NCT03808298

Study to Investigate the Effect of Balovaptan on the QTC Interval in Healthy Subjects

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 57 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Balovaptan therapeutic dose Treatment A	Days 1-14: A single once daily dose at dose level A of balovaptan for 14 days
DRUG	Balovaptan supra-therapeutic dose Treatment B	Days 1-14: A single once daily oral dose at dose level B of balovaptan for 14 days.
DRUG	Active control [moxifloxacin] on Day 2 Treatment C	Day 2: A single oral dose of 400 mg moxifloxacin capsule.
DRUG	Active control [Moxifloxacin] on Day 15 Treatment D	Day 15: A single oral dose of 400 mg moxifloxacin capsule.
DRUG	Placebo for Balovaptan Treatment C	Days 1-14: Matching placebo for balovaptan for 14 days.
DRUG	Placebo for Balovaptan Treatment D	Days 1-14: Matching placebo for balovaptan for 14 days.
DRUG	Placebo for Moxifloxacin Treatment A	Day 2 and 15: A single oral dose of a matching placebo capsule for moxifloxacin.
DRUG	Placebo for Moxifloxacin Treatment B	Days 2 and 15: Single oral dose of a matching placebo capsule of moxifloxacin.
DRUG	Moxifloxacin Treatment C	Day 2: A single oral dose of 400 mg moxifloxacin capsule.
DRUG	Placebo for Moxifloxacin Treatment C	Day 15: A single oral dose of a matching placebo capsule for moxifloxacin.
DRUG	Placebo for Moxifloxacin Treatment D	Day 2: A single oral dose of a matching placebo capsule for moxifloxacin.
DRUG	Moxifloxacin Treatment D	Day 15: A single oral dose of 400 mg moxifloxacin capsule.

Timeline

• Start date: 2019-02-07
• Primary completion: 2019-06-14
• Completion: 2019-07-13
• First posted: 2019-01-17
• Last updated: 2020-07-24
• Results posted: 2020-07-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study