NCT03912350

The Effect of Hepatic Impairment on the Pharmacokinetics of Balovaptan

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

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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%).

Conditions

• Autism Spectrum Disorder

Interventions

Type	Name	Description
DRUG	Balovaptan	Participants will receive 1 tablet of balovaptan once daily (QD) on Days 1 through 14.

Timeline

• Start date: 2022-06-26
• Primary completion: 2022-09-24
• Completion: 2022-10-13
• First posted: 2019-04-11
• Last updated: 2022-02-08

Regulatory

• FDA-regulated drug study