NCT05933447

Thorough QT Study to Evaluate the Effect of Rodatristat Ethyl, Rodatristat and Its Major Metabolites on the Heart

A Randomized, Double-Blind and Nested Crossover (For Placebo and Moxifloxacin) Thorough QT Study to Evaluate the Effect of Rodatristat Ethyl, Rodatristat, and Its Major Metabolites on Cardiac Repolarization in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Altavant Sciences GmbH · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

To evaluate whether Rodatristat Ethyl prolongs the QTc interval when orally administered to healthy volunteers.

Detailed description

This is a Phase I, single-center, double blind, randomized, placebo- and positive-control, nested crossover study in approximately 64 healthy volunteers. This thorough QT/QTc study will be conducted to evaluate the effect of Rodatristat Ethyl on QT prolongation.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Rodatristat Ethyl	Oral, Tablet, 300 mg QD, 300 mg BID, 600 mg BID, 900 mg BID, 900 mg QD
DRUG	Moxifloxacin	Oral, Tablet, 400 mg QD
DRUG	Placebo for Rodatristat	Oral, Tablet, O mg QD, 0 mg BID
DRUG	Placebo for Moxifloxacin	Oral, Tablet, 0 mg QD

Timeline

• Start date: 2023-05-12
• Primary completion: 2023-07-28
• Completion: 2023-07-28
• First posted: 2023-07-06
• Last updated: 2023-10-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study