CompletedNCT04020016Updated Mar 19, 2026Results posted

Study of Nalbuphine ER in Participants With Hepatic Impairment

A Phase 1 interventional study of Nalbuphine ER in Hepatic Impairment, sponsored by Trevi Therapeutics. Completed at 3 sites in United States. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-19.

Sponsored by Trevi Therapeutics · Phase 1, Interventional, and Treatment

Phase: Phase 1
Study type: Interventional
Enrollment: 28
Allocation: Not applicable
Ages: 18 Years to 80 Years
Sex: All

Study summary

This research study will evaluate the effect of hepatic impairment on the pharmacokinetics (the breakdown of the drug in the body) of parallel-group, multiple oral doses nalbuphine extended release (NAL ER), tablets in people with hepatic impairment (mild, moderate and severe), compared to people with normal liver function. The study will also test the safety and tolerability of the NAL ER, when it is given to participants with mild, moderate and severe hepatic impairment, compared to participants with normal liver function. This protocol will also study the effects of this drug on itching in hepatic impairment participants if they report some itching prior to taking part in this study.

Conditions studied

Hepatic Impairment

Keywords

nalbuphine
Pharmacokinetic
hepatic impairment

In context

Lead sponsor

Trevi Therapeutics is the lead sponsor of 16 studies on the registry; 2 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 80 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

For participants with Hepatic Impairment (Cohort 1 to 4 and Cohort 6):

Male or female with stable hepatic impairment, non-smoker and/or light smoker.
Clinical diagnosis of liver cirrhosis
Stable for study participation based upon medical history, physical examination, vital signs, ECGs, and screening clinical laboratory evaluations

For Healthy participants (Cohort 5):

Male or female, non-smoker and/or light smoker (up to 5 cigarettes or equivalent/day)
Healthy as defined by:
- Normal hepatic function
- The absence of clinically significant illness and surgery within 4 weeks prior to dosing.

Exclusion criteria

Exclusion Criteria:

For participants with Hepatic Impairment (Cohort 1 to 4 and Cohort 6):

Clinically significant unstable medical conditions
Clinically significant abnormalities of laboratory, ECG, pulse oximetry, or clinical data that would preclude participation in the study.
History of any illness that might confound the results of the study or pose an additional risk to the participant by participation in the study.

For Healthy participants (Cohort 5):

Diagnosis of liver disease
History of heart problems.
History of significant alcohol abuse or drug abuse

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Sequential assignment
Masking: None (open label)
Enrollment: 28 participants (actual)

Study arms

Experimental
Part 1 Single Ascending Dose
Participants with mild (group 1), moderate (group 2) and severe (group 3) hepatic impairment received single dose ranging from 27 mg up to 162 mg of NAL ER tablet under fasting conditions. There was a washout period of at least 7 days between the drug administration between each dose level. Participants with no hepatic impairment (group 4) received a single dose of NAL ER of up to 162 mg under fasting conditions.
Drug: Nalbuphine ER

