CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 16 enrolled
Drug / intervention
Oral Balovaptan +1 moredrug
Likely dose
Not stated in 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.

Search/NCT03764449
NCT03764449Phase 1Completed
CompareCT.gov

A Single-Center, Non-Randomized, Open-Label, Parallel Group, Two-Treatment Study Investigating the Absolute Oral Bioavailability of Balovaptan After Single and Multiple Daily Oral Doses of Balovaptan in Healthy Volunteers

Hoffmann-La Roche·interventional·Posted Dec 5, 2018·Updated Feb 24, 2020

In Brief

A Phase 1 clinical trial evaluating Oral Balovaptan and IV Balovaptan for Healthy Volunteers. Completed, enrolled 16 participants across 1 site.

Detailed Summary

This study was a non-randomized, open-label, parallel group, two-treatment study in healthy volunteers to investigate the absolute oral bioavailability of balovaptan. The study was conducted at 1 site in the Netherlands.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Volunteers
CountriesNetherlands
Collaborators--

Timeline

Phase 1CompletedFinished
20192020202120222023202420252026
First PostedDec 5, 2018
Enrollment StartJan 10, 2019
Primary CompletionMar 4, 2019
Study CompletionMar 15, 2019
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 7.6 years ago

Interventions

Oral Balovaptandrug

In Period 1, balovaptan was administered as a single oral dose. In Period 2, balovaptan was administered as an oral dose once daily on Day 1 to Day 14.

IV Balovaptandrug

In Period 1, IV infusion of balovaptan was administered after the balovaptan oral dose. In Period 2, IV infusion of balovaptan was administered after the final oral dose of balovaptan.