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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
46
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).
Harmony Site 9
San Ramon, California, United States
Harmony Site 14
Brandon, Florida, United States
Harmony Site 4
Miami, Florida, United States
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.
Time frame: 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.
Time frame: 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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Harmony Site 8
Atlanta, Georgia, United States
Harmony Site 13
Newton, Massachusetts, United States
Harmony Site 11
Troy, Michigan, United States
Harmony Site 10
Denver, North Carolina, United States
Harmony Site 2
Huntersville, North Carolina, United States
Harmony Site 6
Canton, Ohio, United States
Harmony Site 1
Cincinnati, Ohio, United States
...and 5 more locations