drugset / Trial / NCT04018664

Oral Abuse Potential Study of Nalbuphine

NCT04018664

Phase 1 Completed 56 enrolled Trevi Therapeutics Syneos Health · collab
Non-randomizedCrossoverTriple-blindOther

Summary

The purpose of this study is to measure the effects of a drug called nalbuphine (an opioid drug) compared with the effects of hydromorphone (an opioid drug) and placebo (contains no active drug ingredients). The amount of nalbuphine levels in the blood will also be measured and the safety of the study drugs will be evaluated. This study has 2 parts: Part A and Part B.

Timeline

Start
2018-05-29
Primary completion
2018-12-03
Completion
2020-06-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Nalbuphine Small molecule 90 mg Oral
Subject Nalbuphine Small molecule 120 mg Oral
Subject Nalbuphine Small molecule 150 mg Oral
Subject Nalbuphine Small molecule 180 mg Oral
Subject Nalbuphine Small molecule 270 mg Oral
Subject Nalbuphine Small molecule 405 mg Oral
Subject Nalbuphine Small molecule 540 mg Oral

Indications