| Quviviq (daridorexant) / Idorsia, Syneos Health, Nxera Pharma, Simcere |
NCT02919319: A Single Ascending Dose Study of ACT-541468 in Healthy Male Subjects |
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| Completed | 1 | 40 | Europe | ACT-541468 (Formulation A), ACT-541468 (Formulation B), Placebo (Formulation A), Placebo (Formulation B), 14C-labeled ACT-541468, Placebo tracer | Idorsia Pharmaceuticals Ltd. | Healthy Subjects | 05/15 | 05/15 | | |
NCT02526888: Pharmacokinetic Interaction Between Diltiazem and ACT-541468 in Healthy Subjects |
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| Completed | 1 | 14 | Europe | ACT-541468, Diltiazem | Idorsia Pharmaceuticals Ltd. | Healthy Subjects | 11/15 | 11/15 | | |
NCT02571855: A Study to Investigate the Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of ACT-541468 in Healthy Young Adults and Elderly Subjects |
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| Completed | 1 | 85 | Europe | ACT-541468 (hydrochloride salt), ACT-541468 (free base), Placebo | Idorsia Pharmaceuticals Ltd. | Healthy Subjects | 02/16 | 02/16 | | |
NCT03017495: A Clinical Study to Investigate the Potential Interactions Between Food and ACT-541468 and Between ACT-541468 and Midazolam |
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| Completed | 1 | 20 | Europe | Midazolam, ACT-541468 | Idorsia Pharmaceuticals Ltd. | Healthy Subjects | 02/17 | 02/17 | | |
NCT03101189: A Study of ACT-541468 in Healthy Japanese and Caucasian Subjects |
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| Completed | 1 | 40 | Europe | ACT-541468, placebo | Idorsia Pharmaceuticals Ltd. | Healthy Subjects | 04/17 | 04/17 | | |
NCT03339752: 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 |
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| Completed | 1 | 20 | RoW | Rosuvastatin, ACT-541468 | Idorsia Pharmaceuticals Ltd. | Healthy Subjects | 12/17 | 12/17 | | |
NCT03609775: A Study to Investigate the Drug-drug Interactions Between ACT-541468 and Ethanol in Healthy Subjects |
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| Completed | 1 | 22 | Europe | ACT-541468, ACT-541468 placebo, Ethanol 10%, Ethanol placebo | Idorsia Pharmaceuticals Ltd. | Healthy | 10/18 | 10/18 | | |
NCT03799978: A Clinical Study to Investigate the Food Effect on the Pharmacokinetics of ACT-541468 in Healthy Male Subjects |
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| Completed | 1 | 20 | RoW | ACT-541468 | Idorsia Pharmaceuticals Ltd. | Healthy | 03/19 | 03/19 | | |
NCT03686995: Study to Evaluate the PK of ACT-541468 in Subjects With Mild, Moderate, and Severe Hepatic Impairment |
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| Not yet recruiting | 1 | 32 | Europe | ACT-541468 | University Hospital, Basel, Switzerland, Idorsia Pharmaceuticals Ltd. | Hepatic Impairment | 06/19 | 06/19 | | |
NCT03907215: A Clinical Study to Examine the Drug-drug Interactions Between ACT-541468 and Citalopram in Healthy Male and Female Subjects |
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| Completed | 1 | 24 | Europe | ACT541468, ACT541468 placebo, Citalopram | Idorsia Pharmaceuticals Ltd. | Healthy | 06/19 | 06/19 | | |
NCT03657355: Study to Evaluate the Abuse Potential of ACT-541468 in Healthy Recreational Drug Users |
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| Completed | 1 | 63 | Canada, US | ACT-541468, Suvorexant, Zolpidem, Placebo | Idorsia Pharmaceuticals Ltd. | Healthy Recreational Drug Users | 08/19 | 08/19 | | |
NCT03646864: A Study to Evaluate the Effects of ACT-541468 on Respiration in Patients With Moderate Chronic Obstructive Pulmonary Disease |
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| Completed | 1 | 28 | Europe | ACT-541468, Placebo | Idorsia Pharmaceuticals Ltd. | Chronic Obstructive Pulmonary Disease | 09/19 | 09/19 | | |
