Pain Clinical Trial
Official title:
An Ascending Single-Dose Safety, Tolerability and Exposure Study to Explore the Maximum Tolerated Dose of GRT0151Y in Healthy Adult Non-dependent Recreational Opiate Users
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.
n/a
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