Smoking CessationPhase 1NCT05981768
Study to Evaluate Effect of Food on Bioavailability of Single 3 mg Tablet and Pharmacokinetics (PK) of Multiple 3 mg Doses in Healthy Adult Smokers
A Phase 1 study testing Cytisinicline in people with Smoking Cessation, run by Achieve Life Sciences at 1 site in Portugal.
Trial summary
To assess the effect of food on the bioavailability of 3 mg cytisinicline following single-dose administration, and to evaluate the PK profile of 3 mg cytisinicline TID following multiple days of administration during Days 5-8. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Cytisinicline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePortugal
- Study dates
- 8 Aug 2023to 21 Sep 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Free written informed consent prior to any procedure required by the study.
- Willingness to accept and comply with all study procedures and restrictions.
- Male or female subject ≥ 18 years, at the date of signing the informed consent.
- Regular moderate combustible cigarette smokers (self-reported average of at least 10 cigarettes per day).
- Body mass index (BMI) of 18.0 to 30.0 kg/m^2, inclusive.
- Healthy subject, based on medical history, physical examination, vital signs, ECG and clinical laboratory tests.
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- Negative test results for anti-human immunodeficiency virus 1 and 2 antibodies (anti-HIV-1Ab and anti-HIV-2Ab), Hepatitis B surface antigen (HBsAg) and anti-hepatitis C virus antibodies (anti-HCVAb).
- A female subject is eligible if she also meets one of the following criteria:
- is of non-childbearing potential (underwent a permanent sterilization method [eg, hysterectomy, bilateral salpingectomy or bilateral oophorectomy], is clinically diagnosed infertile, or is in a post-menopausal state); or
- is of childbearing potential and agrees to use an accepted contraceptive method from at least 4 weeks prior to admission and until at least 4 weeks after the last dose administration (Day 8).
Who cannot join
- AT SCREENING
- Known hypersensitivity/allergic reaction to cytisinicline or any of the excipients.
- Known severe hypersensitivity reaction to any other drug.
- Any medical condition (eg, gastrointestinal, renal or hepatic, including peptic ulcer, inflammatory bowel disease or pancreatitis) or surgical condition (eg, cholecystectomy, gastrectomy) that may affect drug pharmacokinetics (absorption, distribution, metabolism or excretion) or subject safety.
- Stroke or acute myocardial infarction within the previous 3 months.
- History of hyperthyroidism.
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- History of psychosis or of a psychotic event.
- Estimated renal creatinine clearance (CLCr) below the lower limit of the normal range (ie, 90-120 mL/min/1.73 m^2 for males and 80-110 mL/min/1.73 m^2 for females), based on creatinine clearance calculation by the Cockcroft-Gault formula and normalized to an average body surface area of 1.73 m^2.
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) above the upper limit of the normal (ULN) range.
- Positive result in urine drugs-of-abuse or ethanol tests at Screening.
- Excessive caffeine consumption, defined as ≥ 800 mg per day.
- Veins unsuitable for intravenous puncture on either arm (eg, veins that are difficult to locate, access or puncture; veins with a tendency to rupture during or after puncture).
- Participation in any clinical trial within the previous 2 months.
- Use of any smoking cessation medications such as cytisinicline, bupropion, varenicline, nortriptyline, or any nicotine replacement therapy (NRT; eg, nicotine patch, nicotine chewing gum, or electronic cigarettes) in the previous 8 weeks.
- Participation in more than 2 clinical trials within the previous 12 months.
- Blood donation or significant blood loss (≥ 450 mL) due to any reason or had plasmapheresis within the previous 2 months.
- Female subjects who are lactating or pregnant by serum pregnancy test.
- Any other condition that the investigator considers the subject to be unsuitable for the study.
- AT ADMISSION
- Any recent disease or condition or treatment that, according to the investigator, would put the subject at undue risk due to study participation or occurred at a time frame in which may interfere with the pharmacokinetics of study drug.
- Use of any medicinal products, prescription and non-prescription (including vitamins, food supplements, herbal supplements [including St John's Wort]), in the previous 2 weeks, unless in the investigator's opinion the medication does not interfere with the pharmacokinetics of study drug or compromise subject safety.
- NOTE: The use of topical products without systemic absorption, acetaminophen (paracetamol) at doses of ≤ 2 grams/day, and hormonal contraceptives are acceptable.
- Use of any smoking cessation medications (eg, cytisinicline, bupropion, varenicline, nortriptyline, or any NRT eg, nicotine patch, nicotine chewing gum, or electronic cigarettes) since Screening.
