Healthy ParticipantsPhase 1NCT07015398
A Study of the Pharmacokinetic Interaction Between Pirfenidone, Nintedanib, and Nalbuphine Extended Release (NAL ER) in Healthy Participants
A Phase 1 study testing NAL ER, Pirfenidone and Nintedanib 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 steady-state NAL ER on the pharmacokinetics (PK) of pirfenidone or nintedanib and the effect of steady-state pirfenidone or nintedanib on the PK of NAL ER in healthy participants. 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, Pirfenidone and Nintedanib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jun 2025to 26 Sep 2025
- 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/m^2) 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).
- History or presence of alcohol or drug abuse.
- Positive urine drug or alcohol results.
- Smoker who has used nicotine containing products within the last 3 months.
- 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.
Show all 13Show fewer
- History of prolonged QT syndrome or a QTc interval.
- Abnormal liver function at Screening or historical or concurrent liver disease.
- Positive results for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV).
- Abnormal Estimated glomerular filtration rate (eGFR).
- History of difficulty donating blood or donation of blood or plasma within 56 days of Screening.
- Participation in another clinical study within 30 days 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
Miami, Florida, 33172
About this study
Official title: A Phase 1, Two-Part, Open-Label Drug-Drug Interaction Study to Evaluate the Steady State Pharmacokinetics and Safety Following Co-Administration of Nalbuphine Extended-Release Tablets (NAL ER), and Pirfenidone or Nintedanib in Healthy Adult Subjects
The primary purpose of this study is to evaluate the effect of steady-state NAL ER on the pharmacokinetics (PK) of pirfenidone or nintedanib and the effect of steady-state pirfenidone or nintedanib on the PK of NAL ER in healthy participants.
- Conditions
- Healthy Participants
- Being tested
- NAL ER, Pirfenidone, Nintedanib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NAL ERDrug
Also called Nalbuphine Extended Release
Oral tablets
PirfenidoneDrug
Also called ESBRIET®
Oral tablets
NintedanibDrug
Also called OFEV®
Oral capsules
| Study group | Role | What they receive |
|---|---|---|
| Cohort A1 - NAL ER + Pirfenidone | Experimental | Participants will receive NAL ER followed by NAL ER co-administered with pirfenidone. Receives: Drug: NAL ER; Drug: Pirfenidone |
| Cohort A2 - NAL ER + Nintedanib | Experimental | Participants will receive NAL ER followed by NAL ER co-administered with nintedanib. Receives: Drug: NAL ER; Drug: Nintedanib |
| Cohort B1 - Pirfenidone + NAL ER | Experimental | Participants will receive pirfenidone followed by pirfenidone co-administered with NAL ER. Receives: Drug: NAL ER; Drug: Pirfenidone |
| Cohort B2 - Nintedanib + NAL ER | Experimental | Participants will receive nintedanib followed by nintedanib co-administered with NAL ER. Receives: Drug: NAL ER; Drug: Nintedanib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Plasma Concentration (Cmax) of NAL ER, Pirfenidone, and Nintedanib
Measured: Pre-dose and at multiple timepoints post-dose on Days 1 and 6 for Cohorts A1 and B1; on Days 1 and 8 for Cohort A2; on Days 1 and 7 for Cohort B2
Time to Reach Maximum Observed Concentration (Tmax) of NAL ER, Pirfenidone, and Nintedanib
Measured: Pre-dose and at multiple timepoints post-dose on Days 1 and 6 for Cohorts A1 and B1; on Days 1 and 8 for Cohort A2; on Days 1 and 7 for Cohort B2
Area Under the Concentration-Time Curve From Time Zero to Time of Last Measurable Concentration (AUC0-Tlast) of NAL ER, Pirfenidone, and Nintedanib
Measured: Pre-dose and at multiple timepoints post-dose on Days 1 and 6 for Cohorts A1 and B1; on Days 1 and 8 for Cohort A2; on Days 1 and 7 for Cohort B2
