At a glance

ClinicalIndex Comparison Record

Phase 1Completed· 15 enrolled

Drug / intervention

Balovaptan +1 moredrug

Likely dose

Itraconazole 200 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/NCT03579719

NCT03579719Phase 1Completed

Compare CT.gov

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

Hoffmann-La Roche·interventional·Posted Jul 9, 2018·Updated Nov 4, 2019

In Brief

A Phase 1 clinical trial evaluating Balovaptan and Itraconazole for Healthy Volunteers. Completed, enrolled 15 participants across 1 site.

Detailed Summary

This study was a non-randomized, open-label, one-sequence, two-period within-subject study to investigate the effect of CYP3A inhibition on the PK of balovaptan in healthy male and female volunteers using itraconazole as a CYP3A inhibitor. 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 2018

Enrollment StartJul 2018

Primary CompletionNov 2018

TodayJul 2026

First PostedJul 9, 2018

Enrollment StartJul 10, 2018

Primary CompletionNov 9, 2018

TodayJul 2, 2026

Enrollment to primary: 4 monthsPosted 8.0 years ago

Interventions

Balovaptandrug

In Period 1, balovaptan was administered orally once daily (qd) on Days 1 to 10. In Period 2, balovaptan was administered qd on Days 6 to 20.

Itraconazoledrug

In Period 2, 200 mg itraconzole was administered bid for 4 days and qd on Days 5-20, approximately 12 hours apart. On Days 6-20, 200 mg itraconazole was administered qd.