CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 16 enrolled
Drug / intervention
Balovaptan +1 moredrug
Likely dose
Rifampicin 600 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.

Search/NCT03586726
NCT03586726Phase 1Completed
CompareCT.gov

A Single-Center, Non-Randomized, Open-Label, One-Sequence, Two-Period Within-Subject Study to Investigate the Effect of Rifampicin on the Pharmacokinetics of Multiple Doses of Balovaptin In Healthy Volunteers

Hoffmann-La Roche·interventional·Posted Jul 16, 2018·Updated Nov 7, 2019

In Brief

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

Detailed Summary

This study was a single-center, non-randomized, open-label, one-sequence, two-period, within-subject study to investigate the effects of multiple doses of rifampicin on the PK and safety of multiple doses of balovaptan in healthy subjects. 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 PostedJul 16, 2018
Enrollment StartJul 24, 2018
Primary CompletionNov 2, 2018
Study CompletionNov 15, 2018
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 8.0 years ago

Interventions

Balovaptandrug

In Period 1, balovaptan was administered alone as a once daily (qd) dose on Days 1 to 10. In Period 2, balovaptan was administered as a qd dose on Days 7 to 16.

Rifampicindrug

In Period 2, 600 mg of rifampicin will be administered alone as a qd dose from Day 1 to Day 6, and as a qd dose on Days 7 to 16.