At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 16 enrolled
Drug / intervention
Balovaptan +1 moredrug
Likely dose
Balovaptan 40 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 1 clinical trial evaluating Balovaptan and Esomeprazole for Autism Spectrum Disorder. Completed, enrolled 16 participants across 1 site.
Detailed Summary
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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAutism Spectrum Disorder
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
2020202120222023202420252026
First PostedNov 2019
Enrollment StartNov 2019
Primary CompletionDec 2019
Study CompletionJan 2020
TodayJul 2026
First PostedNov 7, 2019
Enrollment StartNov 19, 2019
Primary CompletionDec 24, 2019
Study CompletionJan 6, 2020
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 6.7 years ago
Interventions
Balovaptandrug
Balovaptan will be administered after a high-fat, high-calorie meal (Treatment A), after a 10-hour fast (Treatment B), and after a 10-hour fast with esomeprazole 40 mg (Treatment C)
Esomeprazoledrug
Esomeprazole will be administered once daily for 6 days and with a single dose of balovaptan 1 hour after the fifth esomeprazole dose