Trials / Completed
CompletedNCT03848208
A Single Dose-escalation Study of Cytisine in Adult Smokers
A Phase I, Double-blind, Randomized, Placebo-controlled, Single Dose-escalation Study to Evaluate the Tolerability and Safety of Cytisine in Adult Smokers
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 74 (actual)
- Sponsor
- Achieve Life Sciences · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | cytisine | cytisine film-coated oral tablet |
| DRUG | placebo | matching placebo oral tablet |
Timeline
- Start date
- 2019-02-28
- Primary completion
- 2019-09-12
- Completion
- 2019-09-12
- First posted
- 2019-02-20
- Last updated
- 2020-09-17
- Results posted
- 2020-09-17
Locations
1 site across 1 country: Portugal
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03848208. Inclusion in this directory is not an endorsement.