CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 57 enrolled
Drug / intervention
Balovaptan therapeutic dose Treatment A +11 moredrug
Likely dose
Active control [moxifloxacin] on Day 2 Treatment C 400 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/NCT03808298
NCT03808298Phase 1Completed
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A Single-Center, Multiple-Dose, Randomized, Double-Blind, Placebo-Controlled, Cross-Over Study to Investigate the Effect of Balovaptan on the QTC Interval in Healthy Subjects

Hoffmann-La Roche·interventional·Posted Jan 17, 2019·Updated Jul 24, 2020

In Brief

A Phase 1 clinical trial evaluating Balovaptan therapeutic dose Treatment A, Balovaptan supra-therapeutic dose Treatment B, and 10 other interventions for Healthy Volunteers. Completed, enrolled 57 participants across 1 site.

Detailed Summary

This was a single-center, multiple-dose, randomized, double-blind, placebo-controlled, positive-controlled, twelve sequence, 3-period cross-over study to investigate the effect of balovaptan on the QTc interval in healthy subjects.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Volunteers
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
20192020202120222023202420252026
First PostedJan 17, 2019
Enrollment StartFeb 7, 2019
Primary CompletionJun 14, 2019
Study CompletionJul 13, 2019
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 7.5 years ago

Interventions

Balovaptan therapeutic dose Treatment Adrug

Days 1-14: A single once daily dose at dose level A of balovaptan for 14 days

Balovaptan supra-therapeutic dose Treatment Bdrug

Days 1-14: A single once daily oral dose at dose level B of balovaptan for 14 days.

Active control [moxifloxacin] on Day 2 Treatment Cdrug

Day 2: A single oral dose of 400 mg moxifloxacin capsule.

Active control [Moxifloxacin] on Day 15 Treatment Ddrug

Day 15: A single oral dose of 400 mg moxifloxacin capsule.

Placebo for Balovaptan Treatment Cdrug

Days 1-14: Matching placebo for balovaptan for 14 days.

Placebo for Balovaptan Treatment Ddrug

Days 1-14: Matching placebo for balovaptan for 14 days.

Placebo for Moxifloxacin Treatment Adrug

Day 2 and 15: A single oral dose of a matching placebo capsule for moxifloxacin.

Placebo for Moxifloxacin Treatment Bdrug

Days 2 and 15: Single oral dose of a matching placebo capsule of moxifloxacin.

Moxifloxacin Treatment Cdrug

Day 2: A single oral dose of 400 mg moxifloxacin capsule.

Placebo for Moxifloxacin Treatment Cdrug

Day 15: A single oral dose of a matching placebo capsule for moxifloxacin.

Placebo for Moxifloxacin Treatment Ddrug

Day 2: A single oral dose of a matching placebo capsule for moxifloxacin.

Moxifloxacin Treatment Ddrug

Day 15: A single oral dose of 400 mg moxifloxacin capsule.