Clinical TrialID 2303
A Single Dose-escalation Study of Cytisine in Adult Smokers
NCT03848208
Smoking Cessation
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Record Fields
Scalar fields from the final clinical_trial record.
- Clinical Trial Id
- 2303
- Evidence Id
- 2303
- Core Evidence Id
- 2303
- Source Clinical Trial Id
- 2277
- Herb2 Clinical Trial Id
- HBCT002277
- Nct Id
- NCT03848208
- Title
- A Single Dose-escalation Study of Cytisine in Adult Smokers
- Status
- Completed
- Phase
- Phase 1
- Study Result
- Yes
- Study Condition
- Smoking Cessation
- Study Type
- Interventional
- Study Design
- Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
- Intervention
- DRUG: cytisine|DRUG: placebo
- Intervention Allocation
- Randomized
- Intervention Model
- Parallel
- Intervention Mask
- Double
- Intervention Purpose
- Treatment
- Gender
- All
- Age
- Adult, Older_Adult
- Enrollment
- 74
- Outcome Measure
- Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Study Discontinuation, 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., From first dose of study drug through Day 6|Pharmacokinetics: Maximum Observed Plasma Concentration (Cmax), 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|Pharmacokinetics: Time to Occurrence of Cmax (Tmax), 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
- Sponsor Collaborator
- Achieve Life Sciences
- Funded By
- INDUSTRY
- Location
- BlueClinical, Porto, 4250-449, Portugal
- Other Id
- ACH-CYT-08|2018-003344-22
- Start Date
- 2019-02-28
- Primary Completion Date
- 2019-09-12
- Completion Date
- 2019-09-12
- First Posted
- 2019-02-20
- Results First Posted
- 2020-09-17
- Last Update Posted
- 2020-09-17
- Study Document
- Study Protocol, https://cdn.clinicaltrials.gov/large-docs/08/NCT03848208/Prot_000.pdf|Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/08/NCT03848208/SAP_001.pdf
- Study Url
- https://clinicaltrials.gov/study/NCT03848208
- Title Cn
- Title En
- A Single Dose-escalation Study of Cytisine in Adult Smokers
- Bilingual Status
- semi_complete