NCT04281342 - To Study the Effect of Aprocitentan on the Electrical Activity of the Heart in Healthy Men and Women | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

January 14, 2020

Primary Completion Date

August 3, 2021

Study Completion Date

September 3, 2021

Conditions

Healthy Subjects

Interventions

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.

Trial Locations (1)

68167

CRS Clinical Research Services Mannheim GmbH, Mannheim