Trials / Completed
CompletedNCT03551769
Pharmacokinetics of Tricaprilin Including Food Effect on Ketone Body Production
A Phase I, Open-label, Fixed-order, Single-dose, 2-Part, Crossover Study to Evaluate the Pharmacokinetics of a Formulation of Tricaprilin (AC-SD-01) Including the Effect of Food on Ketone Body Production in Caucasians and Asians
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 20 (actual)
- Sponsor
- Cerecin · Industry
- Sex
- Male
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
Summary
This is a Phase I, single center, open label, fixed-order, crossover, food-effect, pharmacokinetic (PK) study recruiting healthy, adult, male subjects.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | tricaprilin | Tricaprilin formulated as AC-SD-01 |
| OTHER | standard meal | standard meal |
| OTHER | high-fat meal | high-fat meal |
| OTHER | overnight fast | fasting for at least 9 hours |
Timeline
- Start date
- 2018-08-05
- Primary completion
- 2018-08-16
- Completion
- 2018-08-27
- First posted
- 2018-06-11
- Last updated
- 2019-05-29
Locations
1 site across 1 country: Australia
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03551769. Inclusion in this directory is not an endorsement.