daridorexant: Clinical Trials

24 trials of daridorexant, newest first

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24 completed. 24 Phase 1.

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PhaseTrialsStatus
Phase 124Completed 24

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All 24 trials

Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.

TrialPhaseStatusSponsorEnrollmentStartUpdated
Investigate the PK, Safety, and Tolerability After Single and Multiple Dose Daridorexant in Chinese Healthy Subjects
Daridorexant - Healthy Volunteer
Phase 1CompletedJiangsu Simcere Pharmaceutical Co., Ltd.322023-09-042024-03-22
A Phase 1 Trial to Investigate the Biological Equivalence of 5 × 10 mg Tablets and 2 × 25 mg Tablets of Daridorexant in Healthy Male and Female Japanese Participants
Daridorexant 10 mg, Daridorexant 25 mg - Healthy
Phase 1CompletedIdorsia Pharmaceuticals Ltd.382023-06-232023-08-16
A Study to Measure Daridorexant in Breast Milk of Healthy Lactating Women
Daridorexant - Healthy
Phase 1CompletedIdorsia Pharmaceuticals Ltd.102023-01-162023-05-12
A Study of the Effect of Daridorexant on Nighttime Body Posture, the Noise Level Required to Wake up, and the Ability to Remember Words Previously Presented
Daridorexant 25 mg, Daridorexant 50 mg, Placebo - Healthy
Phase 1CompletedIdorsia Pharmaceuticals Ltd.362023-01-052023-05-12
A Study to Examine the Effect of Daridorexant on the Way the Body Absorbs, Distributes, and Gets Rid of Dabigatran and Rosuvastatin in Healthy Male Subjects
Dabigatran etexilate, Rosuvastatin, Daridorexant - Healthy
Phase 1CompletedIdorsia Pharmaceuticals Ltd.242022-09-032022-11-08
A Study to Examine the Effect of Daridorexant on the Way the Body Absorbs, Distributes, and Gets Rid of Midazolam and Warfarin in Healthy Male Subjects
Midazolam, Warfarin, Daridorexant - Healthy
Phase 1CompletedIdorsia Pharmaceuticals Ltd.182022-08-232022-11-08
A Study to Investigate the Effects of Daridorexant on Nighttime Breathing in Patients With Shallow or Paused Breath During Sleep
Daridorexant, Placebo - Obstructive Sleep Apnea of Adult
Phase 1CompletedIdorsia Pharmaceuticals Ltd.202022-08-172023-04-04
A Study in Healthy Male Subjects to Investigate the Effect of Famotidine and Efavirenz on the Way the Body Takes up, Distributes, and Gets Rid of Daridorexant.
Daridorexant, Famotidine, Efavirenz - Healthy
Phase 1CompletedIdorsia Pharmaceuticals Ltd.242020-05-132020-09-16
A Study to Assess the Effect of Single Doses of Daridorexant on Electrocardiogram Parameters in Healthy Subjects
Daridorexant, Placebo, Moxifloxacin - Healthy
Phase 1CompletedIdorsia Pharmaceuticals Ltd.362020-02-282020-09-16
Study of the Way the Body Takes up, Distributes, and Gets Rid of ACT-541468 in Subjects With Abnormal Kidney Function Compared to Healthy Subjects
ACT-541468 - Renal Insufficiency, Healthy
Phase 1CompletedIdorsia Pharmaceuticals Ltd.162019-09-242020-09-03
A Clinical Study to Examine the Drug-drug Interactions Between ACT-541468 and Citalopram in Healthy Male and Female Subjects
ACT541468, ACT541468 placebo, Citalopram - Healthy
Phase 1CompletedIdorsia Pharmaceuticals Ltd.242019-04-092019-10-31
A Clinical Study to Assess Next-day Driving Performance Following Administration of ACT-541468 in Middle-aged and Elderly Subjects
ACT-541468, Zopiclone 7.5 mg, Placebo - Healthy
Phase 1CompletedIdorsia Pharmaceuticals Ltd.562019-03-252019-10-31
A Study to Investigate the Effects of ACT-541468 on Nighttime Respiratory Function in Patients With Mild to Moderate Obstructive Sleep Apnea
ACT-541468, Placebo - Obstructive Sleep Apnea
Phase 1CompletedIdorsia Pharmaceuticals Ltd.282019-03-142019-12-19
A Clinical Study to Investigate the Food Effect on the Pharmacokinetics of ACT-541468 in Healthy Male Subjects
ACT-541468 - Healthy
Phase 1CompletedIdorsia Pharmaceuticals Ltd.202019-03-092019-04-12
A Study to Evaluate the Effects of ACT-541468 on Respiration in Patients With Moderate Chronic Obstructive Pulmonary Disease
ACT-541468, Placebo - Chronic Obstructive Pulmonary Disease
Phase 1CompletedIdorsia Pharmaceuticals Ltd.282018-11-152019-09-23
Study to Evaluate the Abuse Potential of ACT-541468 in Healthy Recreational Drug Users
ACT-541468, Suvorexant, Zolpidem - Healthy Recreational Drug Users
Phase 1CompletedIdorsia Pharmaceuticals Ltd.632018-09-072019-09-19
A Study to Investigate the Drug-drug Interactions Between ACT-541468 and Ethanol in Healthy Subjects
ACT-541468, ACT-541468 placebo, Ethanol 10% - Healthy
Phase 1CompletedIdorsia Pharmaceuticals Ltd.222018-08-282018-10-15
A Study to Evaluate the Pharmacokinetics of ACT-541468 in Subjects With Mild, Moderate, and Severe Hepatic Impairment
ACT-541468 25 mg, ACT-541468 25 mg (or 10 mg depending on interim results) - Hepatic Impairment
Phase 1CompletedIdorsia Pharmaceuticals Ltd.322018-02-262020-07-02
A Study in Healthy Male Subjects to Investigate Whether Administration of ACT-541468 Can Affect the Fate in the Body (Amount and Time of Presence in the Blood) of Rosuvastatin
Rosuvastatin, ACT-541468 - Healthy Subjects
Phase 1CompletedIdorsia Pharmaceuticals Ltd.202017-10-302017-12-11
A Study of ACT-541468 in Healthy Japanese and Caucasian Subjects
ACT-541468, placebo - Healthy Subjects
Phase 1CompletedIdorsia Pharmaceuticals Ltd.402017-03-152018-07-10

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Conditions studied

Pulmonary Disease, Chronic Obstructive (1)  ·  Renal Insufficiency (1)  ·  Sleep Apnea, Obstructive (1)  ·  Sleep Initiation and Maintenance Disorders (1)

Sponsors

Idorsia Pharmaceuticals Ltd. (23)  ·  Jiangsu Simcere Pharmaceutical Co., Ltd. (1)

Countries

Germany (9)  ·  Netherlands (6)  ·  Czechia (4)  ·  United States (3)  ·  Canada (1)  ·  China (1)  ·  Switzerland (1)

Top investigators

Clemens Muehlan (2)  ·  Marie-Laure Boof, PhD (2)  ·  Juan Li (1)  ·  Pascale Gasser (1)

Results publications

PMID 31642731, PMID 33205362, PMID 33305817, PMID 34002356, PMID 34331678, PMID 34480579, PMID 35306405, PMID 37858005, PMID 38472696, PMID 39641404, PMID 42171662

NIH funding

2018 (2), 2019 (2), 2014 (1), 2016 (1)