Interventions

DrugNalbuphine ER
Oral tablet
Also known as: NAL ER

What researchers measure

Primary outcomes

Part 1: Maximum Observed Plasma Concentration (Cmax) of NAL ER
Time frame: Pre-dose and 1.5, 3, 5, 7, 9, 12, 24, 36, 48, and 72 hours post-dose at Day 1 in each dose level
Part 1: Time to Reach Maximum Observed Plasma Concentration (Tmax) of NAL ER
Time frame: Pre-dose and 1.5, 3, 5, 7, 9, 12, 24, 36, 48, and 72 hours post-dose at Day 1 in each dose level
Part 1: Terminal Elimination Half-Life (T1/2 el) of NAL ER
Time frame: Pre-dose and 1.5, 3, 5, 7, 9, 12, 24, 36, 48, and 72 hours post-dose at Day 1 in each dose level
Part 1: Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of NAL ER
Time frame: Pre-dose and 1.5, 3, 5, 7, 9, 12, 24, 36, 48, and 72 hours post-dose at Day 1 in each dose level
Part 1: Area Under the Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUC0-t) of NAL ER
Time frame: Pre-dose and 1.5, 3, 5, 7, 9, 12, 24, 36, 48, and 72 hours post-dose at Day 1 in each dose level
Part 1: Number of Participants Who Experienced at Least One Treatment Emergent Adverse Event (TEAE)
An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A TEAE was defined as any AE that occurs after the first dose of study drug. TEAEs included both serious and non-serious TEAEs.
Time frame: From signing the informed consent form up to Day 4
Part 1: Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters
The clinical laboratory parameters included the clinical chemistry, hematology, coagulation, and urinalysis. Clinical significance was determined by the investigator.
Time frame: From signing the informed consent form up to Day 4
Part 1: Number of Participants With Clinically Significant Findings in Vital Sign Parameters
Vital signs measurements included diastolic and systolic blood pressure, heart rate, respiratory rate, and body temperature. Clinical significance was determined by the investigator.
Time frame: From signing the informed consent form up to Day 4
Part 1: Number of Participants With Clinically Significant Findings in Physical Examination Parameters
Physical examination included examination of at least the following components: head, eyes, ears, nose, throat (HEENT), neck, lungs, abdomen, skin, cardiovascular and musculoskeletal evaluation, and general neurological examination. Clinical significance was determined by the investigator.
Time frame: From signing the informed consent form up to Day 4
Part 1: Number of Participants With Clinically Significant Abnormalities in 12-Lead Electrocardiogram (ECG)
ECG data included the measurement of heart rate and aggregate PR interval, QRS duration, QT interval, QTcB interval, and QTcF interval.
Time frame: From signing the informed consent form up to Day 4
Part 1: Number of Participants With Clinically Significant Findings in Pulse Oximetry
Oxygen saturation was measured via pulse oximetry. Pulse oximetry measurements were to be collected within 10 min before or after the specified time point. Clinical significance was determined by the investigator.
Time frame: Pre-dose and 1.5, 4, 5, and 8 hours post-dose in each dose level

Secondary outcomes

Part 2: Change From Baseline in Worst Itch Numerical Rating Scale (WI-NRS)
WI-NRS measure was used determine the severity of itch experienced by participants with hepatic impairment (for Cohort 6 only) at screening. Participants were to complete the two forms (the "Night-time Itch" and the "Daytime Itch") at the same time during the screening visit and the average was taken to determine the baseline severity. The scale was a 0 to 10 rating scale with 10 being the most severe itch experienced and 0 being no itching experienced. Higher score indicated greater severity of itching.
Time frame: Baseline, Day 16

Results

Posted Mar 19, 2026

Limitations and caveats

As per the judgement of the safety committee, the Part 2 (MAD) was not conducted based on protocol defined criteria.

Participant flow

Participants were enrolled at 3 sites in the United States from 12 June 2019 to 05 February 2020.

Cohort 1

Participant flow — Cohort 1
Milestone	Cohort 1: NAL ER 27 mg	Cohort 2: NAL ER 54 mg	Cohort 3: NAL ER 108 mg	Cohort 4: NAL ER 162 mg	Cohort 5: NAL ER 162 mg
Started	16	0	0	0	0
Completed	16	0	0	0	0
Not completed	0	0	0	0	0

Cohort 2

Participant flow — Cohort 2
Milestone	Cohort 1: NAL ER 27 mg	Cohort 2: NAL ER 54 mg	Cohort 3: NAL ER 108 mg	Cohort 4: NAL ER 162 mg	Cohort 5: NAL ER 162 mg
Started	0	15	0	0	0
Completed	0	15	0	0	0
Not completed	0	0	0	0	0

Cohort 3

Participant flow — Cohort 3
Milestone	Cohort 1: NAL ER 27 mg	Cohort 2: NAL ER 54 mg	Cohort 3: NAL ER 108 mg	Cohort 4: NAL ER 162 mg	Cohort 5: NAL ER 162 mg
Started	0	0	15	0	0
Completed	0	0	15	0	0
Not completed	0	0	0	0	0

Cohorts 4 and 5

Participant flow — Cohorts 4 and 5
Milestone	Cohort 4: NAL ER 162 mg	Cohort 5: NAL ER 162 mg
Started	13	8
Completed	13	8
Not completed	0	0

Outcome measures

PrimaryPart 1: Maximum Observed Plasma Concentration (Cmax) of NAL ER

Time frame:: Pre-dose and 1.5, 3, 5, 7, 9, 12, 24, 36, 48, and 72 hours post-dose at Day 1 in each dose level
Reported as:: Geometric mean · nanogram per milliliter (ng/mL)

