This study is designed to evaluate the potential effect of administration of tradipitant on CYP3A4 using midazolam pharmacokinetics as markers. The study will also further characterize the pharmacokinetics of tradipitant.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
24
test agent
substrate for drug-drug interaction assessment
Vanda Investigational Site
Arzo, Switzerland
Midazolam Area Under the Curve (AUC)
Time frame: Pre-dose,0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, and 72 hours
Midazolam time to maximal plasma concentration (Tmax)
Time frame: Pre-dose,0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, and 72 hours
Midazolam maximal plasma concentration (Cmax)
Time frame: Pre-dose,0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, and 72 hours
α-hydroxymidazolam area under the curve(AUC)
Time frame: pre-dose, and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours
α-hydroxymidazolam time to maximal plasma concentration (Tmax)
Time frame: pre-dose, and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24
α-hydroxymidazolam maximal plasma concentration (Cmax)
Time frame: pre-dose, and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24
Tradipitant and tradipitant metabolites area under the curve (AUC)
Time frame: pre-dose, and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24
Tradipitant and tradipitant metabolites time to maximal plasma concentration (Tmax)
Time frame: pre-dose, and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24
Tradipitant and tradipitant metabolites maximal plasma concentration (Cmax)
Time frame: pre-dose, and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24
Safety of multiple oral doses of tradipitant alone and in combination with midazolam by spontaneous reporting of AEs measured by events related to treatment.
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Time frame: 19 days
Safety of multiple oral doses of tradipitant alone and in combination with midazolam by number of participants with abnormal laboratory values
Time frame: 19 days
Safety of multiple oral doses of tradipitant alone and in combination with midazolam by number of participants with abnormal ECG values
Time frame: 19 days
Safety of multiple oral doses of tradipitant alone and in combination with midazolam by number of participants with abnormal vital signs
Time frame: 19 days
• The Columbia Suicide Severity Rating Scale will be used to assess suicidal behavior and ideation
Time frame: Baseline, Day 10, Day 19