MedTrace Logo

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

NCT03768024 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2018-12-07

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Grünenthal GmbH

    lead INDUSTRY

Principal Investigators

  • Grünenthal Study Director · Grünenthal GmbH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-06-21
Primary Completion
2007-10-25
Completion
2007-10-25

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03768024 on ClinicalTrials.gov