CRS Clinical Research Services Mannheim GmbH
Mannheim, Baden-Wurttemberg, 68167, Germany
NCT Number: NCT04281342
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.
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Notify Me18 year–55 year
All sexes
Interventional
Phase 1
Mannheim, Baden-Wurttemberg, 68167, Germany
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Repeated administration of a 25 mg oral dose of aprocitentan, once daily from Day 1 to Day 10, followed by 18 days of observation.
Other names: ACT-132577
Repeated administration of a 100 mg oral dose of aprocitentan, once daily from Day 1 to Day 10, followed by 18 days of observation.
Other names: ACT-132577
Repeated administration of an oral dose of aprocitentan-matching placebo, once daily from Day 1 to Day 10, followed by 18 days of observation.
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.
Time frame: Multiple predefined time points related to study treatment administration on Day 1 and Day 10 to 11 of each treatment.
Time frame: Day 2 to Day 9
Time frame: Pre-defined times on the first dosing day (Day 1) up to 15 hours after last dose
Time frame: Pre-defined times on the last dosing day (Day 10) up to 15 hours after last dose
Time frame: Day 1 to Day 10
Time frame: Day 1 to Day 10
Time frame: Day 1; Day 10
Idorsia Pharmaceuticals Ltd.
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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