CompletedPhase 1

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

22 participantsStarted 2013-04

Plain-language 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.

Who can participate

Age range18 Years – 70 Years

SexALL

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Inclusion criteria

✓. Patients with chronic renal failure who have been receiving chronic in-center HD on an average of 3 times a week for at least 3 months (with Kt/V \> 1.1).
✓. Subjects who experience at least mild intermittent pruritus.
✓. Non-reactive serology for hepatitis B, hepatitis C, and human immunodeficiency virus (HIV) antibody screens.
✓. Adequate venous access.
✓. Hemoglobin concentration at Screening \> 9 g/dL.
✓. Subjects are demographically comparable to the ESRD subjects.
✓. Gender matched 100%
✓. Age ± 10 years

Exclusion criteria

✕. Patients who had a significant alteration in dialysis regimen within 2 weeks of the Screening Visit.
✕. An alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) concentration \> 2x the upper limit of the normal range (ULN) at Screening.
✕. A serum total bilirubin \> 1.8x ULN.
✕. Patients who require peritoneal dialysis.
✕. Patients who received daily or when necessary (PRN) barbiturates, amphetamines, or opiates within 7 days prior to Check-in.
✕. Subjects with a positive drug screen at Screening and Day -1 without a prescription.
✕. Known hypersensitivity or allergy to nalbuphine or vehicle components.
✕. Known drug allergy to opioids.

What they're measuring

Steady state PK of nalbuphine HCl ER tablets as a function of dose

Timeframe: Day -1 to 14 Cohort 1 Groups 1-3 and Cohort 2; Day -1 to 17 Cohort 1 Group 4

Extent of extraction of nalbuphine by measuring nalbuphine in plasma and dialysate during dialysis

Timeframe: Day -1 to 14 Cohort 1 Groups 1-3; Day -1 to 17 Cohort 1 Group 4

Trial details

NCT IDNCT02373215

SponsorTrevi Therapeutics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2013-11

View on ClinicalTrials.gov More Uremic Pruritus trials