Part 1: Maximum Observed Plasma Concentration (Cmax) of NAL ER
nanogram per milliliter (ng/mL)	Cohort 1: NAL ER 27 mg	Cohort 2: NAL ER 54 mg	Cohort 3: NAL ER 108 mg	Cohort 4: NAL ER 162 mg	Cohort 5: NAL ER 162 mg
Mild Hepatic Impairment (Group 1)	3.30 ± 41.8	7.67 ± 38.9	13.9 ± 34.1	18.7 ± 34.9	—
Moderate Hepatic Impairment (Group 2)	10.9 ± 77.9	22.3 ± 70.7	42.4 ± 52.2	57.2 ± 55.3	—
Severe Hepatic Impairment (Group 3)	27.7 ± 21.9	—	—	—	—
No Hepatic Impairment (Group 4)	—	—	—	—	25.7 ± 34.2

PrimaryPart 1: Time to Reach Maximum Observed Plasma Concentration (Tmax) of NAL ER

Time frame:: Pre-dose and 1.5, 3, 5, 7, 9, 12, 24, 36, 48, and 72 hours post-dose at Day 1 in each dose level
Reported as:: Median · hours (h)

Part 1: Time to Reach Maximum Observed Plasma Concentration (Tmax) of NAL ER
hours (h)	Cohort 1: NAL ER 27 mg	Cohort 2: NAL ER 54 mg	Cohort 3: NAL ER 108 mg	Cohort 4: NAL ER 162 mg	Cohort 5: NAL ER 162 mg
Mild Hepatic Impairment (Group 1)	4.000 (1.500 to 7.000)	5.000 (3.000 to 12.000)	5.000 (1.500 to 12000)	7.000 (3.000 to 24.000)	—
Moderate Hepatic Impairment (Group 2)	3.000 (3.000 to 9.000)	5.000 (3.000 to 12.067)	9.000 (3.000 to 12.000)	7.000 (3.000 to 12.000)	—
Severe Hepatic Impairment (Group 3)	6.000 (3.000 to 9.000)	—	—	—	—
No Hepatic Impairment (Group 4)	—	—	—	—	5.000 (2.983 to 9.000)

PrimaryPart 1: Terminal Elimination Half-Life (T1/2 el) of NAL ER

Time frame:: Pre-dose and 1.5, 3, 5, 7, 9, 12, 24, 36, 48, and 72 hours post-dose at Day 1 in each dose level
Reported as:: Median · h

Part 1: Terminal Elimination Half-Life (T1/2 el) of NAL ER
h	Cohort 1: NAL ER 27 mg	Cohort 2: NAL ER 54 mg	Cohort 3: NAL ER 108 mg	Cohort 4: NAL ER 162 mg	Cohort 5: NAL ER 162 mg
Mild Hepatic Impairment (Group 1)	7.83 (6.46 to 12.27)	11.92 (7.94 to 14.08)	8.80 (4.95 to 12.05)	9.55 (7.14 to 11.49)	—
Moderate Hepatic Impairment (Group 2)	7.97 (5.15 to 11.77)	7.56 (5.82 to 10.36)	7.81 (5.92 to 11.63)	8.25 (5.48 to 13.69)	—
Severe Hepatic Impairment (Group 3)	7.22 (6.24 to 8.02)	—	—	—	—
No Hepatic Impairment (Group 4)	—	—	—	—	10.00 (6.84 to 14.09)

PrimaryPart 1: Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of NAL ER

Time frame:: Pre-dose and 1.5, 3, 5, 7, 9, 12, 24, 36, 48, and 72 hours post-dose at Day 1 in each dose level
Reported as:: Geometric mean · hour-nanogram per milliliter (h*ng/mL)

