Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Arbaclofen Placarbil · 2 trials · 2 indications
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
Part of the pharmacokinetic profile of arbaclofen placarbil (AP) and R-baclofen in low dose arbaclofen placarbil modified release (MR) prototypes A and B.
| 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 |
| Part 1: Regimen A | EXPERIMENTAL | One low dose Arbaclofen Placarbil MR Prototype A tablet taken under fasting conditions. Part 1 participants receive Regimens A, B, C, D and E in a sequential manner. |
| Part 1: Regimen B | EXPERIMENTAL | One low dose Arbaclofen Placarbil MR Prototype B tablet taken under fasting conditions. Part 1 participants receive Regimens A, B, C, D and E in a sequential manner. |
| Part 1: Regimen C | ACTIVE_COMPARATOR | One low dose Arbaclofen Placarbil SR tablet taken under fasting conditions as the reference product. Part 1 participants receive Regimens A, B, C, D and E in a sequential manner. |
| Part 1: Regimen D | EXPERIMENTAL | One low dose tablet of the selected Arbaclofen Placarbil MR Prototype administered with 0.6 g/kg of beverage in orange juice. Part 1 participants receive Regimens A, B, C, D and E in a sequential manner. |
| Part 1: Regimen E | EXPERIMENTAL | An optional regimen of one low dose tablet of the selected Arbaclofen Placarbil MR Prototype administered with 0.6 g/kg of beverage in orange juice. Part 1 participants receive Regimens A, B, C, D and E in a sequential manner. |
| Part 2: Regimen F | EXPERIMENTAL | One low dose Arbaclofen Placarbil MR prototype tablet (selected based on review of the data in Part 1) taken under fasting conditions. Part 2 participants receive Regimens F, G, H, I and J in a sequential manner. |
| Part 2: Regimen G | ACTIVE_COMPARATOR | One low dose Arbaclofen Placarbil IR capsule taken under fasting conditions as the reference product. Part 2 participants receive Regimens F, G, H, I and J in a sequential manner. |
| Part 2: Regimen H | EXPERIMENTAL | One low dose Arbaclofen Placarbil MR prototype tablet (selected based on review of the data in Part 1) taken under fasting conditions. Part 2 participants receive Regimens F, G, H, I and J in a sequential manner. |
| Part 2: Regimen I | EXPERIMENTAL | One low dose Arbaclofen Placarbil MR prototype tablet (selected based on review of the data in Part 1) taken under fasting conditions. Part 2 participants receive Regimens F, G, H, I and J in a sequential manner. |
| Part 2: Regimen J | EXPERIMENTAL | One low dose Arbaclofen Placarbil MR prototype tablet (selected based on review of the data in Part 1) taken under fasting conditions, or a previously dosed MR prototype in the fed state. Part 2 participants receive Regimens F, G, H, I and J in a sequential manner. |
| Part 3: Regimen K | EXPERIMENTAL | One low dose selected Arbaclofen Placarbil MR prototype tablet (selected based on review of the data in Part 2) taken under fasting conditions. Part 3 participants receive Regimens K and L in a randomised crossover manner as the first two treatments, followed by Regimens M and N in a sequential manner. |
| Part 3: Regimen L | EXPERIMENTAL | One low dose selected Arbaclofen Placarbil MR prototype tablet administered with 0.6 g/kg of beverage in orange juice or in the fed state, or one mid-low dose of the selected Arbaclofen Placarbil MR prototype tablet. Part 3 participants receive Regimens K and L in a randomised crossover manner as the first two treatments, followed by Regimens M and N in a sequential manner. |
| Part 3: Regimen M | EXPERIMENTAL | An optional regimen of one mid-low dose of the selected Arbaclofen Placarbil MR prototype tablet (if not previously dosed in Regimen L) or one mid-high dose of the selected Arbaclofen Placarbil MR prototype tablet taken under fasting conditions. Part 3 participants receive Regimens K and L in a randomised crossover manner as the first two treatments, followed by Regimens M and N in a sequential manner. |
| Part 3: Regimen N | EXPERIMENTAL | An optional regimen of one mid-high dose of the selected Arbaclofen Placarbil MR prototype tablet (if not previously dosed in Regimen M) or two mid-low dose of the selected Arbaclofen Placarbil MR prototype tablets. Part 3 participants receive Regimens K and L in a randomised crossover manner as the first two treatments, followed by Regimens M and N in a sequential manner. |
| Name | Type | Description |
|---|---|---|
| Arbaclofen Placarbil | DRUG | Arbaclofen Placarbil |
| Placebo | DRUG | Placebo matched tablets |
| Arbaclofen Placarbil SR | DRUG | One low dose oral tablet of Arbaclofen Placarbil sustained release (SR) in the fasted state. |
| Arbaclofen Placarbil MR Prototype A | DRUG | One low dose oral tablet pf Arbaclofen Placarbil modified release (MR) Prototype A in the fasted state; this formulation may also be tested with 0.6 g/kg beverage diluted in orange juice |
| Arbaclofen Placarbil MR Prototype B | DRUG | One low dose oral tablet of Arbaclofen Placarbil modified release (MR) Prototype B; this formulation may also be tested with 0.6 g/kg beverage diluted in orange juice |
| Arbaclofen Placarbil IR | DRUG | One low dose oral capsule of Arbaclofen Placarbil immediate release (IR) in the fasted state. |
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 an investigational small molecule being studied for Alcohol Use Disorder. It is also used in clinical trials involving healthy volunteers to assess the bioavailability of modified release formulations. The drug is in Phase 2 development for the alcohol use disorder indication.
Arbaclofen Placarbil is being developed by Indivior Pharmaceuticals, Inc., which trades under the ticker INDV. The company is conducting clinical trials to evaluate the drug's safety and tolerability in subjects with Alcohol Use Disorder.
Arbaclofen Placarbil is in Phase 2 clinical development for Alcohol Use Disorder. It has completed a Phase 2 dose-escalation study and a Phase 1 bioavailability study. The drug remains investigational and has not been approved by regulatory authorities.
Arbaclofen Placarbil has been studied in two completed trials. NCT02511886 was a Phase 2 dose-escalation study in 18 subjects with Alcohol Use Disorder in the United States. NCT03058237 was a Phase 1 bioavailability study in 40 healthy volunteers in the United Kingdom.
Arbaclofen Placarbil is not FDA approved. It is an investigational drug currently in clinical development for Alcohol Use Disorder. The completed trials include a Phase 2 study and a Phase 1 study, but the drug has not yet received marketing approval.