Trials / Completed
CompletedNCT05981768
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 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
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- Achieve Life Sciences · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Cytisinicline | film-coated oral tablets containing 3 mg cytisinicline |
Timeline
- Start date
- 2023-08-08
- Primary completion
- 2023-09-21
- Completion
- 2023-09-21
- First posted
- 2023-08-08
- Last updated
- 2023-10-18
Locations
1 site across 1 country: Portugal
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05981768. Inclusion in this directory is not an endorsement.