Alcohol Use DisorderPhase 2NCT02511886
A Dose-Escalation Study to Determine the Maximum Tolerated Dose of Arbaclofen Placarbil in Subjects With Alcohol Use Disorder
A Phase 2 study testing Arbaclofen Placarbil in people with Alcohol Use Disorder, run by Indivior Inc. at 1 site in United States.
Trial summary
This study will determine the maximum tolerated dose (MTD) of arbaclofen placarbil (AP) in the treatment of subjects with Alcohol Use Disorder (AUD). For every two subjects receiving AP, one subject will receive placebo. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- Arbaclofen Placarbil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2015to Jan 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 to 65 years of age.
- Diagnosis of AUD confirmed by the Mini-International Neuropsychiatric Interview.
- 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 screening.
- Provide written informed consent prior to any study-specific procedures.
- Self-report of at least 2 heavy drinking days per week in each of the 4 weeks prior to the screening interview.
- Willing to abstain from drinking for the time he/she is participating in the study.
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- Able to identify at least 1 "locator" person to assist study staff in tracking the subject for the non-residential clinic days.
- Able to read, speak, and understand English and be willing to cooperate with study procedures.
- For female subjects, women of childbearing potential must have a negative pregnancy test prior to enrollment and must agree to use a medically acceptable means of contraception from screening through at least 3 months after the last dose of IMP. Male subjects with female partners of childbearing potential must agree to use medically acceptable contraception from informed consent through at least 3 months after the last dose of IMP. Male subjects must also agree not to donate sperm during the study and for 3 months after receiving the last dose of IMP (Investigational Medicinal Product).
Who cannot join
- Has present symptoms or history of any of the following disorders:
- Schizophrenia
- Schizoaffective Disorder
- Delusional Disorder
- Bipolar I Disorder
- Any mood disorder with psychotic features or any psychotic disorder
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- Anorexia Nervosa
- Bulimia Nervosa
- Post-Traumatic Stress Disorder that could interfere with the study
- Any Personality Disorder that could interfere with the study
- Current diagnosis of any substance use disorder, except for nicotine, cannabis (mild or moderate), or alcohol.
- Positive result for any prohibited medication.
- History of suicidal ideation within 30 days prior to providing written informed consent.
- History of seizures or delirium tremens.
- Intention to initiate or continue additional formal alcohol-related treatment, including pharmacotherapy, during the active treatment period.
- Have had inpatient treatment for a non-alcohol substance use disorder in the 12 weeks prior to informed consent.
- Total bilirubin >1.5× the upper limit of normal (ULN), alanine aminotransferase (ALT) >3×ULN, aspartate aminotransferase (AST) >3×ULN, serum creatinine >2×ULN, international normalized ratio (INR) >1.5×ULN, lipase >3×ULN, amylase >3×ULN, or any abnormal pancreatic enzyme value above ULN that is associated with clinically significant active pancreatic disorder.
- Creatinine clearance of <80 mL/min, as calculated according to the Cockcroft-Gault equation.
- Hemoglobin at screening of <11.5 g/dL (for females) or <12.5 g/dL (for males).
- Body mass index (BMI) >30.
- Diagnosed with unstable medical disorders that could increase the potential risk of study treatment or interfere with study participation, including the following:
- Abnormal cardiac conditions, including:
- Uncontrolled hypertension.
- History of myocardial infarction in the last year or any prior history of myocardial infarction with active complication.
- Syncopal event within the past year.
- Congestive heart failure.
- Angina pectoris.
- QTcF (QT Fridericia-corrected) ≥450 msec for males and ≥470 msec for females at screening or randomization.
- Clinically significant abnormal finding on the physical exam or 12-lead ECG.
- Diabetes mellitus (type 1 or 2) fulfilling any of the following criteria:
- Glycosylated hemoglobin (HbA1c) >7.5% at screening.
- Uncontrolled diabetes mellitus.
- Have any other clinically significant abnormal laboratory result
- Must not have donated blood or have had any therapeutic phlebotomy (in an amount >300 mL) or received blood transfusion within 90 days preceding enrollment.
- Must not have a history of surgical procedures involving the brain or meninges, encephalitis, meningitis, degenerative central nervous system disorder (eg, Alzheimer's or Parkinson's Disease), epilepsy, mental retardation, or any other disease/procedure/accident/intervention associated with significant injury to or malfunction of the central nervous system (CNS), or a history of significant head trauma within the past 2 years, or currently receiving anticonvulsant therapy for any reason.
- Must not have acquired immunodeficiency syndrome (AIDS).
- Have any other active medical condition or organ disease that may either compromise subject safety or interfere with the safety and/or outcome evaluation of the IMP.
- History or presence of allergic or adverse response (including rash or anaphylaxis) to baclofen or any ingredient of the IMP.
- Have used baclofen within 30 days prior to informed consent.
- Taking medications which may be expected to significantly interfere with the metabolism or excretion of AP, may be associated with a significant drug interaction with AP, or may pose a significant risk to the subject's participation in the study.
