Trials / Completed
CompletedNCT03072056
A Pharmacokinetic Study of MIN-101 and Its Metabolites in Healthy Subjects to Compare MIN-101 in Poor and Extensive Metabolizers
A Phase 1, Open-Label, 3-Period, Single-Ascending Dose, Crossover Study in Healthy Subjects to Compare PK Properties of MIN-101 and Its Metabolites Poor and Extensive Metabolizers as Defined by Cytochrome P450 2D6 Genotype
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 23 (actual)
- Sponsor
- Minerva Neurosciences · Industry
- Sex
- All
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
Summary
* To evaluate the pharmacokinetic (PK) profile of MIN-101 and its metabolites in extensive (EM) and poor (PM) metabolizers * To evaluate the relationship between plasma levels of MIN-101 and changes in QT/QTcF intervals * To evaluate safety and tolerability of MIN-101.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | MIN-101 |
Timeline
- Start date
- 2017-01-09
- Primary completion
- 2017-07-07
- Completion
- 2017-07-07
- First posted
- 2017-03-07
- Last updated
- 2017-08-31
Locations
1 site across 1 country: Ireland
Source: ClinicalTrials.gov record NCT03072056. Inclusion in this directory is not an endorsement.