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A Trial to Evaluate the Abuse Potential of 3 Doses of GRT6005 in Adult Non-dependent Recreational Opioid Users

NCT03757559 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 226

Last updated 2021-07-15

No results posted yet for this study

Summary

The primary objective of this study was to evaluate the abuse potential of single doses of cebranopadol (GRT6005) relative to hydromorphone (immediate-release formulation \[IR\] and placebo in 48 non-dependent recreational opioid users.

Secondary objectives were to evaluate the abuse potential of hydromorphone IR compared to placebo (trial validation), to evaluate the safety and tolerability of single doses of cebranopadol (200, 400, and 800 micrograms), and to evaluate pharmacokinetics (PK) of cebranopadol and optionally some of its metabolites.

Conditions

  • Abuse, Drug

Interventions

DRUG

Cebranopadol 100 micrograms

Tablets were taken under fasted conditions with non-carbonated water.

DRUG

Cebranopadol 400 micrograms

Tablets were taken under fasted conditions with non-carbonated water.

DRUG

Hydromorphone hydrochloride 4 milligrams

Over-encapsulated immediate-release tablets were taken under fasted conditions with non-carbonated water.

DRUG

Placebo matching hydromorphone

Placebo matching over-encapsulated hydromorphone tablets were taken under fasted conditions with non-carbonated water.

DRUG

Placebo matching cebranopadol

Placebo matching cebranopadol tablets were taken under fasted conditions with non-carbonated water.

Sponsors & Collaborators

  • Tris Pharma, Inc.

    lead INDUSTRY

Principal Investigators

  • Grünenthal Study Director · Grünenthal GmbH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2013-04-15
Primary Completion
2014-03-08
Completion
2014-03-08

Countries

  • Canada

Study Locations

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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 NCT03757559 on ClinicalTrials.gov