Frame: Through Day 6 ]
  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 ]


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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 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-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.

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


Contacts
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Contact: Daniel Cain, Sr Directory Clinical Research 425.686.1546 dcain@achievelifesciences.com

Locations
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Portugal
Hospital da Prelada Recruiting
Porto, Portugal, 4250-449
Contact: Marlene Fonseca, MD         
Sponsors and Collaborators
Achieve Life Sciences
Investigators
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Principal Investigator: Marlene Fonseca, MD Hospital da Prelada

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Responsible Party: Achieve Life Sciences
ClinicalTrials.gov Identifier: NCT03848208     History of Changes
Other Study ID Numbers: ACH-CYT-08
First Posted: February 20, 2019    Key Record Dates
Last Update Posted: August 16, 2019
Last Verified: August 2019
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