Trial Outcomes & Findings for Effect of Heavy Alcohol Consumption on Farnesoid X Receptor (FXR) Signaling (NCT NCT02654236)
NCT ID: NCT02654236
Last Updated: 2023-04-25
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
30 participants
Primary outcome timeframe
Baseline to 28 days
Results posted on
2023-04-25
Participant Flow
Participant milestones
| Measure |
Placebo
Heavy Drinkers on placebo
Placebo: 1 tablet of placebo, taken orally daily with water, approximately 30 minutes prior to breakfast for 4 weeks.
|
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.
|
Non-drinking Controls
Non-drinking healthy controls
|
|---|---|---|---|
|
Overall Study
STARTED
|
9
|
6
|
15
|
|
Overall Study
COMPLETED
|
9
|
6
|
13
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
2
|
Reasons for withdrawal
| Measure |
Placebo
Heavy Drinkers on placebo
Placebo: 1 tablet of placebo, taken orally daily with water, approximately 30 minutes prior to breakfast for 4 weeks.
|
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.
|
Non-drinking Controls
Non-drinking healthy controls
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
2
|
Baseline Characteristics
Effect of Heavy Alcohol Consumption on Farnesoid X Receptor (FXR) Signaling
Baseline characteristics by cohort
| Measure |
Placebo
n=9 Participants
Heavy Drinkers on placebo
Placebo: 1 tablet of placebo, taken orally daily with water, approximately 30 minutes prior to breakfast for 4 weeks.
|
10 mg Obeticholic Acid (OCA)
n=6 Participants
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.
|
Non-drinking Controls
n=15 Participants
Non-drinking healthy controls
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
31 Years
n=5 Participants
|
49 Years
n=7 Participants
|
47 Years
n=5 Participants
|
39 Years
n=4 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=5 Participants
|
6 participants
n=7 Participants
|
15 participants
n=5 Participants
|
30 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline to 28 daysPopulation: Zero participants were analyzed due to data not being collected
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline to 28 daysPopulation: Zero participants were analyzed due to data not being collected
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to 28 daysPopulation: Zero participants were analyzed due to data not being collected
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to 28 daysPopulation: Due to errors, some results were unable to be processed causing differences in the baseline and day 28.
Outcome measures
| Measure |
Placebo
n=9 Participants
Heavy Drinkers on placebo
Placebo: 1 tablet of placebo, taken orally daily with water, approximately 30 minutes prior to breakfast for 4 weeks.
|
10 mg Obeticholic Acid (OCA)
n=6 Participants
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.
|
Non-drinking Controls
n=15 Participants
Non-drinking healthy controls
|
|---|---|---|---|
|
Change in Oxidative Stress Level by Measuring Malondialdehyde
Baseline
|
2.56 µg/ml
Standard Deviation 0.79
|
2.79 µg/ml
Standard Deviation 3.44
|
1.03 µg/ml
Standard Deviation 1.46
|
|
Change in Oxidative Stress Level by Measuring Malondialdehyde
Day 28
|
1.54 µg/ml
Standard Deviation 1.77
|
3.30 µg/ml
Standard Deviation 4.03
|
1.38 µg/ml
Standard Deviation 0.58
|
SECONDARY outcome
Timeframe: Baseline to 28 daysPopulation: Zero participants were analyzed due to data not being collected
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to 28 daysPopulation: Due to errors, some results were unable to be processed causing differences in the baseline and day 28.
This is the measurement to quantify two non-metabolized sugar molecules-lactulose and mannitol-to determine the gut permeability
Outcome measures
| Measure |
Placebo
n=8 Participants
Heavy Drinkers on placebo
Placebo: 1 tablet of placebo, taken orally daily with water, approximately 30 minutes prior to breakfast for 4 weeks.
|
10 mg Obeticholic Acid (OCA)
n=6 Participants
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.
|
Non-drinking Controls
n=12 Participants
Non-drinking healthy controls
|
|---|---|---|---|
|
Change in Gut Permeability Through Lactulose/Mannitol Test
Day 28
|
0.05 lactulose/mannitol ratio
Standard Deviation 0.03
|
0.07 lactulose/mannitol ratio
Standard Deviation 0.05
|
0.05 lactulose/mannitol ratio
Standard Deviation 0.05
|
|
Change in Gut Permeability Through Lactulose/Mannitol Test
Baseline
|
0.05 lactulose/mannitol ratio
Standard Deviation 0.03
|
0.04 lactulose/mannitol ratio
Standard Deviation 0.01
|
0.04 lactulose/mannitol ratio
Standard Deviation 0.02
|
SECONDARY outcome
Timeframe: Baseline to 28 daysPopulation: Due to errors, some results were unable to be processed causing differences in the baseline and day 28.
Outcome measures
| Measure |
Placebo
n=9 Participants
Heavy Drinkers on placebo
Placebo: 1 tablet of placebo, taken orally daily with water, approximately 30 minutes prior to breakfast for 4 weeks.
|
10 mg Obeticholic Acid (OCA)
n=6 Participants
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.
|
Non-drinking Controls
n=15 Participants
Non-drinking healthy controls
|
|---|---|---|---|
|
Change in Bacterial Translocation Through Measures of Plasma LPS
Baseline
|
40.22 Pg/ml
Standard Deviation 9.52
|
58.73 Pg/ml
Standard Deviation 13.3
|
58.28 Pg/ml
Standard Deviation 28.8
|
|
Change in Bacterial Translocation Through Measures of Plasma LPS
Day 28
|
47.84 Pg/ml
Standard Deviation 23.1
|
47.0 Pg/ml
Standard Deviation 22.3
|
19.99 Pg/ml
Standard Deviation 16.93
|
SECONDARY outcome
Timeframe: Baseline to 28 daysPopulation: Zero participants were analyzed due to data not being collected
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to 28 daysPopulation: Due to errors, some results were unable to be processed causing differences in the baseline and day 28.
Outcome measures
| Measure |
Placebo
n=9 Participants
Heavy Drinkers on placebo
Placebo: 1 tablet of placebo, taken orally daily with water, approximately 30 minutes prior to breakfast for 4 weeks.
|
10 mg Obeticholic Acid (OCA)
n=6 Participants
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.
|
Non-drinking Controls
n=15 Participants
Non-drinking healthy controls
|
|---|---|---|---|
|
Change in Activation of Innate Immunity Through Measures of TNF-alpha
Baseline
|
6.53 Pg/ml
Standard Deviation 3.52
|
8.99 Pg/ml
Standard Deviation 4.39
|
6.91 Pg/ml
Standard Deviation 3.36
|
|
Change in Activation of Innate Immunity Through Measures of TNF-alpha
Day 28
|
6.36 Pg/ml
Standard Deviation 3.00
|
7.97 Pg/ml
Standard Deviation 4.08
|
2.89 Pg/ml
Standard Deviation 3.27
|
SECONDARY outcome
Timeframe: Baseline to 28 daysPopulation: Due to errors, some results were unable to be processed causing differences in the baseline and day 28.
Outcome measures
| Measure |
Placebo
n=9 Participants
Heavy Drinkers on placebo
Placebo: 1 tablet of placebo, taken orally daily with water, approximately 30 minutes prior to breakfast for 4 weeks.
|
10 mg Obeticholic Acid (OCA)
n=6 Participants
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.
|
Non-drinking Controls
n=15 Participants
Non-drinking healthy controls
|
|---|---|---|---|
|
Change in Bacterial Translocation Through Measures of Serum sCD14
Baseline
|
2.56 µg/ml
Standard Deviation 0.79
|
3.05 µg/ml
Standard Deviation 0.91
|
2.09 µg/ml
Standard Deviation 0.44
|
|
Change in Bacterial Translocation Through Measures of Serum sCD14
Day 28
|
2.28 µg/ml
Standard Deviation 0.68
|
2.28 µg/ml
Standard Deviation 0.57
|
1.38 µg/ml
Standard Deviation 0.58
|
SECONDARY outcome
Timeframe: Baseline to 28 daysPopulation: Zero participants were analyzed due to data not being collected
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to 28 daysPopulation: Zero participants were analyzed due to data not being collected
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to 28 daysPopulation: Due to errors, some results were unable to be processed causing differences in the baseline and day 28.