- Participation in an interventional clinical study within 30 days prior to informed consent.
- Use of exclusionary drugs (e.g. antipsychotics, anticonvulsants, benzodiazepines, naltrexone, acamprosate).
- Site staff or subjects affiliated with, or a family member of, site staff directly involved in the study.
- Be unable to comply fully with the study requirements.
Trial locations and contacts
1 site in 1 country.
United States1 site
Research Centers of America
Oakland Park, Florida, 33334
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Determine the Maximum Tolerated Dose of Arbaclofen Placarbil in Subjects With Alcohol Use Disorder
This study will determine the maximum tolerated dose (MTD) of arbaclofen placarbil (AP) in the treatment of subjects with Alcohol Use Disorder (AUD). For every two subjects receiving AP, one subject will receive placebo.
Read the detailed description
This is a randomized, double-blind, placebo-controlled dose-escalation study to determine the MTD of AP in subjects with AUD. Eighteen (18) subjects will be randomized to receive either AP or placebo in a 2:1 ratio; ie, 12 subjects will be assigned to AP and 6 will be assigned to placebo. Efforts will be made to enroll all subjects in the same period of time at one clinical center. The expected maximum duration of participation for each subject is 11 weeks and will consist of up to a 3-week screening period, up to a 30-day residential (inpatient) treatment period, up to a 4-week non-residential (outpatient) treatment period, and an end of study / early termination clinic visit.
- Conditions
- Alcohol Use Disorder
- Being tested
- Arbaclofen Placarbil, Placebo
- Keywords
- Alcoholism, Alcohol Abuse, Alcohol Addiction, Alcohol Dependence, Alcohol Induced Disorders, Alcoholic Intoxication
- Medical subject headings
- Alcoholism, Alcohol-Induced Disorders, Alcoholic Intoxication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arbaclofen PlacarbilDrug
Arbaclofen Placarbil
PlaceboDrug
Also called Sugar Pill
Placebo matched tablets
| Study group | Role | What they receive |
|---|---|---|
| Arbaclofen Placarbil (AP) | Experimental | Orally administered Arbaclofen Placarbil (AP) sustained release (SR) tablets Receives: Drug: Arbaclofen Placarbil |
| Placebo | Placebo comparator | Subjects remain on placebo for entire study Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD) of Arbaclofen Placarbil
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.
Measured: Up to 30 day residential (inpatient) treatment period
Maximum Observed Plasma Concentration of Arbaclofen Placarbil (AP) (Cmax)
Blood samples will be obtained and plasma concentrations determined using a validated liquid chromatography with tandem mass spectrometry methods
Measured: 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
Time to Maximum Observed Plasma Concentration of Arbaclofen Placarbil (AP) (Tmax)
Blood samples will be obtained and plasma concentrations determined using a validated liquid chromatography with tandem mass spectrometry methods
Measured: 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
Area Under the Concentration -Time Curve from time 0 to the time of the last quantifiable plasma concentration (AUClast)
Blood samples will be obtained and plasma concentrations determined using a validated liquid chromatography with tandem mass spectrometry methods
Measured: 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
Area Under the Concentration -Time Curve from time 0 extrapolated to infinite time (AUCinf)
Blood samples will be obtained and plasma concentrations determined using a validated liquid chromatography with tandem mass spectrometry methods
Measured: 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
Area Under the Concentration -Time Curve from time 0 to 12 hours post dose(AUC0-12)
Blood samples will be obtained and plasma concentrations determined using a validated liquid chromatography with tandem mass spectrometry methods
Measured: 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 Plasma Half-Life (t 1/2)
Blood samples will be obtained and plasma concentrations determined using a validated liquid chromatography with tandem mass spectrometry methods
Measured: 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
Apparent Terminal Phase Rate Constant
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.
Measured: 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
Percentage of AUCinf obtained by extrapolation (%AUCex)
If the extrapolated area is greater than 20% of AUCinf, then AUCinf will be listed but not included in summary presentations or statistical analyses
Measured: 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 Oral Clearance (CL/F)
Calculated as Dose/AUCinf
Measured: 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
Apparent Volume of Distribution (Vz/F)
Calculated as Dose/apparent terminal phase rate constant * AUCinf
Measured: 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
Area Under the Plasma Concentration-Time Curve From Time Zero To The End of Dosing Interval (AUCtau)
Area Under the Plasma Concentration-Time Curve From Time 0 to the End of the Dosing Interval
Measured: 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
Minimum Observed Plasma Concentration (Cmin)
Blood samples will be obtained and plasma concentrations determined using a validated liquid chromatography with tandem mass spectrometry methods
Measured: 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
Pre-Dose Plasma Concentration (Ctrough)
Blood samples will be obtained and plasma concentrations determined using a validated liquid chromatography with tandem mass spectrometry methods
Measured: Prior to dose of AP on days 6, 12, 18, 19, 20, 21, 22, 23, and 24 hours post dose
Secondary outcomes (7)
The Number of Participants Who Experienced Serious or Non-Serious Adverse Events
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
Measured: Up to 11 weeks
Columbia Suicide Severity Rating Scale (C-SSRS)
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.
