Healthy ParticipantsPhase 1NCT07487740
A Food Effect Study to Evaluate the Relative Bioavailability of Nalbuphine Extended-Release Tablets (NAL ER) in Healthy Participants
A Phase 1 study testing NAL ER in people with Healthy Participants, run by Trevi Therapeutics at 1 site in United States.
Trial summary
The primary purpose of this study is to evaluate the effect of a high-fat, high-calorie meal on the relative bioavailability of NAL ER following single oral doses. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- NAL ER
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Feb 2026to 19 May 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body mass index (BMI) ≥ 18.0 and ≤ 30.0 kilogram per meter square (kg/m2) at Screening.
- Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs or electrocardiograms (ECGs), as deemed by the principal investigator (PI) or designee.
Who cannot join
- Positive results for coronavirus infection (COVID-19) at Screening or check-in (Day -1).
- History or presence of alcohol or drug abuse within the past 2 years prior to the first dosing.
- Positive urine drug or alcohol results at Screening or check in (Day -1).
- Smoker who has smoked or used nicotine containing products within the last 3 months prior to the first dose and throughout the study, confirmed by a negative cotinine test at Screening and check-in (Day -1).
- History or presence of hypersensitivity or idiosyncratic reaction to the study drugs or related compounds.
- Hemoglobin, absolute neutrophil count, or platelet levels outside of the reference range at Screening.
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- History of prolonged QT syndrome or a corrected QT (QTc) interval.
- Positive results at Screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV).
- Participation in another clinical study within 5 half-lives or 30 days, whichever is longer, of the Baseline visit.
- Note: Other inclusion/exclusion criteria mentioned in the protocol may apply.
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical Pharmacology of Miami, LLC.
Miami, Florida, 33172
About this study
Official title: A Randomized, Phase 1, Open-Label, Two-Treatment, Two- Period, Two-Sequence, Single-Dose Crossover Study to Evaluate the Effect of Food on the Relative Bioavailability of Nalbuphine Extended-Release Tablets (NAL ER) in Healthy Subjects
The primary purpose of this study is to evaluate the effect of a high-fat, high-calorie meal on the relative bioavailability of NAL ER following single oral doses.
- Conditions
- Healthy Participants
- Being tested
- NAL ER
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NAL ERDrug
Also called Nalbuphine
Oral tablets
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: NAL ER Dose A | Experimental | Participants will receive NAL ER Dose A on Day 1 in the fasted state, followed by dosing on Day 5 in the fed state in the first sequence, and vice versa in the second sequence, with a 3-day washout maintained between sequences. Receives: Drug: NAL ER |
| Cohort 2: NAL ER Dose B | Experimental | Participants will receive NAL ER Dose B on Day 1 in the fasted state, followed by dosing on Day 5 in the fed state in the first sequence, and vice versa in the second sequence, with a 3-day washout maintained between sequences. Receives: Drug: NAL ER |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative Bioavailability of NAL ER
Measured: Predose and at multiple timepoints postdose (from Day 1 to Day 8)
Secondary outcomes (7)
Maximum Plasma Concentration (Cmax) of NAL ER
Measured: Predose and at multiple timepoints postdose (from Day 1 to Day 8)
Time to Reach Maximum Observed Concentration (Tmax) of NAL ER
Measured: Predose and at multiple timepoints postdose (from Day 1 to Day 8)
Area Under the Concentration-Time Curve From Time Zero to Time of Last Measurable Concentration (AUC0-Tlast) of NAL ER
Measured: Predose and at multiple timepoints postdose (from Day 1 to Day 8)
Area Under the Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of NAL ER
Measured: Predose and at multiple timepoints postdose (from Day 1 to Day 8)
Apparent Terminal Rate Constant (λz) of NAL ER
Measured: Predose and at multiple timepoints postdose (from Day 1 to Day 8)
Apparent Terminal Half-Life (t1/2) of NAL ER
Measured: Predose and at multiple timepoints postdose (from Day 1 to Day 8)
Safety and Tolerability as Assessed by Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Measured: Up to Day 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2026
- Study start27 Feb 2026
- Primary completion11 May 2026
- Study completion19 May 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trevi Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chief Development Officer, Study director, Trevi Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07487740
- Sponsor's protocol ID
- NAL00-107
- Status last verified
- Aug 2026
- First submitted
- 17 Mar 2026
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Phase 1, Open-Label, Two-Treatment, Two- Period, Two-Sequence, Single-Dose Crossover Study to Evaluate the Effect of Food on the Relative Bioavailability of Nalbuphine Extended-Release Tablets (NAL ER) in Healthy Subjects
- ClinicalTrials.gov ID
- NCT07487740
- Acronym / sponsor ID
- NAL00-107
- Conditions
- Healthy Participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Trevi TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 27 Feb 2026 (actual)
- Primary completion
- 11 May 2026 (actual)
- Study completion
- 19 May 2026 (actual)
- First posted
- 23 Mar 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.