- Positive result in drugs-of-abuse or ethanol tests.
- If female, positive pregnancy test in urine.
- Any other condition that the investigator considers to render the subject unsuitable for the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Study to Investigate the Effect of Food on the Bioavailability of a Single Cytisinicline 3 mg Tablet and Evaluation of the Pharmacokinetics of Multiple 3 mg Doses (Three Times Daily) in Healthy Adult Smokers
To assess the effect of food on the bioavailability of 3 mg cytisinicline following single-dose administration, and to evaluate the PK profile of 3 mg cytisinicline TID following multiple days of administration during Days 5-8.
- Conditions
- Smoking Cessation
- Being tested
- Cytisinicline
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CytisiniclineDrug
Also called Cytisine
film-coated oral tablets containing 3 mg cytisinicline
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Cytisinicline 3 mg Once Daily (QD), Fasting | Experimental | 3 mg cytisinicline tablet administered in the morning, between 7:00 and 9:00 AM, in fasting conditions on Day 1 (Period 1) or Day 3 (Period 2). Participants will fast overnight for at least 10 hours before cytisinicline administration and will continue to fast for 4 hours after dosing. Receives: Drug: Cytisinicline |
| Part 1: Cytisinicline 3 mg QD, Fed | Experimental | 3 mg cytisinicline tablet administered in the morning, between 7:00 and 9:00 AM, in fed conditions on Day 1 (Period 1) or Day 3 (Period 2). After an overnight fasting of at least 10 hours, participants will consume a standard high-fat-high-calorie meal within 30 minutes. Cytisinicline will be administered with 240 mL of water within 5 minutes after completion of the meal. Receives: Drug: Cytisinicline |
| Part 2: Cytisinicline 3 mg 3 Times Daily (TID) | Experimental | 3 mg cytisinicline tablet administered TID each day on Day 5 to 8 (Period 3) as follows: Dose 1 will be administered in the morning between 7:00 and 9:00 AM,; Dose 2 at 5 hours (±10 minutes) after Dose 1; Dose 3 at 5 hours (±10 minutes) after Dose 2. Cytisinicline will be administered on an empty stomach (cytisinicline given at least 2 hours before food or 1 hour after food). Receives: Drug: Cytisinicline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed Plasma Concentration (Cmax)
Measured: Day 1 (Period 1) and Day 3 (Period 2): pre-dose and up to 24 hours post-dose
Time of Maximum Observed Plasma Concentration (Tmax)
Measured: Day 1 (Period 1) and Day 3 (Period 2): pre-dose and up to 24 hours post-dose
Time Point Prior to the First Quantifiable Concentration (Tlag)
Measured: Day 1 (Period 1) and Day 3 (Period 2): pre-dose and up to 24 hours post-dose
Time of Last Quantifiable Observed Concentration (Tlast)
Measured: Day 1 (Period 1) and Day 3 (Period 2): pre-dose and up to 24 hours post-dose
Area Under Plasma Concentration-Time Curve (AUC) Over the Dosing Interval (AUC0-τ)
Measured: Day 1 (Period 1) and Day 3 (Period 2): pre-dose and up to 24 hours post-dose
AUC From Time of Dosing (t=0h) to the Time of the Last Quantifiable Concentration (AUC0-t)
Measured: Day 1 (Period 1) and Day 3 (Period 2): pre-dose and up to 24 hours post-dose
Total AUC Extrapolated to Infinity (AUC0-∞)
Measured: Day 1 (Period 1) and Day 3 (Period 2): pre-dose and up to 24 hours post-dose
Percentage of AUC0-∞ Due to Extrapolation From the Time of the Last Quantifiable Concentration (Tlast) to Infinity (%AUCextrap)
Measured: Day 1 (Period 1) and Day 3 (Period 2): pre-dose and up to 24 hours post-dose
Apparent Terminal Elimination Rate Constant (λz)
Measured: Day 1 (Period 1) and Day 3 (Period 2): pre-dose and up to 24 hours post-dose
Apparent Terminal Elimination Half-Life (t1/2)
Measured: Day 1 (Period 1) and Day 3 (Period 2): pre-dose and up to 24 hours post-dose
Apparent Clearance (CL/F)
Measured: Day 1 (Period 1) and Day 3 (Period 2): pre-dose and up to 24 hours post-dose
Apparent Volume of Distribution (V/F)
Measured: Day 1 (Period 1) and Day 3 (Period 2): pre-dose and up to 24 hours post-dose
