Conditions: Healthy
Keywords: Drug Therapy pharmacodynamic
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 17
Healthy volunteers: yes

Brief summary:
The purpose of this study is to evaluate the pharmacodynamics (the drug's effect on the body), the pharmacokinetics (the body's handling of the drug), and the safety and tolerability of vortioxetine, once daily (QD) in healthy men.

Detailed description:
This study will look at an investigational medicine called vortioxetine to see how the drug affects the body and how the body handles the drug.

The study enrolled 17 patients. Participants were randomly assigned at a 2:1 ratio to one of the following two treatment groups-which remained undisclosed to both the participant and study doctor during the study (unless there was an urgent medical need):

* Vortioxetine 20 mg
* Placebo (dummy inactive pill) - this was a capsule that looked like the study drug but had no active ingredient.

All participants were asked to take one capsule at the same time each day throughout the study.

This single-center trial was conducted in the United States. The overall time to participate in this study was approximately 7 weeks. Participants made 2 visits to the clinic, including 18 days confinement to the clinic, and were contacted by telephone 1 day and 27 days after leaving confinement for a follow-up assessment.

Arms:
arm 1: Vortioxetine 20 mg, encapsulated tablet, orally, once daily for up to 14 days. arm 2: Vortioxetine placebo-matching capsules, orally, once daily for up to 14 days.

Interventions: intervention 1: Vortioxetine intervention 2: Placebo
Intervention descriptions: intervention 1: Encapsulated tablet intervention 2: Vortioxetine placebo-matching capsules.

Protocol document: