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
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|ClinicalTrials.gov Identifier: NCT03765658|
Recruitment Status : Completed
First Posted : December 5, 2018
Last Update Posted : December 5, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Pain Acute Pain Chronic Pain||Drug: GRT0151Y dose escalation Drug: Matching placebo||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||During each treatment period, participants randomly received either GRT0151Y or matching placebo, in a manner that no participant received placebo in two consecutive periods.|
|Masking:||Double (Participant, Investigator)|
|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|
|Actual Study Start Date :||January 20, 2006|
|Actual Primary Completion Date :||March 2, 2006|
|Actual Study Completion Date :||March 2, 2006|
Experimental: GRT0151Y dose escalation
GRT0151Y will be administered to participants as 50 mg capsules in a dose escalation range of 150, 200, 250, 300, 350 and 400 mg. Dose levels were increased by increments of 50 mg to a maximum of 400 mg, only after the previous dose level was found to be well-tolerated. During each treatment period, participants randomly received either GRT0151Y or matching placebo, in a manner that no participant received placebo in two consecutive periods.
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)
- Maximum Tolerated Dose (MTD) of GRT0151Y [ Time Frame: First dose to Last dose assessed to be well tolerated. From Day 1 to Day 3 (for up to 6 periods) ]The progression to the next higher dose group occurred only after a thorough risk-benefit assessment, based upon the safety and tolerability data of the participants from the completed trial group (interim safety report [ISR]). The ISRs were prepared by the investigator and were submitted to the sponsor for benefit-risk assessment. The MTD would have been reached if the benefit-risk assessment had been unfavorable to progress to the next higher dose group.
- Maximum observed plasma concentration (Cmax) of GRT0151Y [ Time Frame: pre-dose and 0.5, 1, 2, 4, 6, 8, 12, 24, 32 and 48 hours post dose ]Blood samples were obtained and plasma concentrations were determined using a validated stereoselective liquid chromatography-tandem mass spectrometry (LC-MS/MS).
- Time to reach maximum plasma concentration (tmax) of GRT0151Y [ Time Frame: pre-dose and 0.5, 1, 2, 4, 6, 8, 12, 24, 32 and 48 hours post dose ]Blood samples were obtained and plasma concentrations were determined using a validated stereoselective LC-MS/MS.
- Area under the plasma concentration-time curve (AUC0-t) [ Time Frame: pre-dose and 0.5, 1, 2, 4, 6, 8, 12, 24, 32 and 48 hours post dose ]Blood samples were obtained and plasma concentrations were determined using a validated stereoselective LC-MS/MS.
- Divided Attention Test (DAT) [ Time Frame: pre-dose, and 1, 2, 4, 6, 8, 12, 24, 32 and 48 hours post-dose ]Manual-tracking test with a simultaneous visual target detection component. Participant is provided with joystick and presented with the image of an airplane and a randomly curving road; participant has to position the airplane over the center of the road while being distracted repeatedly by visual targets they have to respond to. Percentage of time over the road (milliseconds), response latency of correct responses and percentage of target hits are recorded.
- Choice Reaction Time (CRT) [ Time Frame: pre-dose, and 1, 2, 4, 6, 8, 12, 24, 32 and 48 hours post-dose ]Choice reaction time (CRT) is a computerized assessment that trains the participant to respond to stimuli presented on the screen. The task requires the participant to react as soon as a colored key appears in one of up to eight locations. The participant must respond by lifting their finger from the central start button and depressing the corresponding response key as quickly as possible. This is the reaction time (RT). Lower scores indicate better performance.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03765658
|Ventana Clinical Research Corporation|
|Toronto, Ontario, Canada, M5V 2T3|
|Study Director:||Grünenthal Study Director||Grünenthal GmbH|