Part 1: Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of NAL ER
hour-nanogram per milliliter (h*ng/mL)	Cohort 1: NAL ER 27 mg	Cohort 2: NAL ER 54 mg	Cohort 3: NAL ER 108 mg	Cohort 4: NAL ER 162 mg	Cohort 5: NAL ER 162 mg
Mild Hepatic Impairment (Group 1)	68.15 ± 36.63	141.56 ± 42.73	300.09 ± 32.28	356.12 ± 34.16	—
Moderate Hepatic Impairment (Group 2)	194.12 ± 79.81	396.03 ± 74.70	846.41 ± 61.11	1074.11 ± 62.42	—
Severe Hepatic Impairment (Group 3)	491.26 ± 20.21	—	—	—	—
No Hepatic Impairment (Group 4)	—	—	—	—	374.83 ± 67.77

PrimaryPart 1: Area Under the Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUC0-t) of NAL ER

Time frame:: Pre-dose and 1.5, 3, 5, 7, 9, 12, 24, 36, 48, and 72 hours post-dose at Day 1 in each dose level
Reported as:: Geometric mean · h*ng/mL

Part 1: Area Under the Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUC0-t) of NAL ER
h*ng/mL	Cohort 1: NAL ER 27 mg	Cohort 2: NAL ER 54 mg	Cohort 3: NAL ER 108 mg	Cohort 4: NAL ER 162 mg	Cohort 5: NAL ER 162 mg
Mild Hepatic Impairment (Group 1)	40.82 ± 62.46	114.96 ± 45.27	250.97 ± 39.10	357.32 ± 31.57	—
Moderate Hepatic Impairment (Group 2)	180.63 ± 83.26	377.56 ± 76.03	830.15 ± 61.84	1050.63 ± 63.55	—
Severe Hepatic Impairment (Group 3)	482.29 ± 20.14	—	—	—	—
No Hepatic Impairment (Group 4)	—	—	—	—	355.42 ± 70.21

PrimaryPart 1: Number of Participants Who Experienced at Least One Treatment Emergent Adverse Event (TEAE)

An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A TEAE was defined as any AE that occurs after the first dose of study drug. TEAEs included both serious and non-serious TEAEs.

Time frame:: From signing the informed consent form up to Day 4
Reported as:: Count of participants · Participants

Part 1: Number of Participants Who Experienced at Least One Treatment Emergent Adverse Event (TEAE)
Participants	Cohort 1: NAL ER 27 mg	Cohort 2: NAL ER 54 mg	Cohort 3: NAL ER 108 mg	Cohort 4: NAL ER 162 mg	Cohort 5: NAL ER 162 mg
Part 1: Number of Participants Who Experienced at Least One Treatment Emergent Adverse Event (TEAE)	3	5	9	12	5

PrimaryPart 1: Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters

The clinical laboratory parameters included the clinical chemistry, hematology, coagulation, and urinalysis. Clinical significance was determined by the investigator.

Time frame:: From signing the informed consent form up to Day 4
Reported as:: Count of participants · Participants

Part 1: Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters
Participants	Cohort 1: NAL ER 27 mg	Cohort 2: NAL ER 54 mg	Cohort 3: NAL ER 108 mg	Cohort 4: NAL ER 162 mg	Cohort 5: NAL ER 162 mg
Part 1: Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters	0	0	0	0	0

PrimaryPart 1: Number of Participants With Clinically Significant Findings in Vital Sign Parameters

Vital signs measurements included diastolic and systolic blood pressure, heart rate, respiratory rate, and body temperature. Clinical significance was determined by the investigator.

Time frame:: From signing the informed consent form up to Day 4
Reported as:: Count of participants · Participants

Part 1: Number of Participants With Clinically Significant Findings in Vital Sign Parameters
Participants	Cohort 1: NAL ER 27 mg	Cohort 2: NAL ER 54 mg	Cohort 3: NAL ER 108 mg	Cohort 4: NAL ER 162 mg	Cohort 5: NAL ER 162 mg
Part 1: Number of Participants With Clinically Significant Findings in Vital Sign Parameters	0	0	0	0	0

PrimaryPart 1: Number of Participants With Clinically Significant Findings in Physical Examination Parameters

Physical examination included examination of at least the following components: head, eyes, ears, nose, throat (HEENT), neck, lungs, abdomen, skin, cardiovascular and musculoskeletal evaluation, and general neurological examination. Clinical significance was determined by the investigator.

Time frame:: From signing the informed consent form up to Day 4
Reported as:: Count of participants · Participants

Part 1: Number of Participants With Clinically Significant Findings in Physical Examination Parameters
Participants	Cohort 1: NAL ER 27 mg	Cohort 2: NAL ER 54 mg	Cohort 3: NAL ER 108 mg	Cohort 4: NAL ER 162 mg	Cohort 5: NAL ER 162 mg
Part 1: Number of Participants With Clinically Significant Findings in Physical Examination Parameters	0	0	0	0	0

PrimaryPart 1: Number of Participants With Clinically Significant Abnormalities in 12-Lead Electrocardiogram (ECG)

ECG data included the measurement of heart rate and aggregate PR interval, QRS duration, QT interval, QTcB interval, and QTcF interval.

Time frame:: From signing the informed consent form up to Day 4
Reported as:: Count of participants · Participants

Part 1: Number of Participants With Clinically Significant Abnormalities in 12-Lead Electrocardiogram (ECG)
Participants	Cohort 1: NAL ER 27 mg	Cohort 2: NAL ER 54 mg	Cohort 3: NAL ER 108 mg	Cohort 4: NAL ER 162 mg	Cohort 5: NAL ER 162 mg
Part 1: Number of Participants With Clinically Significant Abnormalities in 12-Lead Electrocardiogram (ECG)	0	0	0	0	0

PrimaryPart 1: Number of Participants With Clinically Significant Findings in Pulse Oximetry

Oxygen saturation was measured via pulse oximetry. Pulse oximetry measurements were to be collected within 10 min before or after the specified time point. Clinical significance was determined by the investigator.

Time frame:: Pre-dose and 1.5, 4, 5, and 8 hours post-dose in each dose level
Reported as:: Count of participants · Participants

Part 1: Number of Participants With Clinically Significant Findings in Pulse Oximetry
Participants	Cohort 1: NAL ER 27 mg	Cohort 2: NAL ER 54 mg	Cohort 3: NAL ER 108 mg	Cohort 4: NAL ER 162 mg	Cohort 5: NAL ER 162 mg
Part 1: Number of Participants With Clinically Significant Findings in Pulse Oximetry	0	0	0	0	0

SecondaryPart 2: Change From Baseline in Worst Itch Numerical Rating Scale (WI-NRS)

WI-NRS measure was used determine the severity of itch experienced by participants with hepatic impairment (for Cohort 6 only) at screening. Participants were to complete the two forms (the "Night-time Itch" and the "Daytime Itch") at the same time during the screening visit and the average was taken to determine the baseline severity. The scale was a 0 to 10 rating scale with 10 being the most severe itch experienced and 0 being no itching experienced. Higher score indicated greater severity of itching.

Time frame:: Baseline, Day 16

No measurements were reported for this outcome.

Adverse events

Collected over From the time of signing informed consent form to Day 4. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Cohort 1: NAL ER 27 mg	0/16 (0%)	0/16 (0%)	3/16 (18.8%)
Cohort 2: NAL ER 54 mg	0/15 (0%)	0/15 (0%)	5/15 (33.3%)
Cohort 3: NAL ER 108 mg	0/15 (0%)	0/15 (0%)	9/15 (60%)
Cohort 4: NAL ER 162 mg	0/13 (0%)	0/13 (0%)	12/13 (92.3%)
Cohort 5: NAL ER 162 mg	0/8 (0%)	0/8 (0%)	5/8 (62.5%)

Most frequent other events

Showing 10 of 15

Most frequent other events
Event	Cohort 1: NAL ER 27 mg	Cohort 2: NAL ER 54 mg	Cohort 3: NAL ER 108 mg	Cohort 4: NAL ER 162 mg	Cohort 5: NAL ER 162 mg
Euphoric MoodPsychiatric disorders	0/16	0/15	2/15	7/13	0/8
SomnolenceNervous system disorders	0/16	3/15	6/15	3/13	2/8
VomitingGastrointestinal disorders	2/16	1/15	0/15	1/13	3/8
Feeling of RelaxationGeneral disorders	0/16	0/15	0/15	0/13	2/8
Dry MouthGastrointestinal disorders	0/16	0/15	0/15	2/13	0/8
HeadacheNervous system disorders	0/16	0/15	2/15	0/13	0/8
NauseaGastrointestinal disorders	1/16	0/15	1/15	0/13	1/8
Ventricular arrhythmiaCardiac disorders	0/16	0/15	1/15	0/13	1/8
PruritusSkin and subcutaneous tissue disorders	0/16	0/15	0/15	1/13	0/8
ParaesthesiaNervous system disorders	0/16	0/15	0/15	1/13	0/8

Baseline characteristics

Safety analysis set (SAS) included all enrolled participants who had received at least 1 dose of study drug.