The primary purpose of this study is to evaluate the effect of a high-fat, high-calorie meal on the relative bioavailability of NAL ER following single oral doses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: NAL ER Dose A | Experimental | Drug: NAL ERParticipants will receive NAL ER Dose A on Day 1 in the fasted state, followed by dosing on Day 5 in the fed state in the first sequence, and vice versa in the second sequence, with a 3-day washout maintained between sequences. |
| Cohort 2: NAL ER Dose B | Experimental | Drug: NAL ERParticipants will receive NAL ER Dose B on Day 1 in the fasted state, followed by dosing on Day 5 in the fed state in the first sequence, and vice versa in the second sequence, with a 3-day washout maintained between sequences. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Body mass index (BMI) ≥ 18.0 and ≤ 30.0 kilogram per meter square (kg/m2) at Screening.
- Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs or electrocardiograms (ECGs), as deemed by the principal investigator (PI) or designee.
Key exclusion criteria (10 listed)
- Positive results for coronavirus infection (COVID-19) at Screening or check-in (Day -1).
- History or presence of alcohol or drug abuse within the past 2 years prior to the first dosing.
- Positive urine drug or alcohol results at Screening or check in (Day -1).
- Smoker who has smoked or used nicotine containing products within the last 3 months prior to the first dose and throughout the study, confirmed by a negative cotinine test at Screening and check-in (Day -1).
- History or presence of hypersensitivity or idiosyncratic reaction to the study drugs or related compounds.
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 |
|---|---|---|
| NAL ERAlso: NalbuphineOral tablets | Drug | Cohort 1: NAL ER Dose A, Cohort 2: NAL ER Dose B |
Primary outcome
Relative Bioavailability of NAL ER
Time frame: Predose and at multiple timepoints postdose (from Day 1 to Day 8)
7 secondary outcomes
Maximum Plasma Concentration (Cmax) of NAL ER
Time frame: Predose and at multiple timepoints postdose (from Day 1 to Day 8)
Time to Reach Maximum Observed Concentration (Tmax) of NAL ER
Time frame: Predose and at multiple timepoints postdose (from Day 1 to Day 8)
Area Under the Concentration-Time Curve From Time Zero to Time of Last Measurable Concentration (AUC0-Tlast) of NAL ER
Time frame: Predose and at multiple timepoints postdose (from Day 1 to Day 8)
Area Under the Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of NAL ER
Time frame: Predose and at multiple timepoints postdose (from Day 1 to Day 8)
Apparent Terminal Rate Constant (λz) of NAL ER
Time frame: Predose and at multiple timepoints postdose (from Day 1 to Day 8)
Apparent Terminal Half-Life (t1/2) of NAL ER
Time frame: Predose and at multiple timepoints postdose (from Day 1 to Day 8)
Safety and Tolerability as Assessed by Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Time frame: Up to Day 18
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 21 Aug 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.
Chief Development Officer study director
Trevi Therapeutics
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 NAL ER in people with Healthy Participants, run by Trevi Therapeutics 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 10 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 21 Aug 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?
Relative Bioavailability of NAL ER (time frame: Predose and at multiple timepoints postdose (from Day 1 to Day 8)). 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 21 Aug 2026.