Phase 1 Study of Nalbuphine HCl ER Tablets in Hemodialysis Patients With Uremic Pruritus

Phase 1 Completed 22 enrolled Trevi Therapeutics Davita Clinical Research · collab

Non-randomizedParallel-groupOpen-labelTreatment

Summary

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.

Timeline

Start: 2013-04
Primary completion: 2013-11
Completion: 2013-11

Publications

Eudy-Byrne R, Riggs M, Hawi A, Sciascia T, Rohatagi S. A population pharmacokinetic-pharmacodynamic model evaluating efficacy of nalbuphine extended-release in patients with prurigo nodularis. Br J Clin Pharmacol. 2023 Jul;89(7):2088-2101. doi: 10.1111/bcp.15663. Epub 2023 Feb 9.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Nalbuphine	Small molecule	180 mg	Oral
Subject	Nalbuphine	Small molecule	240 mg	Oral

Indications

No indication recorded.