Area Under the Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of NAL ER, Pirfenidone, and Nintedanib
Measured: Pre-dose and at multiple timepoints post-dose on Days 1 and 6 for Cohorts A1 and B1; on Days 1 and 8 for Cohort A2; on Days 1 and 7 for Cohort B2
Apparent Terminal Rate Constant (λz) of NAL ER, Pirfenidone, and Nintedanib
Measured: Pre-dose and at multiple timepoints post-dose on Days 1 and 6 for Cohorts A1 and B1; on Days 1 and 8 for Cohort A2; on Days 1 and 7 for Cohort B2
Apparent Terminal Half-Life (t1/2) of NAL ER, Pirfenidone, and Nintedanib
Measured: Pre-dose and at multiple timepoints post-dose on Days 1 and 6 for Cohorts A1 and B1; on Days 1 and 8 for Cohort A2; on Days 1 and 7 for Cohort B2
Apparent Clearance (CL/F) of NAL ER, Pirfenidone, and Nintedanib
Measured: Pre-dose and at multiple timepoints post-dose on Days 1 and 6 for Cohorts A1 and B1; on Days 1 and 8 for Cohort A2; on Days 1 and 7 for Cohort B2
Apparent Volume of Distribution (Vz/F) of NAL ER, Pirfenidone, and Nintedanib
Measured: Pre-dose and at multiple timepoints post-dose on Days 1 and 6 for Cohorts A1 and B1; on Days 1 and 8 for Cohort A2; on Days 1 and 7 for Cohort B2
Secondary outcomes (2)
Safety and Tolerability as Assessed by Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Measured: Up to Day 21
Number of Participants With Clinically Significant Abnormalities in Vital Signs
Measured: Up to Day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2025
- Study start30 Jun 2025
- Primary completion12 Sep 2025
- Study completion26 Sep 2025
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 132 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
- NCT07015398
- Sponsor's protocol ID
- NAL00-105
- Status last verified
- Oct 2025
- First submitted
- 3 Jun 2025
- Last updated
- 10 Oct 2025
- 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 10 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Two-Part, Open-Label Drug-Drug Interaction Study to Evaluate the Steady State Pharmacokinetics and Safety Following Co-Administration of Nalbuphine Extended-Release Tablets (NAL ER), and Pirfenidone or Nintedanib in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT07015398
- Acronym / sponsor ID
- NAL00-105
- Conditions
- Healthy Participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Trevi TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 30 Jun 2025 (actual)
- Primary completion
- 12 Sep 2025 (actual)
- Study completion
- 26 Sep 2025 (actual)
- First posted
- 11 Jun 2025 (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 steady-state NAL ER on the pharmacokinetics (PK) of pirfenidone or nintedanib and the effect of steady-state pirfenidone or nintedanib on the PK of NAL ER in healthy participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort A1 - NAL ER + Pirfenidone | Experimental | Drug: NAL ER, Drug: PirfenidoneParticipants will receive NAL ER followed by NAL ER co-administered with pirfenidone. |
| Cohort A2 - NAL ER + Nintedanib | Experimental | Drug: NAL ER, Drug: NintedanibParticipants will receive NAL ER followed by NAL ER co-administered with nintedanib. |
| Cohort B1 - Pirfenidone + NAL ER | Experimental | Drug: NAL ER, Drug: PirfenidoneParticipants will receive pirfenidone followed by pirfenidone co-administered with NAL ER. |
| Cohort B2 - Nintedanib + NAL ER | Experimental | Drug: NAL ER, Drug: NintedanibParticipants will receive nintedanib followed by nintedanib co-administered with NAL ER. |
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/m^2) 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 (13 listed)
- Positive results for coronavirus infection (COVID-19).
- History or presence of alcohol or drug abuse.
- Positive urine drug or alcohol results.
- Smoker who has used nicotine containing products within the last 3 months.
