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| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
| Intercept Pharmaceuticals | INDUSTRY |
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The main purpose of this study is to see whether heavy drinking will interfere with a specific pathway, called FXR signaling in the liver. The abnormality of this pathway may lead to liver injury in some patients who drink heavily.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Heavy Drinkers on placebo |
|
| 10 mg Obeticholic Acid (OCA) | Experimental | 10 mg Obeticholic Acid (OCA) Study medication will be administered orally, once daily for 4 weeks. |
|
| Non-drinking Controls | No Intervention | Non-drinking healthy controls |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | 1 tablet of placebo, taken orally daily with water, approximately 30 minutes prior to breakfast for 4 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Bile Salt Metabolism (C4 )Levels to Determine Effect of FXR | Baseline to 28 days | |
| Change in FGF19 Levels to Determine Effect of FXR | Baseline to 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Fasting Serum Bile Salt Levels | Baseline to 28 days | |
| Change in Oxidative Stress Level by Measuring Malondialdehyde | Baseline to 28 days | |
| Change in CYP2E1 Activity by Measuring Chlorzoxazone Clearance |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Suthat Liangpunsakul, MD | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University | Indianapolis | Indiana | 46202 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Heavy Drinkers on placebo Placebo: 1 tablet of placebo, taken orally daily with water, approximately 30 minutes prior to breakfast for 4 weeks. |
| FG001 | 10 mg Obeticholic Acid (OCA) | 10 mg Obeticholic Acid (OCA) Study medication will be administered orally, once daily for 4 weeks. 10 mg Obeticholic Acid (OCA): 10 mg Obeticholic Acid (OCA) Study medication will be administered orally, once daily, approximately 30 minutes prior to breakfast for 4 weeks. |
| FG002 | Non-drinking Controls | Non-drinking healthy controls |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Heavy Drinkers on placebo Placebo: 1 tablet of placebo, taken orally daily with water, approximately 30 minutes prior to breakfast for 4 weeks. |
| BG001 | 10 mg Obeticholic Acid (OCA) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Bile Salt Metabolism (C4 )Levels to Determine Effect of FXR | Zero participants were analyzed due to data not being collected | Posted | Baseline to 28 days |
|
Approximately 2.5 Months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Heavy Drinkers on placebo Placebo: 1 tablet of placebo, taken orally daily with water, approximately 30 minutes prior to breakfast for 4 weeks. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Suthat Liangpunsakul | IU School of Medicine | (317) 988-3232 | sliangpu@iu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 22, 2020 | Feb 21, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000428 | Alcohol Drinking |
| ID | Term |
|---|---|
| D004327 | Drinking Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| C464660 | obeticholic acid |
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| 10 mg Obeticholic Acid (OCA) | Drug | 10 mg Obeticholic Acid (OCA) Study medication will be administered orally, once daily, approximately 30 minutes prior to breakfast for 4 weeks. |
|
| Baseline to 28 days |
| Change in Gut Permeability Through Lactulose/Mannitol Test | This is the measurement to quantify two non-metabolized sugar molecules-lactulose and mannitol-to determine the gut permeability | Baseline to 28 days |
| Change in Bacterial Translocation Through Measures of Plasma LPS | Baseline to 28 days |
| Change in Intestinal Inflammation by Measuring Stool Calprotectin | Baseline to 28 days |
| Change in Activation of Innate Immunity Through Measures of TNF-alpha | Baseline to 28 days |
| Change in Bacterial Translocation Through Measures of Serum sCD14 | Baseline to 28 days |
| Change in Activation of Innate Immunity Through Measures of IL-6 | Baseline to 28 days |
| Change in Activation of Innate Immunity Through Measures of IL-8 | Baseline to 28 days |
| Change in Activation of Innate Immunity Through Measures of IL-1 | Baseline to 28 days |
10 mg Obeticholic Acid (OCA) Study medication will be administered orally, once daily for 4 weeks.
