NCT03768024

A Clinical Study in Healthy Adults Who Sometimes Take Drugs for Pleasure Which Aims to Evaluate Whether GRT0151Y is Likely to be Abused

A Single-Dose, Randomized, Double Blind, Placebo and Active Controlled Cross-Over Study to Evaluate the Abuse Potential of Three Doses of GRT0151Y in Adult Non-dependent Recreational Opiate Users

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 76 (actual)
• Sponsor: Grünenthal GmbH · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this clinical study was to evaluate whether healthy adults, who sometimes take drugs for pleasure, are likely to abuse GRT0151Y. This abuse potential is assessed at three different doses of GRT0151Y. During a Qualification Phase, a single dose of hydromorphone IR 8 mg and a single dose of placebo were separately administered orally over 4 days in a randomized, double-blinded manner. During the Treatment Phase, single doses of GRT0151Y free base (100 mg, 200 mg and 400 mg), hydromorphone Immediate-release (IR) (4 mg, 8 mg, and 16 mg), and placebo were administered orally over 7 Treatment Periods. Participants received the treatments according to a 7-sequence, 7-period balanced design.

Conditions

• Pain
• Acute Pain

Interventions

Type	Name	Description
DRUG	GRT0151Y 50 mg capsule	GRT0151Y 50 mg capsule
DRUG	Hydromorphone IR 4 mg	Hydromorphone IR 4 mg tablet (encapsulated)
DRUG	Matching placebo	Matching placebo

Timeline

• Start date: 2007-06-21
• Primary completion: 2007-10-25
• Completion: 2007-10-25
• First posted: 2018-12-07
• Last updated: 2018-12-07

Locations

1 site across 1 country: Canada