NCT02373215 is a Phase 1 clinical trial of Nalbuphine HCL ER in Uremic Pruritus, sponsored by Trevi Therapeutics.

Who is sponsoring NCT02373215?

NCT02373215 is sponsored by Trevi Therapeutics.

What drugs are being tested in NCT02373215?

Interventions in NCT02373215: Nalbuphine HCL ER.

What condition does NCT02373215 study?

NCT02373215 studies Uremic Pruritus.

Is NCT02373215 still recruiting?

NCT02373215 is currently completed. Last updated 19 May 2025.

Last reviewed 2025-05-19 · How we verify

NCT02373215

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Phase 1, Open-Label, Non-Randomized, Parallel-Group Study to Characterize and Compare the Pharmacokinetics, Safety, and Tolerability of Escalating Oral Doses of Nalbuphine Hydrochloride Extended Release Tablets in End-Stage Renal Disease Patients on Hemodialysis and Matched Healthy Control Subjects

Completed Phase 1 Last updated 19 May 2025

What this trial tests

Phase 1 trial testing Nalbuphine HCL ER in Uremic Pruritus in 22 participants. Completed in 1 November 2013.

Timeline

1 April 2013

Primary endpoint
1 November 2013

1 November 2013

Quick facts

Lead sponsor	Trevi Therapeutics
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	22
Start date	1 April 2013
Primary completion	1 November 2013
Estimated completion	1 November 2013

Drugs / interventions tested

Nalbuphine HCL ER

Conditions studied

Uremic Pruritus — all drugs for Uremic Pruritus →

Sponsor

Trevi Therapeutics — full company profile →

Who can join

Adults 18 to 70, any sex, with Uremic Pruritus. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Steady state PK of nalbuphine HCl ER tablets as a function of dose
Time frame: Day -1 to 14 Cohort 1 Groups 1-3 and Cohort 2; Day -1 to 17 Cohort 1 Group 4
Steady state PK of nalbuphine HCl ER tablets following escalating repeated oral doses in ESRD patients receiving HD therapy relative to healthy subjects
Extent of extraction of nalbuphine by measuring nalbuphine in plasma and dialysate during dialysis
Time frame: Day -1 to 14 Cohort 1 Groups 1-3; Day -1 to 17 Cohort 1 Group 4
Extraction by dialysis was assessed by measuring nalbuphine concentrations in plasma during dialysis obtained from arterial (pre-dialyzer) and venous access ports (post-dialyzer) and by measuring the amount removed in the dialysate during dialysis in the dialysate as a function of dose.

Sponsor's own description

This is a single-center clinical research study with the purpose to evaluate the safety, tolerability, and pharmacokinetics (PK) of nalbuphine HCl ER (extended release) tablets in end-stage renal disease (ESRD) patients receiving hemodialysis (HD) therapy and reporting pruritus.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

Neuroimmune interactions in chronic itch of atopic dermatitis.
Yosipovitch G, Berger T, Fassett MS. · · 2020 · cited 113× · PMID 31566796 · DOI 10.1111/jdv.15973
Pharmacokinetics of nalbuphine hydrochloride extended release tablets in hemodialysis patients with exploratory effect on pruritus.
Hawi A, Alcorn H, Berg J, Hines C, et al · · 2015 · cited 40× · PMID 25885112 · DOI 10.1186/s12882-015-0043-3
A population pharmacokinetic-pharmacodynamic model evaluating efficacy of nalbuphine extended-release in patients with prurigo nodularis.
Eudy-Byrne R, Riggs M, Hawi A, Sciascia T, et al · · 2023 · cited 1× · PMID 36680419 · DOI 10.1111/bcp.15663
A Population Pharmacokinetic-Pharmacodynamic Model Evaluating Efficacy of Nalbuphine Extended-Release in Patients with Prurigo Nodularis
Eudy-Byrne R, Riggs M, Hawi A, Sciascia T, et al · · 2022 · DOI 10.22541/au.166177100.03899983/v1

Verify or expand the search:

Other recruiting trials for Uremic Pruritus

Currently open trials in the same condition.

NCT06446310 — Phase 3 Study of QLG2198 in Haemodialysis Chinese Adult Subjects With Moderate-to-Severe Pruritus · Phase 3 · recruiting

Other Trevi Therapeutics trials

Trials by the same sponsor.

NCT07036029 — NAL ER IPF Respiratory Function and Safety Study · Phase 1 · recruiting
NCT07015398 — A Study of the Pharmacokinetic Interaction Between Pirfenidone, Nintedanib, and Nalbuphine Extended Release (NAL ER) in · Phase 1 · completed
NCT05964335 — Cough Reduction in IPF With Nalbuphine ER · Phase 2 · completed
NCT05962151 — Refractory Chronic Cough Improvement Via NAL ER (RIVER) · Phase 2 · completed
NCT04030026 — A Study of Nalbuphine (Extended Release) ER in Idiopathic Pulmonary Fibrosis (IPF) for Treatment of Cough · Phase 2 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02373215 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Trevi Therapeutics
Last refreshed: 19 May 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02373215.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing