Trial · NCT00661141
Outcomes32
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 32
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Adverse Events (AEs), Serious AEs, and AEs Leading to Study Discontinuation | Study Day 0 through Study Visit Day 7 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Pharmacokinetics (PK) of 4-MP: Maximum Plasma Concentration (Cmax) | Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment | Modified Intent-to-Treat: participants who received any study medication or procedure and who received study assessments through Study Day 2. | ng/mL | MEAN |
| SECONDARY | PK of 4-MP: Dose-Normalized (DN) Cmax | Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment | (ng/mL)/mg | MEAN | |
| SECONDARY | PK of 4-MP: Time to Cmax (Tmax) | Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment | Modified Intent-to-Treat: participants who received any study medication or procedure and who received study assessments through Study Day 2. | hours | MEDIAN |
| SECONDARY | PK of 4-MP: Area Under the Plasma Concentration-Time Curve (AUC), Calculated to the Last Measured Concentration (AUC[0-t]) | Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment | Modified Intent-to-Treat: participants who received any study medication or procedure and who received study assessments through Study Day 2. | ng*hr/mL | MEAN |
| SECONDARY | PK of 4-MP: DN AUC(0-t) | Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment | Modified Intent-to-Treat: participants who received any study medication or procedure and who received study assessments through Study Day 2. | (ng*hr/mL)/mg | MEAN |
| SECONDARY | PK of 4-MP: AUC, From Time 0 Extrapolated to Infinite Time (AUC[0-∞]) | Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment | Modified Intent-to-Treat: participants who received any study medication or procedure, received study assessments through Study Day 2, and who had available data. | ng*hr/mL | MEAN |
| SECONDARY | PK of 4-MP: DN AUC(0-∞) | Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment | Modified Intent-to-Treat: participants who received any study medication or procedure, received study assessments through Study Day 2, and who had available data. | (ng*hr/mL)/mg | MEAN |
| SECONDARY | PK of 4-MP: Percentage of AUC0-∞ Obtained by Extrapolation (AUC%Extrap) | Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment | Modified Intent-to-Treat: participants who received any study medication or procedure, received study assessments through Study Day 2, and who had available data. | percentage | MEAN |
| SECONDARY | PK of 4-MP: Half-Life (T1/2) | Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment | Modified Intent-to-Treat: participants who received any study medication or procedure, received study assessments through Study Day 2, and who had available data. | hours | MEAN |
| SECONDARY | PK of 4-MP: Apparent Clearance (CL/F) | Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment | Modified Intent-to-Treat: participants who received any study medication or procedure, received study assessments through Study Day 2, and who had available data. | L/hr | MEAN |
| SECONDARY | PK of 4-MP: Apparent Volume of Distribution During Terminal Phase (Vz/F) | Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment | Modified Intent-to-Treat: participants who received any study medication or procedure, received study assessments through Study Day 2, and who had available data. | Liters | MEAN |
| SECONDARY | PK of Ethanol: Cmax | Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment | Modified Intent-to-Treat: participants who received any study medication or procedure and who received study assessments through Study Day 2. | mg/dL | MEAN |
| SECONDARY | PK of Ethanol: DN Cmax | Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment | Modified Intent-to-Treat: participants who received any study medication or procedure and who received study assessments through Study Day 2. | (mg/dL)/mg | MEAN |
| SECONDARY | PK of Ethanol: Tmax | Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment | Modified Intent-to-Treat: participants who received any study medication or procedure and who received study assessments through Study Day 2. | hours | MEDIAN |
| SECONDARY | PK of Ethanol: AUC(0-t) | Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment | Modified Intent-to-Treat: participants who received any study medication or procedure and who received study assessments through Study Day 2. | mg*hr/dL | MEAN |
| SECONDARY | PK of Ethanol: DN AUC(0-t) | Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment | Modified Intent-to-Treat: participants who received any study medication or procedure and who received study assessments through Study Day 2. | (mg*hr/dL)/mg | MEAN |
| SECONDARY | PK of Ethanol: AUC(0-∞) | Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment | Modified Intent-to-Treat: participants who received any study medication or procedure and who received study assessments through Study Day 2. | mg*hr/mL | MEAN |
| SECONDARY | PK of Ethanol: DN AUC(0-∞) | Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment | Modified Intent-to-Treat: participants who received any study medication or procedure, received study assessments through Study Day 2, and who had available data. | (mg*hr/dL)/mg | MEAN |
| SECONDARY | PK of Ethanol: AUC%Extrap | Days 1 and 2: prior to administration of 1st treatment (ethanol or study drug); 10, 20, and 30 min prior to administration of second treatment (study drug or ethanol); 40, 50, 60 min and 2, 3, 4, 5, 6, and 8 hr post administration of 1st treatment | Modified Intent-to-Treat: participants who received any study medication or procedure, received study assessments through Study Day 2, and who had available data. | percentage | MEAN |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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