Trials / Completed
CompletedNCT05566288
Study to Evaluate Electrocardiographic Effects of Therapeutic & Supratherapeutic Doses of Cytisinicline in Healthy Smokers
A Four Way Crossover Thorough QT/QTc Study to Evaluate the Electrocardiographic Effects of Therapeutic and Supratherapeutic Doses of Cytisinicline in Healthy Smokers
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 27 (actual)
- Sponsor
- Achieve Life Sciences · Industry
- Sex
- All
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
Summary
The primary objective of this trial is to assess the effects of cytisinicline at therapeutic and supratherapeutic doses on cardiac repolarization relative to placebo in healthy adult subjects who are smokers.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Cytisinicline | compressed film-coated tablet containing 3 mg cytisinicline |
| DRUG | Placebo | Placebo tablets to match compressed film-coated tablet containing 3 mg cytisinicline |
| DRUG | Moxifloxacin | 400 mg tablets |
Timeline
- Start date
- 2022-10-17
- Primary completion
- 2022-12-23
- Completion
- 2022-12-23
- First posted
- 2022-10-04
- Last updated
- 2023-05-18
Locations
1 site across 1 country: Portugal
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05566288. Inclusion in this directory is not an endorsement.