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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
SINGLE
Enrollment
17
Encapsulated tablet
Vortioxetine placebo-matching capsules.
Unnamed facility
Glendale, California, United States
Area Under the Effect Curve From Time Zero to 24 Hours Postdose of 5-hydroxytryptamine (5-HT) in Plasma
The area under the effect-time curve from time 0 to 24 hours postdose (AUEC\[0-24\]) of the neurotransmitter 5-HT (serotonin) in plasma was measured at Baseline, after a single dose (Day 1) and after multiple doses (Day 14).
Time frame: Day -1 (Baseline), Day 1 and Day 14. Blood samples were taken predose (up to 15 minutes prior) and at 1, 2, 4, 8, 12, 16 and 24 hours post-dose.
Maximum Concentration of 5-HT in Plasma
The maximum observed effect (Emax), assessed by the maximum observed concentration of 5-HT in plasma measured at Baseline, after a single dose (Day 1) and after multiple doses (Day 14).
Time frame: Day -1 (Baseline), Day 1 and Day 14. Blood samples were taken predose (up to 15 minutes prior) and at 1, 2, 4, 8, 12, 16 and 24 hours post-dose.
Time to Maximum Concentration of 5-HT in Plasma
The time to reach maximum pharmacodynamic effect (Emax) was assessed by the time to maximum concentration of 5-HT in plasma at Baseline, after a single dose (Day 1) and after multiple doses (Day 14).
Time frame: Day -1 (Baseline), Day 1 and Day 14. Blood samples were taken predose and at 1, 2, 4, 8, 12, 16, and 24 hours postdose.
Area Under the Effect Curve From Time Zero to 24 Hours Postdose of 5-HT in Cerebrospinal Fluid
The area under the effect-time curve from time 0 to 24 hours postdose (AUEC\[0-24\]) of 5-hydroxytryptamine (5-HT) in cerebrospinal fluid (CSF) was measured at Baseline, after a single dose (Day 1) and after multiple doses (Day 14).
Time frame: Day -1 (Baseline), Day 1 and Day 14. CSF samples were taken prior to dose and at 1, 2, 4, 8, 12, 16, and 24 hours postdose.
Maximum Concentration of 5-HT in Cerobrospinal Fluid
The maximum observed effect (Emax), assessed by the maximum concentration of 5-HT in cerebrospinal fluid (CSF) measured at Baseline, after a single dose (Day 1) and after multiple doses (Day 14).
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Time frame: Day -1 (Baseline), Day 1 and Day 14. CSF samples were taken prior to dose and at 1, 2, 4, 8, 12, 16, and 24 hours postdose.
Time to Maximum Concentration of 5-HT in Cerebrospinal Fluid
The time to reach maximum pharmacodynamic effect (Emax) was assessed by the time to maximum concentration of 5-HT in cerebrospinal fluid (CSF) at Baseline, after a single dose (Day 1) and after multiple doses (Day 14).
Time frame: Day -1, Day 1 and Day 14. CSF samples were taken predose and at 1, 2, 4, 8, 12, 16, and 24 hours postdose.
Area Under the Effect Curve From Time Zero to 24 Hours Postdose of 5-hydroxyindoleacetic Acid (5-HIAA) in Plasma
Area under the effect-time curve from time 0 to 24 hours postdose (AUEC\[0-24\]) of 5-HIAA, a metabolite of the neurotransmitter serotonin, in plasma was measured after a single dose (Day 1) and after multiple doses (Day 14). Note: Plasma samples for 5-HIAA on Day -1 were lost in shipping. Therefore, no PD parameters were calculated for Day -1.
Time frame: Day 1 and Day 14. Blood samples were taken predose and at 1, 2, 4, 8, 12, 16 and 24 hours post-dose.
Maximum Concentration of 5-HIAA in Plasma
The maximum observed effect (Emax), assessed by the maximum observed concentration of 5-HIAA in plasma measured after a single dose (Day 1) and after multiple doses (Day 14). Note: Plasma samples for 5-HIAA on Day -1 were lost in shipping. Therefore, no PD parameters were calculated for Day -1
Time frame: Day 1 and Day 14. Blood samples were taken predose (up to 15 minutes prior) and at 1, 2, 4, 8, 12, 16 and 24 hours post-dose.
Time to Maximum Concentration of 5-HIAA in Plasma
The time to reach maximum pharmacodynamic effect (Emax) was assessed by the time to maximum concentration of 5-hydroxyindoleacetic acid (5-HIAA) in plasma after a single dose (Day 1) and after multiple doses (Day 14). Note: Plasma samples for 5-HIAA on Day -1 were lost in shipping. Therefore, no PD parameters were calculated for Day -1.
Time frame: Day 1 and Day 14. Blood samples were taken predose and at 1, 2, 4, 8, 12, 16 and 24 hours post-dose.
Area Under the Effect Curve From Time Zero to 24 Hours Postdose of 5-HIAA in Cerebrospinal Fluid
The area under the effect-time curve from time 0 to 24 hours postdose (AUEC\[0-24\]) of 5-hydroxyindoleacetic acid (5-HIAA) in cerebrospinal fluid (CSF) was measured at Baseline, after a single dose (Day 1) and after multiple doses (Day 14).
Time frame: Day -1 (Baseline), Day 1 and Day 14. CSF samples were taken prior to dose and at 1, 2, 4, 8, 12, 16, and 24 hours postdose.
Maximum Concentration of 5-HIAA in Cerebrospinal Fluid
The maximum observed effect (Emax), assessed by the maximum observed concentration of 5-HIAA in cerebrospinal fluid (CSF) measured at Baseline, after a single dose (Day 1) and after multiple doses (Day 14).
Time frame: Day -1 (Baseline), Day 1 and Day 14. CSF samples were taken prior to dose and at 1, 2, 4, 8, 12, 16, and 24 hours postdose.
Time to Maximum Concentration of 5-HIAA in Cerebrospinal Fluid
The time to reach maximum pharmacodynamic effect (Emax) was assessed by the time to maximum concentration of 5-hydroxyindoleacetic acid (5-HIAA) in cerebrospinal fluid (CSF) at Baseline, after a single dose (Day 1) and after multiple doses (Day 14).
Time frame: Day -1, Day 1 and Day 14. CSF samples were taken prior to dose and at 1, 2, 4, 8, 12, 16, and 24 hours postdose.