Pre-dose Plasma Concentration (Ctrough) for Dose 1, Dose 2 and Dose 3
Measured: Days 5 to 8 (Period 3): pre-dose
Cmax for Dose 1, Dose 2 and Dose 3
Measured: Days 5-7 (Period 3): predose, Day 8 (Period 3): pre-dose and up to 5 hours post-dose (Doses 1 and 2), predose and up to 24 hours post-dose (Dose 3)
Tmax for Dose 1, Dose 2 and Dose 3
Measured: Days 5-7 (Period 3): predose, Day 8 (Period 3): pre-dose and up to 5 hours post-dose (Doses 1 and 2), predose and up to 24 hours post-dose (Dose 3)
AUC0-τ for Dose 1, Dose 2 and Dose 3
τ=5 h for Dose 1 and Dose 2 and τ=24 h for Dose 3
Measured: Days 5-7 (Period 3): predose, Day 8 (Period 3): pre-dose and up to 5 hours post-dose (Doses 1 and 2), predose and up to 24 hours post-dose (Dose 3)
Concentration Over the Dosing Interval (Cτ) for Dose 1, Dose 2 and Dose 3
τ=5 h for Dose 1 and Dose 2 and τ=24 h for Dose 3
Measured: Days 5-7 (Period 3): predose, Day 8 (Period 3): pre-dose and up to 5 hours post-dose (Doses 1 and 2), predose and up to 24 hours post-dose (Dose 3)
Apparent Terminal Elimination Half-Life Interval (t1/2) post Dose 3
Measured: Day 8 (Period 3): up to 24 hours post-dose 3
Ratio of Cmax (R[Cmax])
Accumulation of cytisinicline following TID administration will be assessed by estimating R(Cmax), where R is the ratio of the pharmacokinetic parameter following administration of Dose 1 on Day 8 vs. single-dose administration under fasting conditions during Period 1 or 2.
Measured: Day 1 (Period 1) or Day 3 (Period 2), Day 8 (Period 3): Dose 1 (up to 5 hours post-dose)
Ratio of AUC0-τ (R[AUC0-τ])
Accumulation of cytisinicline following TID administration will be assessed by estimating R(AUC0-τ), where R is the ratio of the pharmacokinetic parameter following administration of Dose 1 on Day 8 vs. single-dose administration under fasting conditions during Period 1 or 2.
Measured: Day 1 (Period 1) or Day 3 (Period 2), Day 8 (Period 3): Dose 1 (up to 5 hours post-dose)
R(AUC0-τ/AUC0-∞)
Time invariance will be assessed as R(AUC0-τ/AUC0-∞), where AUC0-τ is estimated on Day 8 Dose 1 and AUC0-∞ is estimated for the single-dose under fasting conditions during Period 1 or 2.
Measured: Day 1 (Period 1) or Day 3 (Period 2), Day 8 (Period 3): Dose 1 (up to 5 hours post-dose)
Time to Steady State
Time to steady state will be assessed by visual inspection of the Ctrough versus time plot.
Measured: Days 5 to 8 (Period 3): pre-dose
Number of Participants With Treatment Emergent Adverse Events (AEs)
Measured: From first dose of study drug through the End-of Study Visit (Day 28-31)
Number of Participants With Clinically Significant Changes From Baseline in Electrocardiograms (ECG)
Measured: Baseline through Day 9
Number of Participants With Clinically Significant Changes From Baseline in Vital Signs
Measured: Baseline through Day 9
Number of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Tests
Measured: Baseline through Day 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2023
- Study start8 Aug 2023
- Primary completion21 Sep 2023
- Study completion21 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Achieve Life Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marlene Fonseca, MD, Principal investigator, Blue Clinical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05981768
- Sponsor's protocol ID
- ACH-CYT-11
- Status last verified
- Oct 2023
- First submitted
- 1 Aug 2023
- Last updated
- 18 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study to Investigate the Effect of Food on the Bioavailability of a Single Cytisinicline 3 mg Tablet and Evaluation of the Pharmacokinetics of Multiple 3 mg Doses (Three Times Daily) in Healthy Adult Smokers
- ClinicalTrials.gov ID
- NCT05981768
- Acronym / sponsor ID
- ACH-CYT-11
- Conditions
- Smoking Cessation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Achieve Life SciencesIndustry (pharma, biotech, devices)
- Study start
- 8 Aug 2023 (actual)
- Primary completion
- 21 Sep 2023 (actual)
- Study completion
- 21 Sep 2023 (actual)
- First posted
- 8 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the effect of food on the bioavailability of 3 mg cytisinicline following single-dose administration, and to evaluate the PK profile of 3 mg cytisinicline TID following multiple days of administration during Days 5-8.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part 1: Cytisinicline 3 mg Once Daily (QD), Fasting | Experimental | Drug: Cytisinicline3 mg cytisinicline tablet administered in the morning, between 7:00 and 9:00 AM, in fasting conditions on Day 1 (Period 1) or Day 3 (Period 2). Participants will fast overnight for at least 10 hours before cytisinicline administration and will continue to fast for 4 hours after dosing. |
| Part 1: Cytisinicline 3 mg QD, Fed | Experimental | Drug: Cytisinicline3 mg cytisinicline tablet administered in the morning, between 7:00 and 9:00 AM, in fed conditions on Day 1 (Period 1) or Day 3 (Period 2). After an overnight fasting of at least 10 hours, participants will consume a standard high-fat-high-calorie meal within 30 minutes. Cytisinicline will be administered with 240 mL of water within 5 minutes after completion of the meal. |
| Part 2: Cytisinicline 3 mg 3 Times Daily (TID) | Experimental | Drug: Cytisinicline3 mg cytisinicline tablet administered TID each day on Day 5 to 8 (Period 3) as follows: Dose 1 will be administered in the morning between 7:00 and 9:00 AM,; Dose 2 at 5 hours (±10 minutes) after Dose 1; Dose 3 at 5 hours (±10 minutes) after Dose 2. Cytisinicline will be administered on an empty stomach (cytisinicline given at least 2 hours before food or 1 hour after food). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Free written informed consent prior to any procedure required by the study.
- Willingness to accept and comply with all study procedures and restrictions.
- Male or female subject ≥ 18 years, at the date of signing the informed consent.
- Regular moderate combustible cigarette smokers (self-reported average of at least 10 cigarettes per day).
- Body mass index (BMI) of 18.0 to 30.0 kg/m^2, inclusive.
Key exclusion criteria (26 listed)
- AT SCREENING
- Known hypersensitivity/allergic reaction to cytisinicline or any of the excipients.
- Known severe hypersensitivity reaction to any other drug.
- Any medical condition (eg, gastrointestinal, renal or hepatic, including peptic ulcer, inflammatory bowel disease or pancreatitis) or surgical condition (eg, cholecystectomy, gastrectomy) that may affect drug pharmacokinetics (absorption, distribution, metabolism or excretion) or subject safety.
- Stroke or acute myocardial infarction within the previous 3 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CytisiniclineAlso: Cytisinefilm-coated oral tablets containing 3 mg cytisinicline | Drug | Part 1: Cytisinicline 3 mg Once Daily (QD), Fasting, Part 1: Cytisinicline 3 mg QD, Fed, Part 2: Cytisinicline 3 mg 3 Times Daily (TID) |
Primary outcome
Maximum Observed Plasma Concentration (Cmax)
Time frame: Day 1 (Period 1) and Day 3 (Period 2): pre-dose and up to 24 hours post-dose
Time of Maximum Observed Plasma Concentration (Tmax)
Time frame: Day 1 (Period 1) and Day 3 (Period 2): pre-dose and up to 24 hours post-dose
Time Point Prior to the First Quantifiable Concentration (Tlag)
Time frame: Day 1 (Period 1) and Day 3 (Period 2): pre-dose and up to 24 hours post-dose
Time of Last Quantifiable Observed Concentration (Tlast)
Time frame: Day 1 (Period 1) and Day 3 (Period 2): pre-dose and up to 24 hours post-dose
Area Under Plasma Concentration-Time Curve (AUC) Over the Dosing Interval (AUC0-τ)
Time frame: Day 1 (Period 1) and Day 3 (Period 2): pre-dose and up to 24 hours post-dose
AUC From Time of Dosing (t=0h) to the Time of the Last Quantifiable Concentration (AUC0-t)
Time frame: Day 1 (Period 1) and Day 3 (Period 2): pre-dose and up to 24 hours post-dose
Total AUC Extrapolated to Infinity (AUC0-∞)
Time frame: Day 1 (Period 1) and Day 3 (Period 2): pre-dose and up to 24 hours post-dose
Percentage of AUC0-∞ Due to Extrapolation From the Time of the Last Quantifiable Concentration (Tlast) to Infinity (%AUCextrap)
