The purpose of this study is to evaluate the pharmacokinetics of vortioxetine and its metabolites Lu AA34443 and Lu AA39835 following a single oral dose administration of vortioxetine 5 mg in participants with severe hepatic impairment compared to healthy participants.
The drug being tested in this study is called vortioxetine. Vortioxetine is being tested to assess how it moves throughout the body in people with severe hepatic impairment compared to people with normal hepatic function. This study looked at lab results in people who took vortioxetine. The study enrolled 12 participants. Participants were assigned to one of the two treatment groups based on their hepatic function (severe hepatic impairment vs. normal hepatic function). All participants in both groups will receive one vortioxetine 5-mg tablet. This single-center trial was conducted in the United States. The overall time to participate in this study was up to 58 days. Participants made 2 visits to the clinic, including one 12-day period of confinement to the clinic, and were contacted by telephone 30 days after last dose of study drug for a follow-up assessment.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Vortioxetine tablets
University of Miami
Miami, Florida, United States
AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Vortioxetine
(AUC(0-tlqc) is a measure of total plasma exposure to the drug from time 0 to time of the last quantifiable concentration (AUC\[0-tlqc\]).
Time frame: Predose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, and 240 hours postdose
AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Vortioxetine Metabolite Lu AA34443
(AUC(0-tlqc) is a measure of total plasma exposure to the drug from time 0 to time of the last quantifiable concentration (AUC\[0-tlqc\]).
Time frame: Predose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, and 240 hours postdose
AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Vortioxetine Metabolite Lu AA39835
(AUC(0-tlqc) is a measure of total plasma exposure to the drug from time 0 to time of the last quantifiable concentration (AUC\[0-tlqc\]).
Time frame: Predose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, and 240 hours postdose
AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Vortioxetine
AUC(0-inf) is a measure of total plasma exposure to the drug from time zero extrapolated to infinity.
Time frame: Predose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, and 240 hours postdose
AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Vortioxetine Metabolite Lu AA34443
AUC(0-inf) is a measure of total plasma exposure to the drug from time zero extrapolated to infinity.
Time frame: Predose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, and 240 hours postdose
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Cmax: Maximum Observed Plasma Concentration for Vortioxetine
Maximum Observed Plasma Concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.
Time frame: Predose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, and 240 hours postdose
Cmax: Maximum Observed Plasma Concentration for Vortioxetine Metabolite Lu AA34443
Maximum Observed Plasma Concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.
Time frame: Predose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, and 240 hours postdose
Cmax: Maximum Observed Plasma Concentration for Vortioxetine Metabolite Lu AA39835
Maximum Observed Plasma Concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.
Time frame: Predose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, and 240 hours postdose
AUC(0-tlqc)u: Area Under the Unbound Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Vortioxetine
AUC(0-tlqc)u is a measure of total unbound plasma exposure to the drug from time 0 to time of the last quantifiable concentration (AUC\[0-tlqc\]u).
Time frame: Predose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, and 240 hours postdose
AUC(0-inf)u: Area Under the Unbound Plasma Concentration-time Curve From Time 0 to Infinity for Vortioxetine
AUC(0-inf)u is a measure of total unbound plasma exposure to the drug from time zero extrapolated to infinity.
Time frame: Predose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, and 240 hours postdose
Cmaxu: Maximum Observed Unbound Plasma Concentration for Vortioxetine
Maximum Observed Unbound Plasma Concentration (Cmaxu) is the peak unbound plasma concentration of a drug after administration, obtained directly from the unbound plasma concentration-time curve.
Time frame: Predose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, and 240 hours postdose