- 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: Nalbuphine Extended ReleaseOral tablets | Drug | Cohort A1 - NAL ER + Pirfenidone, Cohort A2 - NAL ER + Nintedanib, Cohort B1 - Pirfenidone + NAL ER, Cohort B2 - Nintedanib + NAL ER |
| PirfenidoneAlso: ESBRIET®Oral tablets | Drug | Cohort A1 - NAL ER + Pirfenidone, Cohort B1 - Pirfenidone + NAL ER |
| NintedanibAlso: OFEV®Oral capsules | Drug | Cohort A2 - NAL ER + Nintedanib, Cohort B2 - Nintedanib + NAL ER |
Primary outcome
Maximum Plasma Concentration (Cmax) of NAL ER, Pirfenidone, and Nintedanib
Time frame: Pre-dose and at multiple timepoints post-dose on Days 1 and 6 for Cohorts A1 and B1; on Days 1 and 8 for Cohort A2; on Days 1 and 7 for Cohort B2
Time to Reach Maximum Observed Concentration (Tmax) of NAL ER, Pirfenidone, and Nintedanib
Time frame: Pre-dose and at multiple timepoints post-dose on Days 1 and 6 for Cohorts A1 and B1; on Days 1 and 8 for Cohort A2; on Days 1 and 7 for Cohort B2
Area Under the Concentration-Time Curve From Time Zero to Time of Last Measurable Concentration (AUC0-Tlast) of NAL ER, Pirfenidone, and Nintedanib
Time frame: Pre-dose and at multiple timepoints post-dose on Days 1 and 6 for Cohorts A1 and B1; on Days 1 and 8 for Cohort A2; on Days 1 and 7 for Cohort B2
Area Under the Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of NAL ER, Pirfenidone, and Nintedanib
Time frame: Pre-dose and at multiple timepoints post-dose on Days 1 and 6 for Cohorts A1 and B1; on Days 1 and 8 for Cohort A2; on Days 1 and 7 for Cohort B2
Apparent Terminal Rate Constant (λz) of NAL ER, Pirfenidone, and Nintedanib
Time frame: Pre-dose and at multiple timepoints post-dose on Days 1 and 6 for Cohorts A1 and B1; on Days 1 and 8 for Cohort A2; on Days 1 and 7 for Cohort B2
Apparent Terminal Half-Life (t1/2) of NAL ER, Pirfenidone, and Nintedanib
Time frame: Pre-dose and at multiple timepoints post-dose on Days 1 and 6 for Cohorts A1 and B1; on Days 1 and 8 for Cohort A2; on Days 1 and 7 for Cohort B2
Apparent Clearance (CL/F) of NAL ER, Pirfenidone, and Nintedanib
Time frame: Pre-dose and at multiple timepoints post-dose on Days 1 and 6 for Cohorts A1 and B1; on Days 1 and 8 for Cohort A2; on Days 1 and 7 for Cohort B2
Apparent Volume of Distribution (Vz/F) of NAL ER, Pirfenidone, and Nintedanib
Time frame: Pre-dose and at multiple timepoints post-dose on Days 1 and 6 for Cohorts A1 and B1; on Days 1 and 8 for Cohort A2; on Days 1 and 7 for Cohort B2
2 secondary outcomes
Safety and Tolerability as Assessed by Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Time frame: Up to Day 21
Number of Participants With Clinically Significant Abnormalities in Vital Signs
Time frame: Up to Day 21
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 10 Oct 2025.
- Individual participant dataSharing planned: No
Related trials for Healthy Participants
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
RecruitingPhase 1
A Study to Evaluate the Metabolism, the Routes and Extent of Elimination, and Drug Levels of [14C]Navlimetostat (BMS-986504) in Healthy Female Participants
Healthy Female Participants
Not yet recruiting
REM Enhancement Sleep Technology for Well-being, Emotion, and Life Lift
Healthy Adult Participants
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, Pirfenidone and Nintedanib 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 13 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 10 Oct 2025. 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?
Maximum Plasma Concentration (Cmax) of NAL ER, Pirfenidone, and Nintedanib (time frame: Pre-dose and at multiple timepoints post-dose on Days 1 and 6 for Cohorts A1 and B1; on Days 1 and 8 for Cohort A2; on Days 1 and 7 for Cohort B2). The study lists 8 primary outcomes in all. 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 10 Oct 2025.