A Single-Center, Part-Randomized, Open-Label, Single-Dose, Three-Period, Crossover Study to Investigate the Effect of Esomeprazole and The Effect of Food on the Pharmacokinetics of Balovaptan in Healthy Volunteers
Abstract
This study will investigate the effect of food and the effect of esomeprazole on the pharmacokinetics (PK) of a single dose of balovaptan in healthy volunteers.
Conditions: Autism Spectrum Disorder.
Primary outcome: Maximum Plasma Concentration (Cmax) of Balovaptan; Mean Area Under the Concentration-Time Curve From Time Extrapolated to Infinity (AUC (0-inf)) of Balovaptan; Area Under the Concentration-Time Curve From Time 0 to 24 Hours (AUC(0-24h)) of Balovaptan; Area Under the Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of Balovaptan; Time to Reach Cmax in Plasma (Tmax) of Balovaptan; Last Quantifiable Concentration (Clast) of Balovaptan; Time To the Last Quantifiable Concentration (Tlast) of Balovaptan; Time Between Dosing and Time of First Balovaptan Plasma Concentration (Tlag); Apparent Clearance (Cl/F) of Balovaptan; Apparent Volume of Distribution (Vd/F) of Balovaptan; Terminal Elimination Phase Half-Life (T1/2) of Balovaptan; Terminal Phase Rate Constant (λz) of Balovaptan; Plasma Concentrations of Balovaptan.
Enrollment: 16 participants.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 16 participants or records.
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