Measured: Up to 11 weeks
The Obsessive-Compulsive Drinking Scale (OCDS)
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.
Measured: Up to 11 weeks
Hospital Anxiety and Depression Scale (HADS)
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
Measured: Up to 11 weeks
Alcohol Liver Biomarkers (Carbohydrate Deficient Transferrin and Gamma Glutamyl Transferase
Blood samples will be collected and sent to the central laboratory.
Measured: Up to 11 weeks
Timeline Follow Back (TLFB) Interview for Cigarette and Alcohol Use
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)
Measured: Up to 11 weeks
Short Inventory of Problems-Revised (SIP-R)
The SIP-R is a 17 item self-reported inventory of adverse consequences associated with drug and alcohol use developed by Blanchard (2003). The SIP instructs participants to indicate how often each of the listed consequences has occurred during the past month on a 4-point scale (0-3). Item responses are summed to produce a total score and 5 subscale scores
Measured: Up to 11 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2015 (estimated)
- Study startSep 2015
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indivior Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Development Manager, Study director, Indivior Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02511886
- Sponsor's protocol ID
- RB-US-14-0001
- Status last verified
- Jan 2017
- First submitted
- 24 Jul 2015
- Last updated
- 23 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Determine the Maximum Tolerated Dose of Arbaclofen Placarbil in Subjects With Alcohol Use Disorder
- ClinicalTrials.gov ID
- NCT02511886
- Acronym / sponsor ID
- RB-US-14-0001
- Conditions
- Alcohol Use Disorder
- Keywords
- Alcoholism, Alcohol Abuse, Alcohol Addiction, Alcohol Dependence, Alcohol Induced Disorders, Alcoholic Intoxication
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Indivior Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2015 (actual)
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 30 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will determine the maximum tolerated dose (MTD) of arbaclofen placarbil (AP) in the treatment of subjects with Alcohol Use Disorder (AUD). For every two subjects receiving AP, one subject will receive placebo.
Detailed description
This is a randomized, double-blind, placebo-controlled dose-escalation study to determine the MTD of AP in subjects with AUD. Eighteen (18) subjects will be randomized to receive either AP or placebo in a 2:1 ratio; ie, 12 subjects will be assigned to AP and 6 will be assigned to placebo. Efforts will be made to enroll all subjects in the same period of time at one clinical center. The expected maximum duration of participation for each subject is 11 weeks and will consist of up to a 3-week screening period, up to a 30-day residential (inpatient) treatment period, up to a 4-week non-residential (outpatient) treatment period, and an end of study / early termination clinic visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arbaclofen Placarbil (AP) | Experimental | Drug: Arbaclofen PlacarbilOrally administered Arbaclofen Placarbil (AP) sustained release (SR) tablets |
| Placebo | Placebo comparator | Drug: PlaceboSubjects remain on placebo for entire study |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 18 to 65 years of age.
- Diagnosis of AUD confirmed by the Mini-International Neuropsychiatric Interview.
- 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 screening.
- Provide written informed consent prior to any study-specific procedures.
- Self-report of at least 2 heavy drinking days per week in each of the 4 weeks prior to the screening interview.
Key exclusion criteria (44 listed)
- Has present symptoms or history of any of the following disorders:
- Current diagnosis of any substance use disorder, except for nicotine, cannabis (mild or moderate), or alcohol.
- Positive result for any prohibited medication.
- History of suicidal ideation within 30 days prior to providing written informed consent.
- History of seizures or delirium tremens.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arbaclofen PlacarbilArbaclofen Placarbil | Drug | Arbaclofen Placarbil (AP) |
| PlaceboAlso: Sugar PillPlacebo matched tablets | Drug | Placebo |
Primary outcome
Maximum Tolerated Dose (MTD) of Arbaclofen Placarbil
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
7 secondary outcomes
The Number of Participants Who Experienced Serious or Non-Serious Adverse Events
Time frame: Up to 11 weeks
Columbia Suicide Severity Rating Scale (C-SSRS)
Time frame: Up to 11 weeks
The Obsessive-Compulsive Drinking Scale (OCDS)
Time frame: Up to 11 weeks
Hospital Anxiety and Depression Scale (HADS)
Time frame: Up to 11 weeks
Alcohol Liver Biomarkers (Carbohydrate Deficient Transferrin and Gamma Glutamyl Transferase
Time frame: Up to 11 weeks
Timeline Follow Back (TLFB) Interview for Cigarette and Alcohol Use
Time frame: Up to 11 weeks
Short Inventory of Problems-Revised (SIP-R)
Time frame: Up to 11 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Global Clinical Development Manager study director
Indivior Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Arbaclofen Placarbil in people with Alcohol Use Disorder, run by Indivior Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 44 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Tolerated Dose (MTD) of Arbaclofen Placarbil (time frame: Up to 30 day residential (inpatient) treatment period). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2017.