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NAL

Phase 1

Healthy Participants | Small molecule | Other |Trevi Therapeutics, Inc.|Last Updated: Mar 23, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedCONTROLLEDDMCBiomarker
Total Trials2
Total Enrollment192
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07487740A Food Effect Study to Evaluate the Relative Bioavailability of Nalbuphine Extended-Release Tablets (NAL ER) in Healthy ParticipantsPHASE1 RECRUITING 60 — — Feb 27, 2026Apr 1, 2026Mar 23, 20261 United States
NCT07015398A Study of the Pharmacokinetic Interaction Between Pirfenidone, Nintedanib, and Nalbuphine Extended Release (NAL ER) in Healthy ParticipantsPHASE1 COMPLETED 132 — — Jun 30, 2025Sep 26, 2025Oct 10, 20251 United States
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Study Endpoints
Primary Endpoints
Relative Bioavailability of NAL ER
Predose and at multiple timepoints postdose (from Day 1 to Day 8)
Maximum Plasma Concentration (Cmax) of NAL ER, Pirfenidone, and Nintedanib
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
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
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
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
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
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
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
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 Endpoints
Maximum Plasma Concentration (Cmax) of NAL ER
Predose and at multiple timepoints postdose (from Day 1 to Day 8)
Time to Reach Maximum Observed Concentration (Tmax) of NAL ER
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
Predose and at multiple timepoints postdose (from Day 1 to Day 8)
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Cohort 1: NAL ER Dose AEXPERIMENTALParticipants 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 BEXPERIMENTALParticipants 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.
Cohort A1 - NAL ER + PirfenidoneEXPERIMENTALParticipants will receive NAL ER followed by NAL ER co-administered with pirfenidone.
Cohort A2 - NAL ER + NintedanibEXPERIMENTALParticipants will receive NAL ER followed by NAL ER co-administered with nintedanib.
Cohort B1 - Pirfenidone + NAL EREXPERIMENTALParticipants will receive pirfenidone followed by pirfenidone co-administered with NAL ER.
Cohort B2 - Nintedanib + NAL EREXPERIMENTALParticipants will receive nintedanib followed by nintedanib co-administered with NAL ER.
Interventions
NameTypeDescription
NAL ERDRUGOral tablets
PirfenidoneDRUGOral tablets
NintedanibDRUGOral capsules
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Eligibility Criteria
Age Range18 Years — 60 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * 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 investiga...

Countries:United States
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT07487740primaryCompletionDate: changed
LOWMay 24, 2026NCT07487740studyFirstPostDate: changed