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A Clinical Study in Healthy Adults Who Sometimes Take Drugs for Pleasure to Investigate the Safety and Tolerability of GRT0151Y and to Find Out Which Single Dose of the Compound is Maximally Tolerated

NCT03765658 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2018-12-05

No results posted yet for this study

Summary

The purpose of this study is to determine the maximum dose of GRT0151Y that is tolerable and to explore the safety profile of the drug.

For each Treatment Period (Visits 2-5), dosing will be separated by at least one week. Participants in this study will receive up to four doses of the study drug and up to two placebo (an inactive substance) preparations, one at a time on each of up to six visits. Participants will receive a single dose of either GRT0151Y or placebo beginning with the lowest dose of study drug 150 milligrams (mg), followed by 200 mg, 250 mg, 300 mg, 350 mg and 400 mg doses of the study drug. Participants will only be allowed to proceed to the next higher dose of GRT0151Y (or placebo) if the previous dose was well tolerated. Neither the participant nor the study staff will know whether participants are receiving GRT0151Y or placebo.

Conditions

Interventions

DRUG

GRT0151Y dose escalation

Single doses of 150, 200, 250, 300, 350 and 400 mg (3, 4, 5, 6, 7 or 8 capsules of 50 mg)

DRUG

Matching placebo

Matching placebo capsules (3, 4, 5, 6, 7 or 8 capsules)

Sponsors & Collaborators

  • Grünenthal GmbH

    lead INDUSTRY

Principal Investigators

  • Grünenthal Study Director · Grünenthal GmbH

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2006-01-20
Primary Completion
2006-03-02
Completion
2006-03-02

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 NCT03765658 on ClinicalTrials.gov