Centre for Human Drug Research
Leiden, Netherlands
NCT Number: NCT03101189
So far, ACT-541468 has been studied mainly in Caucasian subjects. The present study will bridge results obtained in Caucasian subjects to those in Japanese subjects.
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Notify Me20 year–50 year
All sexes
Interventional
Phase 1
Leiden, Netherlands
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Key Inclusion Criteria:
Japanese subjects only:
Key Exclusion Criteria:
Capsule
Matching placebo capsule
Time frame: From Day1 pre-dose to 48 hours after the last dose on Day 5
The geometric mean Cmax values will be calculated based on pharmacokinetic (PK) blood sampling
Time frame: From Day1 pre-dose to 48 hours after the last dose on Day 5
The geometric mean AUC(0-24) values will be calculated based on PK blood sampling
Time frame: From Day1 pre-dose to 48 hours after the last dose on Day 5
The median tmax values will be calculated based on PK blood sampling
Time frame: From Day1 pre-dose to 48 hours after the last dose on Day 5
The geometric mean t(1/2) values will be calculated based on PK blood sampling
Time frame: From Day1 pre-dose to 48 hours after the last dose on Day 5
The geometric mean AUC(0-8) values will be calculated based on PK blood sampling
Time frame: Up to Day 7 (end of study)
The percentage of subjects with treatment-emergent adverse events will be reported
Time frame: Up to Day 5
The number of subjects who prematurely discontinued the study treatment due to an adverse event will be reported
Time frame: Up to Day 7 (end of study)
The number of subjects with any treatment-emergent electrocardiogram (ECG) abnormalities will be reported
Idorsia Pharmaceuticals Ltd.
Industry
A Single-center, Double-blind, Placebo-controlled, Randomized Study to Investigate the Tolerability, Safety, Pharmacokinetics, and Pharmacodynamics of Single- and Multiple-dose ACT-541468 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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