NCT03892902: A Clinical Study to Assess Next-day Driving Performance Following Administration of ACT-541468 in Middle-aged and Elderly Subjects |
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| Completed | 1 | 56 | Europe | ACT-541468, Zopiclone 7.5 mg, Placebo | Idorsia Pharmaceuticals Ltd. | Healthy | 10/19 | 10/19 | | |
NCT03765294: A Study to Investigate the Effects of ACT-541468 on Nighttime Respiratory Function in Patients With Mild to Moderate Obstructive Sleep Apnea |
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| Completed | 1 | 28 | Europe | ACT-541468, Placebo | Idorsia Pharmaceuticals Ltd. | Obstructive Sleep Apnea | 11/19 | 11/19 | | |
NCT03713242: A Study to Evaluate the Pharmacokinetics of ACT-541468 in Subjects With Mild, Moderate, and Severe Hepatic Impairment |
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| Completed | 1 | 32 | Europe | ACT-541468 25 mg, ACT-541468 25 mg (or 10 mg depending on interim results) | Idorsia Pharmaceuticals Ltd. | Hepatic Impairment | 02/20 | 02/20 | | |
NCT04390334: 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. |
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| Completed | 1 | 24 | Europe | Daridorexant, Famotidine, Efavirenz | Idorsia Pharmaceuticals Ltd. | Healthy | 06/20 | 06/20 | | |
NCT04250506: A Study to Assess the Effect of Single Doses of Daridorexant on Electrocardiogram Parameters in Healthy Subjects |
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| Completed | 1 | 36 | RoW | Daridorexant, Placebo, Moxifloxacin | Idorsia Pharmaceuticals Ltd. | Healthy | 07/20 | 07/20 | | |
NCT04024332: 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 |
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| Completed | 1 | 16 | Europe | ACT-541468 | Idorsia Pharmaceuticals Ltd. | Renal Insufficiency, Healthy | 08/20 | 08/20 | | |
NCT05480475: 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 |
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| Completed | 1 | 24 | RoW | Dabigatran etexilate, Rosuvastatin, Daridorexant | Idorsia Pharmaceuticals Ltd. | Healthy | 09/22 | 09/22 | | |
NCT05480488: 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 |
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| Completed | 1 | 18 | Europe | Midazolam, Warfarin, Daridorexant | Idorsia Pharmaceuticals Ltd. | Healthy | 09/22 | 10/22 | | |
NCT05458193: A Study to Investigate the Effects of Daridorexant on Nighttime Breathing in Patients With Shallow or Paused Breath During Sleep |
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| Completed | 1 | 20 | Europe | Daridorexant, ACT-541468, Placebo | Idorsia Pharmaceuticals Ltd. | Obstructive Sleep Apnea of Adult | 02/23 | 02/23 | | |
NCT05702177: 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 |
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| Completed | 1 | 36 | Europe | Daridorexant 25 mg, Quviviq, Daridorexant 50 mg, Placebo | Idorsia Pharmaceuticals Ltd. | Healthy | 04/23 | 04/23 | | |
NCT05632393: A Study to Measure Daridorexant in Breast Milk of Healthy Lactating Women |
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| Completed | 1 | 10 | US | Daridorexant | Idorsia Pharmaceuticals Ltd. | Healthy | 04/23 | 04/23 | | |
NCT05877222: 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 |
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| Completed | 1 | 38 | US | Daridorexant 10 mg, Daridorexant 25 mg | Idorsia Pharmaceuticals Ltd. | Healthy | 08/23 | 08/23 | | |
NCT06326723: Investigate the PK, Safety, and Tolerability After Single and Multiple Dose Daridorexant in Chinese Healthy Subjects |
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| Completed | 1 | 32 | RoW | Daridorexant | Jiangsu Simcere Pharmaceutical Co., Ltd. | Healthy Volunteer | 12/23 | 02/24 | | |
