Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Arbaclofen Placarbil SR
Arbaclofen Placarbil · 1 trial · 1 indication
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.
Blood samples will be obtained and plasma concentrations determined using a validated liquid chromatography with tandem mass spectrometry methods
Blood samples will be obtained and plasma concentrations determined using a validated liquid chromatography with tandem mass spectrometry methods
Blood samples will be obtained and plasma concentrations determined using a validated liquid chromatography with tandem mass spectrometry methods
Blood samples will be obtained and plasma concentrations determined using a validated liquid chromatography with tandem mass spectrometry methods
Blood samples will be obtained and plasma concentrations determined using a validated liquid chromatography with tandem mass spectrometry methods
Blood samples will be obtained and plasma concentrations determined using a validated liquid chromatography with tandem mass spectrometry methods
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.
If the extrapolated area is greater than 20% of AUCinf, then AUCinf will be listed but not included in summary presentations or statistical analyses
Calculated as Dose/AUCinf
Calculated as Dose/apparent terminal phase rate constant \* AUCinf
Area Under the Plasma Concentration-Time Curve From Time 0 to the End of the Dosing Interval
Blood samples will be obtained and plasma concentrations determined using a validated liquid chromatography with tandem mass spectrometry methods
Blood samples will be obtained and plasma concentrations determined using a validated liquid chromatography with tandem mass spectrometry methods
| Arm | Type | Description |
|---|---|---|
| Arbaclofen Placarbil (AP) | EXPERIMENTAL | Orally administered Arbaclofen Placarbil (AP) sustained release (SR) tablets |
| Placebo | PLACEBO_COMPARATOR | Subjects remain on placebo for entire study |
| Name | Type | Description |
|---|---|---|
| Arbaclofen Placarbil | DRUG | Arbaclofen Placarbil |
| Placebo | DRUG | Placebo matched tablets |
Inclusion Criteria: 1. 18 to 65 years of age. 2. Diagnosis of AUD confirmed by the Mini-International Neuropsychiatric Interview. 3. For those requiring medical detoxification from alcohol, subjects will be required to have completed a program for detoxification from alcohol within 4 days prior to ...
Arbaclofen Placarbil is being developed for the treatment of Alcohol Use Disorder. It is an investigational small molecule that has been studied in a Phase 2 clinical trial. The drug is not approved for any indication and remains in clinical development.
Arbaclofen Placarbil targets the GABBR1 and GABBR2 receptors, where it acts as an agonist. By activating these GABA-B receptors, it is thought to modulate neurotransmitter activity associated with alcohol dependence. This mechanism is being explored for its potential to reduce alcohol craving and consumption.
Arbaclofen Placarbil is being developed by Indivior Pharmaceuticals, Inc., which trades under the ticker symbol INDV. Indivior is a specialty pharmaceutical company focused on treatments for addiction and related conditions.
Arbaclofen Placarbil is in Phase 2 clinical development. A single Phase 2 trial has been completed, and no active trials are currently listed. The drug is investigational and has not been approved by the FDA for any indication.
Arbaclofen Placarbil has been evaluated in one completed Phase 2 trial, NCT02511886. This was a dose-escalation study to determine the maximum tolerated dose in subjects with Alcohol Use Disorder. The trial enrolled 18 participants in the United States and was randomized, double-blind, and placebo-controlled.
Yes, Arbaclofen Placarbil SR is an alternative name for Arbaclofen Placarbil. Both names refer to the same investigational drug candidate being developed by Indivior Pharmaceuticals for Alcohol Use Disorder.