NCT04156646View on ClinicalTrials.gov

A Study to Investigate the Effect of Esomeprazole and the Effect of Food on the Pharmacokinetics of Balovaptan in Healthy Volunteers

PHASE1CompletedINTERVENTIONAL
Enrollment

16

Participants

Timeline

Start Date

November 19, 2019

Primary Completion Date

December 24, 2019

Study Completion Date

January 6, 2020

Conditions
Autism Spectrum Disorder
Interventions
DRUG

Balovaptan

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)

DRUG

Esomeprazole

Esomeprazole will be administered once daily for 6 days and with a single dose of balovaptan 1 hour after the fifth esomeprazole dose

Trial Locations (1)

66219

PRA International Clinical Pharmacology Center (EDS US Clinic), Lenexa

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT04156646 - A Study to Investigate the Effect of Esomeprazole and the Effect of Food on the Pharmacokinetics of Balovaptan in Healthy Volunteers | Biotech Hunter | Biotech Hunter