NCT04281342

To Study the Effect of Aprocitentan on the Electrical Activity of the Heart in Healthy Men and Women

Prospective, Single-center, Randomized, Double-blind, Placebo- and Moxifloxacin-controlled, 4-way Crossover Phase 1 Study to Assess the Effect of Multiple Therapeutic and Supratherapeutic Doses of Aprocitentan on the QT Interval Duration in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Idorsia Pharmaceuticals Ltd. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

To demonstrate that multiple-dose administration of oral therapeutic and supratherapeutic doses of aprocitentan do not have a clinically relevant effect on the QT interval.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	Aprocitentan 25 mg	Repeated administration of a 25 mg oral dose of aprocitentan, once daily from Day 1 to Day 10, followed by 18 days of observation.
DRUG	Aprocitentan 100 mg	Repeated administration of a 100 mg oral dose of aprocitentan, once daily from Day 1 to Day 10, followed by 18 days of observation.
DRUG	Matching placebo	Repeated administration of an oral dose of aprocitentan-matching placebo, once daily from Day 1 to Day 10, followed by 18 days of observation.
OTHER	Moxifloxacin control to establish assay sensitivity	Repeated administration of an oral dose of aprocitentan-matching placebo, once daily from Day 1 to Day 9. On Day 10, oral administration of one single 400 mg moxifloxacin tablet open-label, followed by 18 days of observation.

Timeline

• Start date: 2020-01-14
• Primary completion: 2021-08-03
• Completion: 2021-09-03
• First posted: 2020-02-24
• Last updated: 2022-11-23

Locations

1 site across 1 country: Germany