24 completed. 24 Phase 1.
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All 24 trials
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| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
Investigate the PK, Safety, and Tolerability After Single and Multiple Dose Daridorexant in Chinese Healthy Subjects Daridorexant - Healthy Volunteer | Phase 1 | Completed | 32 | 2023-09-04 | 2024-03-22 |
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 1 | Completed | 38 | 2023-06-23 | 2023-08-16 |
A Study to Measure Daridorexant in Breast Milk of Healthy Lactating Women Daridorexant - Healthy | Phase 1 | Completed | 10 | 2023-01-16 | 2023-05-12 |
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 1 | Completed | 36 | 2023-01-05 | 2023-05-12 |
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 1 | Completed | 24 | 2022-09-03 | 2022-11-08 |
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 1 | Completed | 18 | 2022-08-23 | 2022-11-08 |
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 1 | Completed | 20 | 2022-08-17 | 2023-04-04 |
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 1 | Completed | 24 | 2020-05-13 | 2020-09-16 |
A Study to Assess the Effect of Single Doses of Daridorexant on Electrocardiogram Parameters in Healthy Subjects Daridorexant, Placebo, Moxifloxacin - Healthy | Phase 1 | Completed | 36 | 2020-02-28 | 2020-09-16 |
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 1 | Completed | 16 | 2019-09-24 | 2020-09-03 |
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 1 | Completed | 24 | 2019-04-09 | 2019-10-31 |
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 1 | Completed | 56 | 2019-03-25 | 2019-10-31 |
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 1 | Completed | 28 | 2019-03-14 | 2019-12-19 |
A Clinical Study to Investigate the Food Effect on the Pharmacokinetics of ACT-541468 in Healthy Male Subjects ACT-541468 - Healthy | Phase 1 | Completed | 20 | 2019-03-09 | 2019-04-12 |
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 1 | Completed | 28 | 2018-11-15 | 2019-09-23 |
Study to Evaluate the Abuse Potential of ACT-541468 in Healthy Recreational Drug Users ACT-541468, Suvorexant, Zolpidem - Healthy Recreational Drug Users | Phase 1 | Completed | 63 | 2018-09-07 | 2019-09-19 |
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 1 | Completed | 22 | 2018-08-28 | 2018-10-15 |
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 1 | Completed | 32 | 2018-02-26 | 2020-07-02 |
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 1 | Completed | 20 | 2017-10-30 | 2017-12-11 |
A Study of ACT-541468 in Healthy Japanese and Caucasian Subjects ACT-541468, placebo - Healthy Subjects | Phase 1 | Completed | 40 | 2017-03-15 | 2018-07-10 |
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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)