Age, Continuous
Age, Continuous(years)	Part 1: All Participants
Cohort 1 (NAL ER 27 mg): Group 1	59.2 ± 5.6
Cohort 1 (NAL ER 27 mg): Group 2	62.5 ± 5.1
Cohort 1 (NAL ER 27 mg): Group 3	60.3 ± 9.0
Cohort 2 (NAL ER 54 mg): Group 1	59.5 ± 4.9
Cohort 2 (NAL ER 54 mg): Group 2	61.3 ± 5.6
Cohort 3 (NAL ER 108 mg): Group 1	59.5 ± 4.9
Cohort 3 (NAL ER 108 mg): Group 2	60.3 ± 6.1
Cohort 4 (NAL ER 162 mg): Group 1	59.3 ± 5.3
Cohort 4 (NAL ER 162 mg): Group 2	58.8 ± 5.2
Cohort 5 (NAL ER 162 mg): Group 4	55.9 ± 5.7

Sex: Female, Male
Sex: Female, Male(Participants)	Part 1: All Participants
Cohort 1 (NAL ER 27 mg): Group 1 — Female	3
Cohort 1 (NAL ER 27 mg): Group 1 — Male	3
Cohort 1 (NAL ER 27 mg): Group 2 — Female	1
Cohort 1 (NAL ER 27 mg): Group 2 — Male	5
Cohort 1 (NAL ER 27 mg): Group 3 — Female	2
Cohort 1 (NAL ER 27 mg): Group 3 — Male	2
Cohort 2 (NAL ER 54 mg): Group 1 — Female	4
Cohort 2 (NAL ER 54 mg): Group 1 — Male	4
Cohort 2 (NAL ER 54 mg): Group 2 — Female	1
Cohort 2 (NAL ER 54 mg): Group 2 — Male	6
Cohort 3 (NAL ER 108 mg): Group 1 — Female	4
Cohort 3 (NAL ER 108 mg): Group 1 — Male	4
Cohort 3 (NAL ER 108 mg): Group 2 — Female	0
Cohort 3 (NAL ER 108 mg): Group 2 — Male	7
Cohort 4 (NAL ER 162 mg): Group 1 — Female	3
Cohort 4 (NAL ER 162 mg): Group 1 — Male	4
Cohort 4 (NAL ER 162 mg): Group 2 — Female	0
Cohort 4 (NAL ER 162 mg): Group 2 — Male	6
Cohort 5 (NAL ER 162 mg): Group 4 — Female	3
Cohort 5 (NAL ER 162 mg): Group 4 — Male	5