Outcome measures
| Measure |
Placebo
n=9 Participants
Heavy Drinkers on placebo
Placebo: 1 tablet of placebo, taken orally daily with water, approximately 30 minutes prior to breakfast for 4 weeks.
|
10 mg Obeticholic Acid (OCA)
n=6 Participants
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.
|
Non-drinking Controls
n=15 Participants
Non-drinking healthy controls
|
|---|---|---|---|
|
Change in Activation of Innate Immunity Through Measures of IL-1
Baseline
|
1.90 Pg/ml
Standard Deviation 0.28
|
1.78 Pg/ml
Standard Deviation 0.24
|
1.77 Pg/ml
Standard Deviation 0.56
|
|
Change in Activation of Innate Immunity Through Measures of IL-1
Day 28
|
1.76 Pg/ml
Standard Deviation 0.32
|
1.45 Pg/ml
Standard Deviation 0.78
|
1.07 Pg/ml
Standard Deviation 0.30
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
10 mg Obeticholic Acid (OCA)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Non-drinking Controls
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=9 participants at risk
Heavy Drinkers on placebo
Placebo: 1 tablet of placebo, taken orally daily with water, approximately 30 minutes prior to breakfast for 4 weeks.
|
10 mg Obeticholic Acid (OCA)
n=6 participants at risk
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.
|
Non-drinking Controls
n=15 participants at risk
Non-drinking healthy controls
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract congestion
|
0.00%
0/9 • Approximately 2.5 Months
|
16.7%
1/6 • Number of events 1 • Approximately 2.5 Months
|
0.00%
0/15 • Approximately 2.5 Months
|
|
Nervous system disorders
Headache
|
11.1%
1/9 • Number of events 1 • Approximately 2.5 Months
|
33.3%
2/6 • Number of events 2 • Approximately 2.5 Months
|
0.00%
0/15 • Approximately 2.5 Months
|
|
Injury, poisoning and procedural complications
Burns first degree
|
0.00%
0/9 • Approximately 2.5 Months
|
16.7%
1/6 • Number of events 1 • Approximately 2.5 Months
|
0.00%
0/15 • Approximately 2.5 Months
|
|
Gastrointestinal disorders
Nausea
|
11.1%
1/9 • Number of events 2 • Approximately 2.5 Months
|
16.7%
1/6 • Number of events 1 • Approximately 2.5 Months
|
0.00%
0/15 • Approximately 2.5 Months
|
|
Gastrointestinal disorders
Diarrhea
|
11.1%
1/9 • Number of events 1 • Approximately 2.5 Months
|
0.00%
0/6 • Approximately 2.5 Months
|
0.00%
0/15 • Approximately 2.5 Months
|
|
General disorders
Thirst decreased
|
11.1%
1/9 • Number of events 1 • Approximately 2.5 Months
|
0.00%
0/6 • Approximately 2.5 Months
|
0.00%
0/15 • Approximately 2.5 Months
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
11.1%
1/9 • Number of events 1 • Approximately 2.5 Months
|
0.00%
0/6 • Approximately 2.5 Months
|
0.00%
0/15 • Approximately 2.5 Months
|
|
Investigations
Aspartate aminotransferase increased
|
11.1%
1/9 • Number of events 1 • Approximately 2.5 Months
|
0.00%
0/6 • Approximately 2.5 Months
|
0.00%
0/15 • Approximately 2.5 Months
|
|
Investigations
Alanine aminotransferase increased
|
11.1%
1/9 • Number of events 1 • Approximately 2.5 Months
|
0.00%
0/6 • Approximately 2.5 Months
|
0.00%
0/15 • Approximately 2.5 Months
|
|
Respiratory, thoracic and mediastinal disorders
throat irritation
|
11.1%
1/9 • Number of events 1 • Approximately 2.5 Months
|
0.00%
0/6 • Approximately 2.5 Months
|
0.00%
0/15 • Approximately 2.5 Months
|
|
Gastrointestinal disorders
Vomiting
|
11.1%
1/9 • Number of events 2 • Approximately 2.5 Months
|
0.00%
0/6 • Approximately 2.5 Months
|
0.00%
0/15 • Approximately 2.5 Months
|
|
General disorders
Fatigue
|
11.1%
1/9 • Number of events 1 • Approximately 2.5 Months
|
0.00%
0/6 • Approximately 2.5 Months
|
0.00%
0/15 • Approximately 2.5 Months
|
|
Gastrointestinal disorders
Gastritis
|
11.1%
1/9 • Number of events 1 • Approximately 2.5 Months
|
0.00%
0/6 • Approximately 2.5 Months
|
0.00%
0/15 • Approximately 2.5 Months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place