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The Effect of Hepatic Impairment on the Pharmacokinetics of Balovaptan

Autism Spectrum Disorder Clinical Trial

Official title:
The Effect of Hepatic Impairment on the Pharmacokinetics of Balovaptan: A Phase I, Multiple-Center, Open-Label Study Following Multiple Daily Oral Doses of Balovaptan in Subjects With Moderate Hepatic Impairment and Healthy Subjects With Normal Hepatic Function

Clinical Trial Summary

This is a multi-center, non-randomized, open-label, parallel group, multiple-dose study to assess the pharmacokinetic, safety, and tolerability of balovaptan in male and female subjects with moderate hepatic impairment compared to healthy subjects with normal hepatic function matched by age (±10 years), sex, and body mass index (BMI; ±20%).

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03912350
Study type Interventional
Source Hoffmann-La Roche
Contact
Status Withdrawn
Phase Phase 1
Start date June 26, 2022
Completion date October 13, 2022
View Details
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