Healthy ParticipantsPhase 1NCT07860736
A Food Effect Study of Pitolisant Delayed-Release in Healthy Adult Participants
A Phase 1 study testing Pitolisant delayed-release in people with Healthy Participants, run by Harmony Biosciences Management, Inc. at 1 site in United States.
Trial summary
This is an open label, randomized, 2-way crossover study to assess the effect of a low-fat meal on the pharmacokinetics of pitolisant delayed-release in healthy adult participants. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- Pitolisant delayed-release
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jun 2026to 12 Jul 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Is able to provide voluntary, written informed consent.
- Continuous nonsmoker who has not used nicotine- or tobacco-containing products for at least 3 months prior to the first dosing.
Who cannot join
- Is mentally or legally incapacitated or has significant emotional problems at the time of the Screening visit or expected during the conduct of the study.
- History or presence of clinically significant medical or psychiatric condition or disease, including depression, bipolar disease, or psychosis, in the opinion of the PI or designee.
- Has acute or chronic liver disease or a history of moderate hepatic impairment (Child-Pugh Class B) or severe hepatic impairment (Child-Pugh Class C).
- Additional inclusion/exclusion criteria may apply, per protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label, Randomized, 2-Way Crossover Study to Assess the Effect of a Low-Fat Meal on the Bioavailability of Pitolisant Delayed-Release Tablets in Healthy Adult Participants
This is an open label, randomized, 2-way crossover study to assess the effect of a low-fat meal on the pharmacokinetics of pitolisant delayed-release in healthy adult participants.
- Conditions
- Healthy Participants
- Being tested
- Pitolisant delayed-release
- Keywords
- Food Effect Study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pitolisant delayed-releaseDrug
Also called HBS-201
Delayed-release tablets
| Study group | Role | What they receive |
|---|---|---|
| Pitolisant Delayed-release: Fasted then Fed | Experimental | Participants will receive 35.6 milligrams (mg) pitolisant delayed-release under fasted conditions. After a washout period of at least 10 days, participants will then receive 35.6 mg pitolisant delayed-release following a low-fat meal. Receives: Drug: Pitolisant delayed-release |
| Pitolisant Delayed-release: Fed then Fasted | Experimental | Participants will receive 35.6 mg pitolisant delayed-release following a low-fat meal. After a washout period of at least 10 days participants will then receive 35.6 mg pitolisant delayed-release under fasted conditions. Receives: Drug: Pitolisant delayed-release |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under The Concentration-time Curve, From Time 0 To The Last Observed Non Zero Concentration (AUClast)
Measured: Pre dose and up to 72 hours post dose
Secondary outcomes (1)
Number of Participants with Treatment Emergent Adverse Events
Measured: Up to 3.5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2026
- Study start18 Jun 2026
- Primary completion28 Jun 2026
- Study completion12 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harmony Biosciences Management, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Faulkner, PhD, Study director, Harmony Biosciences Management, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07860736
- Sponsor's protocol ID
- HBS-201-CL-103
- Status last verified
- Sep 2026
- First submitted
- 30 Sep 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Randomized, 2-Way Crossover Study to Assess the Effect of a Low-Fat Meal on the Bioavailability of Pitolisant Delayed-Release Tablets in Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT07860736
- Acronym / sponsor ID
- HBS-201-CL-103
- Conditions
- Healthy Participants
- Keywords
- Food Effect Study
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Harmony Biosciences Management, Inc.Industry (pharma, biotech, devices)
- Study start
- 18 Jun 2026 (actual)
- Primary completion
- 28 Jun 2026 (actual)
- Study completion
- 12 Jul 2026 (actual)
- First posted
- 6 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open label, randomized, 2-way crossover study to assess the effect of a low-fat meal on the pharmacokinetics of pitolisant delayed-release in healthy adult participants.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pitolisant Delayed-release: Fasted then Fed | Experimental | Drug: Pitolisant delayed-releaseParticipants will receive 35.6 milligrams (mg) pitolisant delayed-release under fasted conditions. After a washout period of at least 10 days, participants will then receive 35.6 mg pitolisant delayed-release following a low-fat meal. |
| Pitolisant Delayed-release: Fed then Fasted | Experimental | Drug: Pitolisant delayed-releaseParticipants will receive 35.6 mg pitolisant delayed-release following a low-fat meal. After a washout period of at least 10 days participants will then receive 35.6 mg pitolisant delayed-release under fasted conditions. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Is able to provide voluntary, written informed consent.
- Continuous nonsmoker who has not used nicotine- or tobacco-containing products for at least 3 months prior to the first dosing.
Key exclusion criteria (4 listed)
- Is mentally or legally incapacitated or has significant emotional problems at the time of the Screening visit or expected during the conduct of the study.
- History or presence of clinically significant medical or psychiatric condition or disease, including depression, bipolar disease, or psychosis, in the opinion of the PI or designee.
- Has acute or chronic liver disease or a history of moderate hepatic impairment (Child-Pugh Class B) or severe hepatic impairment (Child-Pugh Class C).
- Additional inclusion/exclusion criteria may apply, per protocol.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pitolisant delayed-releaseAlso: HBS-201Delayed-release tablets | Drug | Pitolisant Delayed-release: Fasted then Fed, Pitolisant Delayed-release: Fed then Fasted |
Primary outcome
Area Under The Concentration-time Curve, From Time 0 To The Last Observed Non Zero Concentration (AUClast)
Time frame: Pre dose and up to 72 hours post dose
1 secondary outcome
Number of Participants with Treatment Emergent Adverse Events
Time frame: Up to 3.5 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Faulkner, PhD study director
Harmony Biosciences Management, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Pitolisant delayed-release in people with Healthy Participants, run by Harmony Biosciences Management, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area Under The Concentration-time Curve, From Time 0 To The Last Observed Non Zero Concentration (AUClast) (time frame: Pre dose and up to 72 hours post dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.