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Arbaclofen Placarbil

Phase 2

Alcohol Use Disorder | Small molecule | Other |Indivior Pharmaceuticals, Inc.|Last Updated: Jan 23, 2017

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment18
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02511886A Dose-Escalation Study to Determine the Maximum Tolerated Dose of Arbaclofen Placarbil in Subjects With Alcohol Use DisorderPHASE2 COMPLETED 18 — — Sep 1, 2015Jan 1, 2016Jan 23, 20171 United States
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Study Endpoints
Primary Endpoints
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.

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

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

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

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

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

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

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.

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

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

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

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

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

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 Endpoints
The Number of Participants Who Experienced Serious or Non-Serious Adverse Events
Up to 11 weeks
Columbia Suicide Severity Rating Scale (C-SSRS)
Up to 11 weeks
The Obsessive-Compulsive Drinking Scale (OCDS)
Up to 11 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Arbaclofen Placarbil (AP)EXPERIMENTALOrally administered Arbaclofen Placarbil (AP) sustained release (SR) tablets
PlaceboPLACEBO_COMPARATORSubjects remain on placebo for entire study
Interventions
NameTypeDescription
Arbaclofen PlacarbilDRUGArbaclofen Placarbil
PlaceboDRUGPlacebo matched tablets
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites1

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 ...

Countries:United States
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