Trial · NCT02511886
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 21
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum Tolerated Dose (MTD) of Arbaclofen Placarbil | Up to 30 day residential (inpatient) treatment period | A data monitoring committee (DMC) will review and make a recommendation to stop dosing escalation based on the review of the unblinded AE and safety assessments or when at least one subject on active investigational product experiences an SAE related to the investigational product. The MTD and the dosage that will not be exceeded in the further development of this compound will be based upon a comprehensive review of the safety data. |
| Primary | Maximum Observed Plasma Concentration of Arbaclofen Placarbil (AP) (Cmax) | Prior to the initial dose of AP on day 1 and 0.5, 1, 2, 3, 4, 5, 6, 7, 8,10, 12, 16, 20, and 24 hours post-dose (predose day 2); and prior to dose of AP on days 6, 12, 18, and 24 and 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 hours post dose | Blood samples will be obtained and plasma concentrations determined using a validated liquid chromatography with tandem mass spectrometry methods |
| Primary | Time to Maximum Observed Plasma Concentration of Arbaclofen Placarbil (AP) (Tmax) | Prior to the initial dose of AP on day 1 and 0.5, 1, 2, 3, 4, 5, 6, 7, 8,10, 12, 16, 20, and 24 hours post-dose (predose day 2); and prior to dose of AP on days 6, 12, 18, and 24 and 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 hours post dose | Blood samples will be obtained and plasma concentrations determined using a validated liquid chromatography with tandem mass spectrometry methods |
| Primary | Area Under the Concentration -Time Curve from time 0 to the time of the last quantifiable plasma concentration (AUClast) | Prior to the initial dose of AP on day 1 and 0.5, 1, 2, 3, 4, 5, 6, 7, 8,10, 12, 16, 20 hours post dose | Blood samples will be obtained and plasma concentrations determined using a validated liquid chromatography with tandem mass spectrometry methods |
| Primary | Area Under the Concentration -Time Curve from time 0 extrapolated to infinite time (AUCinf) | Prior to the initial dose of AP on day 1 and 0.5, 1, 2, 3, 4, 5, 6, 7, 8,10, 12, 16, 20 hours post dose | Blood samples will be obtained and plasma concentrations determined using a validated liquid chromatography with tandem mass spectrometry methods |
| Primary | Area Under the Concentration -Time Curve from time 0 to 12 hours post dose(AUC0-12) | Prior to the initial dose of AP on day 1 and 0.5, 1, 2, 3, 4, 5, 6, 7, 8,10, 12, 16, 20 hours post dose | Blood samples will be obtained and plasma concentrations determined using a validated liquid chromatography with tandem mass spectrometry methods |
| Primary | Apparent Terminal Plasma Half-Life (t 1/2) | Prior to the initial dose of AP on day 1 and 0.5, 1, 2, 3, 4, 5, 6, 7, 8,10, 12, 16, 20 hours post | Blood samples will be obtained and plasma concentrations determined using a validated liquid chromatography with tandem mass spectrometry methods |
| Primary | Apparent Terminal Phase Rate Constant | Prior to the initial dose of AP on day 1 and 0.5, 1, 2, 3, 4, 5, 6, 7, 8,10, 12, 16, 20 hours post dose | Apparent terminal rate constant (1/h), determined by linear regression of the terminal points of the log-linear concentration-time curve. Visual assessment will be used to identify the terminal linear phase of the concentration-time profile. A minimum of 3 data points will be used for determination. |
| Primary | Percentage of AUCinf obtained by extrapolation (%AUCex) | Prior to the initial dose of AP on day 1 and 0.5, 1, 2, 3, 4, 5, 6, 7, 8,10, 12, 16, 20 hours post dose | If the extrapolated area is greater than 20% of AUCinf, then AUCinf will be listed but not included in summary presentations or statistical analyses |
| Primary | Apparent Oral Clearance (CL/F) | Prior to the initial dose of AP on day 1, 6, 12, 18, 24 and 0.5, 1, 2, 3, 4, 5, 6, 7, 8,10, 12, 16, 20 hours post dose | Calculated as Dose/AUCinf |
| Primary | Apparent Volume of Distribution (Vz/F) | Prior to the initial dose of AP on day 1 and 0.5, 1, 2, 3, 4, 5, 6, 7, 8,10, 12, 16, 20 hours post dose | Calculated as Dose/apparent terminal phase rate constant \* AUCinf |
| Primary | Area Under the Plasma Concentration-Time Curve From Time Zero To The End of Dosing Interval (AUCtau) | Prior to dose of AP on days 6, 12, 18, and 24 and 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 hours post dose | Area Under the Plasma Concentration-Time Curve From Time 0 to the End of the Dosing Interval |
| Primary | Minimum Observed Plasma Concentration (Cmin) | Prior to dose of AP on days 6, 12, 18, and 24 and 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 hours post dose | Blood samples will be obtained and plasma concentrations determined using a validated liquid chromatography with tandem mass spectrometry methods |
| Primary | Pre-Dose Plasma Concentration (Ctrough) | Prior to dose of AP on days 6, 12, 18, 19, 20, 21, 22, 23, and 24 hours post dose | Blood samples will be obtained and plasma concentrations determined using a validated liquid chromatography with tandem mass spectrometry methods |
| Secondary | The Number of Participants Who Experienced Serious or Non-Serious Adverse Events | Up to 11 weeks | A non-serious adverse event is any untoward medical occurrence. A serious adverse event is any adverse event that meets one or more of the following: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is a medically important event, as defined in the protocol |
| Secondary | Columbia Suicide Severity Rating Scale (C-SSRS) | Up to 11 weeks | All events of suicide-related behavior will be carefully monitored. These include emergence or significant worsening of reported suicidal ideation, plans, suicide attempts, and completed suicides. The C-SSRS will be used by the Investigator in the assessment of suicide risk. |
| Secondary | The Obsessive-Compulsive Drinking Scale (OCDS) | Up to 11 weeks | All continuous outcome measures including time to event endpoints collected will be summarized using descriptive statistics (n, mean, standard deviation (SD), median, min, and max). Categorial variables will be summarized using frequencies. |
| Secondary | Hospital Anxiety and Depression Scale (HADS) | Up to 11 weeks | The HADS is a 14-item scale that generates original data. Seven f the items relate to anxiety and 7 relate to depressive symptoms. Zigmond and Snaith created this outcome measure specifically to avoid reliance on aspects of these conditions that are also common somatic symptoms of illness; eg, fatigue, insomnia, or hypersomnia |
| Secondary | Alcohol Liver Biomarkers (Carbohydrate Deficient Transferrin and Gamma Glutamyl Transferase | Up to 11 weeks | Blood samples will be collected and sent to the central laboratory. |
| Secondary | Timeline Follow Back (TLFB) Interview for Cigarette and Alcohol Use | Up to 11 weeks | The TLFB interview is a method to assess recent alcohol use and will be administered by an interviewer to estimate retrospectively their alcohol use (frequency and number of drinks consumed) |
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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