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Part 1: All Participants
Cohort 1 (NAL ER 27 mg): Group 1 — Hispanic or Latino	0
Cohort 1 (NAL ER 27 mg): Group 1 — Not Hispanic or Latino	6
Cohort 1 (NAL ER 27 mg): Group 1 — Unknown or Not Reported	0
Cohort 1 (NAL ER 27 mg): Group 2 — Hispanic or Latino	0
Cohort 1 (NAL ER 27 mg): Group 2 — Not Hispanic or Latino	6
Cohort 1 (NAL ER 27 mg): Group 2 — Unknown or Not Reported	0
Cohort 1 (NAL ER 27 mg): Group 3 — Hispanic or Latino	1
Cohort 1 (NAL ER 27 mg): Group 3 — Not Hispanic or Latino	3
Cohort 1 (NAL ER 27 mg): Group 3 — Unknown or Not Reported	0
Cohort 2 (NAL ER 54 mg): Group 1 — Hispanic or Latino	1
Cohort 2 (NAL ER 54 mg): Group 1 — Not Hispanic or Latino	7
Cohort 2 (NAL ER 54 mg): Group 1 — Unknown or Not Reported	0
Cohort 2 (NAL ER 54 mg): Group 2 — Hispanic or Latino	1
Cohort 2 (NAL ER 54 mg): Group 2 — Not Hispanic or Latino	6
Cohort 2 (NAL ER 54 mg): Group 2 — Unknown or Not Reported	0
Cohort 3 (NAL ER 108 mg): Group 1 — Hispanic or Latino	4
Cohort 3 (NAL ER 108 mg): Group 1 — Not Hispanic or Latino	4
Cohort 3 (NAL ER 108 mg): Group 1 — Unknown or Not Reported	0
Cohort 3 (NAL ER 108 mg): Group 2 — Hispanic or Latino	0
Cohort 3 (NAL ER 108 mg): Group 2 — Not Hispanic or Latino	7
Cohort 3 (NAL ER 108 mg): Group 2 — Unknown or Not Reported	0
Cohort 4 (NAL ER 162 mg): Group 1 — Hispanic or Latino	3
Cohort 4 (NAL ER 162 mg): Group 1 — Not Hispanic or Latino	4
Cohort 4 (NAL ER 162 mg): Group 1 — Unknown or Not Reported	0
Cohort 4 (NAL ER 162 mg): Group 2 — Hispanic or Latino	0
Cohort 4 (NAL ER 162 mg): Group 2 — Not Hispanic or Latino	6
Cohort 4 (NAL ER 162 mg): Group 2 — Unknown or Not Reported	0
Cohort 5 (NAL ER 162 mg): Group 4 — Hispanic or Latino	3
Cohort 5 (NAL ER 162 mg): Group 4 — Not Hispanic or Latino	5
Cohort 5 (NAL ER 162 mg): Group 4 — Unknown or Not Reported	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Part 1: All Participants
Cohort 1 (NAL ER 27 mg): Group 1 — American Indian or Alaska Native	0
Cohort 1 (NAL ER 27 mg): Group 1 — Asian	1
Cohort 1 (NAL ER 27 mg): Group 1 — Native Hawaiian or Other Pacific Islander	0
Cohort 1 (NAL ER 27 mg): Group 1 — Black or African American	3
Cohort 1 (NAL ER 27 mg): Group 1 — White	2
Cohort 1 (NAL ER 27 mg): Group 1 — More than one race	0
Cohort 1 (NAL ER 27 mg): Group 1 — Unknown or Not Reported	0
Cohort 1 (NAL ER 27 mg): Group 2 — American Indian or Alaska Native	0
Cohort 1 (NAL ER 27 mg): Group 2 — Asian	0
Cohort 1 (NAL ER 27 mg): Group 2 — Native Hawaiian or Other Pacific Islander	0
Cohort 1 (NAL ER 27 mg): Group 2 — Black or African American	2
Cohort 1 (NAL ER 27 mg): Group 2 — White	4
Cohort 1 (NAL ER 27 mg): Group 2 — More than one race	0
Cohort 1 (NAL ER 27 mg): Group 2 — Unknown or Not Reported	0
Cohort 1 (NAL ER 27 mg): Group 3 — American Indian or Alaska Native	0
Cohort 1 (NAL ER 27 mg): Group 3 — Asian	0
Cohort 1 (NAL ER 27 mg): Group 3 — Native Hawaiian or Other Pacific Islander	0
Cohort 1 (NAL ER 27 mg): Group 3 — Black or African American	1
Cohort 1 (NAL ER 27 mg): Group 3 — White	3
Cohort 1 (NAL ER 27 mg): Group 3 — More than one race	0
Cohort 1 (NAL ER 27 mg): Group 3 — Unknown or Not Reported	0
Cohort 2 (NAL ER 54 mg): Group 1 — American Indian or Alaska Native	0
Cohort 2 (NAL ER 54 mg): Group 1 — Asian	1
Cohort 2 (NAL ER 54 mg): Group 1 — Native Hawaiian or Other Pacific Islander	0
Cohort 2 (NAL ER 54 mg): Group 1 — Black or African American	3
Cohort 2 (NAL ER 54 mg): Group 1 — White	4
