Anaheim Clinical Trials
Anaheim, California, 92801, United States
NCT Number: NCT03586570
The objective of this study is to evaluate the tolerability, safety, and pharmacokinetics after multiple-dose administration of aprocitentan (25 mg) in healthy Japanese and Caucasian subjects.
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Notify Me20 year–45 year
All sexes
Interventional
Phase 1
Anaheim, California, 92801, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Negative serum pregnancy test at Screening,
Negative urine pregnancy test on Day -1,
Agreement to consistently and correctly use a reliable method of contraception from Screening up to at least 30 days after last study treatment administration
Japanese subjects only
Exclusion criteria
Oral tablets in strength of 25 mg
Oral tablets matching aprocitentan tablets
Time frame: From study treatment administration to 216 hours after last administration
Time frame: From study treatment administration to 216 hours after last administration
Time frame: From study treatment administration to 216 hours after last administration
Idorsia Pharmaceuticals Ltd.
Industry
A Single-center, Double-blind, Placebo-controlled, Randomized Study to Investigate the Tolerability, Safety, and Pharmacokinetics After Multiple-dose Administration of 25 mg Aprocitentan in Healthy Japanese and Caucasian 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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