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The purpose of this study is to assess the tolerability of HBS-201 when starting at a therapeutic dose in adult participants with narcolepsy.
This is a Phase 1b, open-label, multicenter study to assess the tolerability of HBS-201 when starting at a therapeutic dose in adult participants with narcolepsy. Therapeutic dose range is defined as 17.8 milligram (mg) to 35.6 mg based on the FDA-approved prescribing information for WAKIX.
The study will consist of an up to 30-day Screening/Baseline Period, a 2-week Open-Label Period, and a 30-day Safety Follow-up Period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HBS-201 | Experimental | Participants will take HBS-201 orally once daily in the morning upon wakening, beginning the morning of Day 1 and continuing through Day 14. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HBS-201 | Drug | On Days 1-7, participants will take HBS-201 17.8 mg per day (one 17.8 mg tablet) and on Days 8-14, participants will take HBS-201 35.6 mg per day (two 17.8 mg tablets). |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants who discontinue treatment due to a treatment-emergent adverse event (TEAE) related to study drug | A TEAE is any adverse event (AE) reported after the first dose of study drug, or any worsening of a pre-existing condition reported after first dose of study drug. | From administration of the first dose of study drug (Day 1) through 30 days after the final dose of study drug, approximately 44 days |
| Frequency, severity, and seriousness of TEAEs | A TEAE is any adverse event (AE) reported after the first dose of study drug, or any worsening of a pre-existing condition reported after first dose of study drug. | From administration of the first dose of study drug (Day 1) through 30 days after the final dose of study drug, approximately 44 days |
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Inclusion Criteria:
1. Has a current documented diagnosis of narcolepsy type 1 or narcolepsy type 2 per International Classification of Sleep Disorders, 3rd Edition (ICSD-3) criteria.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Harmony Site 9 | San Ramon | California | 94583 | United States | ||
| Harmony Site 14 |
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|
| Brandon |
| Florida |
| 33511 |
| United States |
| Harmony Site 4 | Miami | Florida | 33176 | United States |
| Harmony Site 8 | Atlanta | Georgia | 30328 | United States |
| Harmony Site 13 | Newton | Massachusetts | 02459 | United States |
| Harmony Site 11 | Troy | Michigan | 48085 | United States |
| Harmony Site 10 | Denver | North Carolina | 28037 | United States |
| Harmony Site 2 | Huntersville | North Carolina | 28078 | United States |
| Harmony Site 6 | Canton | Ohio | 44718 | United States |
| Harmony Site 1 | Cincinnati | Ohio | 45245 | United States |
| Harmony Site 15 | Wyomissing | Pennsylvania | 19610 | United States |
| Harmony Site 5 | Columbia | South Carolina | 29201 | United States |
| Harmony Site 12 | North Charleston | South Carolina | 29406 | United States |
| Harmony Site 3 | Austin | Texas | 78731 | United States |
| Harmony Site 7 | Morgantown | West Virginia | 26506 | United States |
| ID | Term |
|---|---|
| D009290 | Narcolepsy |
| ID | Term |
|---|---|
| D006970 | Disorders of Excessive Somnolence |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
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