Cohort 2 (NAL ER 54 mg): Group 1 — More than one race	0
Cohort 2 (NAL ER 54 mg): Group 1 — Unknown or Not Reported	0
Cohort 2 (NAL ER 54 mg): Group 2 — American Indian or Alaska Native	0
Cohort 2 (NAL ER 54 mg): Group 2 — Asian	0
Cohort 2 (NAL ER 54 mg): Group 2 — Native Hawaiian or Other Pacific Islander	0
Cohort 2 (NAL ER 54 mg): Group 2 — Black or African American	2
Cohort 2 (NAL ER 54 mg): Group 2 — White	5
Cohort 2 (NAL ER 54 mg): Group 2 — More than one race	0
Cohort 2 (NAL ER 54 mg): Group 2 — Unknown or Not Reported	0
Cohort 3 (NAL ER 108 mg): Group 1 — American Indian or Alaska Native	0
Cohort 3 (NAL ER 108 mg): Group 1 — Asian	1
Cohort 3 (NAL ER 108 mg): Group 1 — Native Hawaiian or Other Pacific Islander	0
Cohort 3 (NAL ER 108 mg): Group 1 — Black or African American	3
Cohort 3 (NAL ER 108 mg): Group 1 — White	4
Cohort 3 (NAL ER 108 mg): Group 1 — More than one race	0
Cohort 3 (NAL ER 108 mg): Group 1 — Unknown or Not Reported	0
Cohort 3 (NAL ER 108 mg): Group 2 — American Indian or Alaska Native	0
Cohort 3 (NAL ER 108 mg): Group 2 — Asian	0
Cohort 3 (NAL ER 108 mg): Group 2 — Native Hawaiian or Other Pacific Islander	0
Cohort 3 (NAL ER 108 mg): Group 2 — Black or African American	1
Cohort 3 (NAL ER 108 mg): Group 2 — White	6
Cohort 3 (NAL ER 108 mg): Group 2 — More than one race	0
Cohort 3 (NAL ER 108 mg): Group 2 — Unknown or Not Reported	0
Cohort 4 (NAL ER 162 mg): Group 1 — American Indian or Alaska Native	0
Cohort 4 (NAL ER 162 mg): Group 1 — Asian	0
Cohort 4 (NAL ER 162 mg): Group 1 — Native Hawaiian or Other Pacific Islander	0
Cohort 4 (NAL ER 162 mg): Group 1 — Black or African American	3
Cohort 4 (NAL ER 162 mg): Group 1 — White	4
Cohort 4 (NAL ER 162 mg): Group 1 — More than one race	0
Cohort 4 (NAL ER 162 mg): Group 1 — Unknown or Not Reported	0
Cohort 4 (NAL ER 162 mg): Group 2 — American Indian or Alaska Native	0
Cohort 4 (NAL ER 162 mg): Group 2 — Asian	0
Cohort 4 (NAL ER 162 mg): Group 2 — Native Hawaiian or Other Pacific Islander	0
Cohort 4 (NAL ER 162 mg): Group 2 — Black or African American	1
Cohort 4 (NAL ER 162 mg): Group 2 — White	5
Cohort 4 (NAL ER 162 mg): Group 2 — More than one race	0
Cohort 4 (NAL ER 162 mg): Group 2 — Unknown or Not Reported	0
Cohort 5 (NAL ER 162 mg): Group 4 — American Indian or Alaska Native	0
Cohort 5 (NAL ER 162 mg): Group 4 — Asian	0
Cohort 5 (NAL ER 162 mg): Group 4 — Native Hawaiian or Other Pacific Islander	0
Cohort 5 (NAL ER 162 mg): Group 4 — Black or African American	2
Cohort 5 (NAL ER 162 mg): Group 4 — White	6
Cohort 5 (NAL ER 162 mg): Group 4 — More than one race	0
Cohort 5 (NAL ER 162 mg): Group 4 — Unknown or Not Reported	0

Study locations

3 sites

01
Miami, Florida 33136, United States
02
Miami, Florida 33146, United States
03
Orlando, Florida 32809, United States

References and documents

Study documents

Study protocol · Nov 5, 2019
Statistical analysis plan · Jan 21, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Mar 19, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04020016
Lead sponsor: Trevi Therapeutics
Collaborators: Syneos Health
Responsible party: Sponsor
First posted: Jul 15, 2019
Start date: Jun 12, 2019
Primary completion: Feb 5, 2020
Completion: Feb 5, 2020
Results posted: Mar 19, 2026
Last update: Mar 19, 2026

Study contacts

Chief Development Officer

study director · Trevi Therapeutics, Inc.

Oversight

Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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