Time frame: Day 1 (Period 1) and Day 3 (Period 2): pre-dose and up to 24 hours post-dose
Apparent Terminal Elimination Rate Constant (λz)
Time frame: Day 1 (Period 1) and Day 3 (Period 2): pre-dose and up to 24 hours post-dose
Apparent Terminal Elimination Half-Life (t1/2)
Time frame: Day 1 (Period 1) and Day 3 (Period 2): pre-dose and up to 24 hours post-dose
Apparent Clearance (CL/F)
Time frame: Day 1 (Period 1) and Day 3 (Period 2): pre-dose and up to 24 hours post-dose
Apparent Volume of Distribution (V/F)
Time frame: Day 1 (Period 1) and Day 3 (Period 2): pre-dose and up to 24 hours post-dose
Pre-dose Plasma Concentration (Ctrough) for Dose 1, Dose 2 and Dose 3
Time frame: Days 5 to 8 (Period 3): pre-dose
Cmax for Dose 1, Dose 2 and Dose 3
Time frame: Days 5-7 (Period 3): predose, Day 8 (Period 3): pre-dose and up to 5 hours post-dose (Doses 1 and 2), predose and up to 24 hours post-dose (Dose 3)
Tmax for Dose 1, Dose 2 and Dose 3
Time frame: Days 5-7 (Period 3): predose, Day 8 (Period 3): pre-dose and up to 5 hours post-dose (Doses 1 and 2), predose and up to 24 hours post-dose (Dose 3)
AUC0-τ for Dose 1, Dose 2 and Dose 3
Time frame: Days 5-7 (Period 3): predose, Day 8 (Period 3): pre-dose and up to 5 hours post-dose (Doses 1 and 2), predose and up to 24 hours post-dose (Dose 3)
τ=5 h for Dose 1 and Dose 2 and τ=24 h for Dose 3
Concentration Over the Dosing Interval (Cτ) for Dose 1, Dose 2 and Dose 3
Time frame: Days 5-7 (Period 3): predose, Day 8 (Period 3): pre-dose and up to 5 hours post-dose (Doses 1 and 2), predose and up to 24 hours post-dose (Dose 3)
τ=5 h for Dose 1 and Dose 2 and τ=24 h for Dose 3
Apparent Terminal Elimination Half-Life Interval (t1/2) post Dose 3
Time frame: Day 8 (Period 3): up to 24 hours post-dose 3
Ratio of Cmax (R[Cmax])
Time frame: Day 1 (Period 1) or Day 3 (Period 2), Day 8 (Period 3): Dose 1 (up to 5 hours post-dose)
Accumulation of cytisinicline following TID administration will be assessed by estimating R(Cmax), where R is the ratio of the pharmacokinetic parameter following administration of Dose 1 on Day 8 vs. single-dose administration under fasting conditions during Period 1 or 2.
Ratio of AUC0-τ (R[AUC0-τ])
Time frame: Day 1 (Period 1) or Day 3 (Period 2), Day 8 (Period 3): Dose 1 (up to 5 hours post-dose)
Accumulation of cytisinicline following TID administration will be assessed by estimating R(AUC0-τ), where R is the ratio of the pharmacokinetic parameter following administration of Dose 1 on Day 8 vs. single-dose administration under fasting conditions during Period 1 or 2.
R(AUC0-τ/AUC0-∞)
Time frame: Day 1 (Period 1) or Day 3 (Period 2), Day 8 (Period 3): Dose 1 (up to 5 hours post-dose)
Time invariance will be assessed as R(AUC0-τ/AUC0-∞), where AUC0-τ is estimated on Day 8 Dose 1 and AUC0-∞ is estimated for the single-dose under fasting conditions during Period 1 or 2.
Time to Steady State
Time frame: Days 5 to 8 (Period 3): pre-dose
Time to steady state will be assessed by visual inspection of the Ctrough versus time plot.
Number of Participants With Treatment Emergent Adverse Events (AEs)
Time frame: From first dose of study drug through the End-of Study Visit (Day 28-31)
Number of Participants With Clinically Significant Changes From Baseline in Electrocardiograms (ECG)
Time frame: Baseline through Day 9
Number of Participants With Clinically Significant Changes From Baseline in Vital Signs
Time frame: Baseline through Day 9
Number of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Tests
Time frame: Baseline through Day 9
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marlene Fonseca, MD principal investigator
Blue Clinical
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cytisinicline in people with Smoking Cessation, run by Achieve Life Sciences at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Observed Plasma Concentration (Cmax) (time frame: Day 1 (Period 1) and Day 3 (Period 2): pre-dose and up to 24 hours post-dose). The study lists 26 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2023.