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Last Updated: June 3, 2024

CLINICAL TRIALS PROFILE FOR ACT-541468


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Clinical Trials for ACT-541468

Trial ID Title Status Sponsor Phase Summary
NCT02526888 ↗ Pharmacokinetic Interaction Between Diltiazem and ACT-541468 in Healthy Subjects Completed Actelion Phase 1 The main objective of this study is to investigate whether repeated administration of a cardiac medication (diltiazem) can affect the pharmacokinetics (i.e., amount and time of presence in the blood) of ACT-541468
NCT02526888 ↗ Pharmacokinetic Interaction Between Diltiazem and ACT-541468 in Healthy Subjects Completed Idorsia Pharmaceuticals Ltd. Phase 1 The main objective of this study is to investigate whether repeated administration of a cardiac medication (diltiazem) can affect the pharmacokinetics (i.e., amount and time of presence in the blood) of ACT-541468
NCT02571855 ↗ A Study to Investigate the Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of ACT-541468 in Healthy Young Adults and Elderly Subjects Completed Actelion Phase 1 The purpose of this study is to evaluate the tolerability, safety, pharmacokinetics (PK, or amount of drug over time in the body) and pharmacodynamics (PD, or effects on the body) of ACT-541468 following multiple ascending doses in healthy adults and following single ascending doses in healthy elderly subjects when administered in the morning. The safety, PK and PD of ACT-541468 will also be assessed after repeated evening administration of a selected dose in both healthy adults and elderly.
NCT02571855 ↗ A Study to Investigate the Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of ACT-541468 in Healthy Young Adults and Elderly Subjects Completed Idorsia Pharmaceuticals Ltd. Phase 1 The purpose of this study is to evaluate the tolerability, safety, pharmacokinetics (PK, or amount of drug over time in the body) and pharmacodynamics (PD, or effects on the body) of ACT-541468 following multiple ascending doses in healthy adults and following single ascending doses in healthy elderly subjects when administered in the morning. The safety, PK and PD of ACT-541468 will also be assessed after repeated evening administration of a selected dose in both healthy adults and elderly.
NCT02839200 ↗ Efficacy and Safety of ACT-541468 in Adult Subjects With Insomnia Disorder Completed Actelion Phase 2 This study evaluates the dose response of ACT-541468 on the change of WASO from baseline to Days 1 and 2, assessed by PSG.
NCT02839200 ↗ Efficacy and Safety of ACT-541468 in Adult Subjects With Insomnia Disorder Completed Idorsia Pharmaceuticals Ltd. Phase 2 This study evaluates the dose response of ACT-541468 on the change of WASO from baseline to Days 1 and 2, assessed by PSG.
NCT02841709 ↗ Efficacy and Safety of ACT-541468 in Elderly Subjects With Insomnia Disorder Completed Actelion Phase 2 This study evaluates the dose response of ACT-541468 on the change of wake after sleep onset (WASO) assessed by polysomnography (PSG) on the first 2 days of each treatment period.
>Trial ID >Title >Status >Phase >Summary

Clinical Trial Conditions for ACT-541468

Condition Name

Condition Name for
Intervention Trials
Healthy Subjects 6
Insomnia Disorder 5
Healthy 5
Hepatic Impairment 2
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Condition MeSH

Condition MeSH for
Intervention Trials
Sleep Initiation and Maintenance Disorders 5
Disease 3
Sleep Apnea Syndromes 2
Liver Diseases 2
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Clinical Trial Locations for ACT-541468

Trials by Country

Trials by Country for
Location Trials
United States 82
Germany 12
Netherlands 5
Canada 5
Switzerland 4
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Trials by US State

Trials by US State for
Location Trials
Florida 5
New York 5
Ohio 5
California 4
Nevada 4
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Clinical Trial Progress for ACT-541468

Clinical Trial Phase

Clinical Trial Phase for
Clinical Trial Phase Trials
Phase 3 3
Phase 2 2
Phase 1 17
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Clinical Trial Status

Clinical Trial Status for
Clinical Trial Phase Trials
Completed 21
Not yet recruiting 1
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Clinical Trial Sponsors for ACT-541468

Sponsor Name

Sponsor Name for
Sponsor Trials
Idorsia Pharmaceuticals Ltd. 23
Actelion 7
University Hospital, Basel, Switzerland 1
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Sponsor Type

Sponsor Type for
Sponsor Trials
Industry 30
Other 1
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