A Phase 1b, Open-Label Study of HBS-201 (Pitolisant Delayed-release) in Adult Participants With Narcolepsy
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 46
- Locations
- 15
- Primary Endpoint
- Percentage of participants who discontinue treatment due to a treatment-emergent adverse event (TEAE) related to study drug
Study Overview
Brief Summary
The purpose of this study is to assess the tolerability of HBS-201 when starting at a therapeutic dose in adult participants with narcolepsy.
Detailed Description
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •Has hypersomnolence due to another medical disorder.
- •Is currently taking or has taken WAKIX (pitolisant).
- •Has participated in an interventional research study involving another investigational medication, device, or behavioral treatment within 30 days or within 5 half-lives of the investigational medication prior to Screening.
- •Based on the judgment of the Investigator, is unsuitable for the study for any reason, including but not limited to unstable or uncontrolled medical conditions (including psychiatric and neurological conditions) or a medical condition that might interfere with the conduct of the study, confound interpretation of study results, pose a health risk to the participant, or compromise the integrity of the study.
Arms & Interventions
HBS-201
Participants will take HBS-201 orally once daily in the morning upon wakening, beginning the morning of Day 1 and continuing through Day 14.
Intervention: HBS-201 (Drug)
Outcomes
Primary Outcomes
Percentage of participants who discontinue treatment due to a treatment-emergent adverse event (TEAE) related to 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
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.
Frequency, severity, and seriousness of TEAEs
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
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.
Secondary Outcomes
No secondary outcomes reported