10 mg Obeticholic Acid (OCA): 10 mg Obeticholic Acid (OCA) Study medication will be administered orally, once daily, approximately 30 minutes prior to breakfast for 4 weeks.
| BG002 | Non-drinking Controls | Non-drinking healthy controls |
| BG003 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | Non-drinking Controls | Non-drinking healthy controls |
|
| Primary | Change in FGF19 Levels to Determine Effect of FXR | Zero participants were analyzed due to data not being collected | Posted | Baseline to 28 days |
|
|
| Secondary | Change in Fasting Serum Bile Salt Levels | Zero participants were analyzed due to data not being collected | Posted | Baseline to 28 days |
|
|
| Secondary | Change in Oxidative Stress Level by Measuring Malondialdehyde | Due to errors, some results were unable to be processed causing differences in the baseline and day 28. | Posted | Mean | Standard Deviation | µg/ml | Baseline to 28 days |
|
|
|
| Secondary | Change in CYP2E1 Activity by Measuring Chlorzoxazone Clearance | Zero participants were analyzed due to data not being collected | Posted | Baseline to 28 days |
|
|
| Secondary | Change in Gut Permeability Through Lactulose/Mannitol Test | This is the measurement to quantify two non-metabolized sugar molecules-lactulose and mannitol-to determine the gut permeability | Due to errors, some results were unable to be processed causing differences in the baseline and day 28. | Posted | Mean | Standard Deviation | lactulose/mannitol ratio | Baseline to 28 days |
|
|
|
| Secondary | Change in Bacterial Translocation Through Measures of Plasma LPS | Due to errors, some results were unable to be processed causing differences in the baseline and day 28. | Posted | Mean | Standard Deviation | Pg/ml | Baseline to 28 days |
|
|
|
| Secondary | Change in Intestinal Inflammation by Measuring Stool Calprotectin | Zero participants were analyzed due to data not being collected | Posted | Baseline to 28 days |
|
|
| Secondary | Change in Activation of Innate Immunity Through Measures of TNF-alpha | Due to errors, some results were unable to be processed causing differences in the baseline and day 28. | Posted | Mean | Standard Deviation | Pg/ml | Baseline to 28 days |
|
|
|
| Secondary | Change in Bacterial Translocation Through Measures of Serum sCD14 | Due to errors, some results were unable to be processed causing differences in the baseline and day 28. | Posted | Mean | Standard Deviation | µg/ml | Baseline to 28 days |
|
|
|
| Secondary | Change in Activation of Innate Immunity Through Measures of IL-6 | Zero participants were analyzed due to data not being collected | Posted | Baseline to 28 days |
|
|
| Secondary | Change in Activation of Innate Immunity Through Measures of IL-8 | Zero participants were analyzed due to data not being collected | Posted | Baseline to 28 days |
|
|
| Secondary | Change in Activation of Innate Immunity Through Measures of IL-1 | Due to errors, some results were unable to be processed causing differences in the baseline and day 28. | Posted | Mean | Standard Deviation | Pg/ml | Baseline to 28 days |
|
|
|
| 0 |
| 9 |
| 0 |
| 9 |
| 4 |
| 9 |
| EG001 | 10 mg Obeticholic Acid (OCA) | 10 mg Obeticholic Acid (OCA) Study medication will be administered orally, once daily for 4 weeks. 10 mg Obeticholic Acid (OCA): 10 mg Obeticholic Acid (OCA) Study medication will be administered orally, once daily, approximately 30 minutes prior to breakfast for 4 weeks. | 0 | 6 | 0 | 6 | 3 | 6 |
| EG002 | Non-drinking Controls | Non-drinking healthy controls | 0 | 15 | 0 | 15 | 0 | 15 |
| Headache | Nervous system disorders | Systematic Assessment |
|
| Burns first degree | Injury, poisoning and procedural complications | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| Thirst decreased | General disorders | Systematic Assessment |
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| Gastrointestinal pain | Gastrointestinal disorders | Systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | Systematic Assessment |
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| Alanine aminotransferase increased | Investigations | Systematic Assessment |
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| throat irritation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Fatigue | General disorders | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | Systematic Assessment |
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| Day 28 |
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| Day 28 |
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| Day 28 |
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| Day 28 |
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| Day 28 |
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