Trial Outcomes & Findings for Eluxadoline Bile Acid Malabsorption (BAM) Study (NCT NCT03441581)
NCT ID: NCT03441581
Last Updated: 2021-05-19
Results Overview
Stool consistency was assessed using the BSFS where: 1=Separate hard lumps like nuts to 7=Watery. The score was recorded by the participant in an electronic diary (e-diary). The score for each day was averaged over the 4-week period. A negative change from Baseline indicates improvement.
COMPLETED
PHASE4
24 participants
Baseline (Day 1) to Week 4
2021-05-19
Participant Flow
Participant milestones
| Measure |
Eluxadoline 100 mg With BAM
IBS-D participants with evidence of Bile Acid Malabsorption (BAM) treated with eluxadoline 100 mg oral tablets twice daily (BID) with food for 4 weeks.
|
Eluxadoline 100 mg Without BAM
IBS-D participants without evidence of BAM treated with eluxadoline 100 mg oral tablets BID with food for 4 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
|
Overall Study
COMPLETED
|
12
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Eluxadoline Bile Acid Malabsorption (BAM) Study
Baseline characteristics by cohort
| Measure |
Eluxadoline 100 mg With BAM
n=12 Participants
IBS-D participants with evidence of Bile Acid Malabsorption (BAM) treated with eluxadoline 100 mg oral tablets twice daily (BID) with food for 4 weeks.
|
Eluxadoline 100 mg Without BAM
n=12 Participants
IBS-D participants without evidence of BAM treated with eluxadoline 100 mg oral tablets BID with food for 4 weeks.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
41.6 years
STANDARD_DEVIATION 6.07 • n=99 Participants
|
40.2 years
STANDARD_DEVIATION 13.72 • n=107 Participants
|
40.9 years
STANDARD_DEVIATION 10.40 • n=206 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1) to Week 4Population: Modified Intent-to-Treat (mITT) Population included of all participants in Enrolled Population with ≥ 1 postbaseline assessment for BSFS.
Stool consistency was assessed using the BSFS where: 1=Separate hard lumps like nuts to 7=Watery. The score was recorded by the participant in an electronic diary (e-diary). The score for each day was averaged over the 4-week period. A negative change from Baseline indicates improvement.
Outcome measures
| Measure |
Eluxadoline 100 mg With BAM
n=12 Participants
IBS-D participants with evidence of Bile Acid Malabsorption (BAM) treated with eluxadoline 100 mg oral tablets twice daily (BID) with food for 4 weeks.
|
Eluxadoline 100 mg Without BAM
n=12 Participants
IBS-D participants without evidence of BAM treated with eluxadoline 100 mg oral tablets BID with food for 4 weeks.
|
|---|---|---|
|
Change From Baseline in Average Bristol Stool Form Scale (BSFS) Score Over 4 Weeks of Treatment Period
Baseline
|
5.89 score on a scale
Standard Deviation 0.639
|
5.34 score on a scale
Standard Deviation 0.777
|
|
Change From Baseline in Average Bristol Stool Form Scale (BSFS) Score Over 4 Weeks of Treatment Period
Change From Baseline at Week 4
|
-1.25 score on a scale
Standard Deviation 0.914
|
-1.09 score on a scale
Standard Deviation 0.902
|
PRIMARY outcome
Timeframe: Baseline (Day 1) to Week 4Population: Safety Population included of all participants who received ≥ 1 dose of study treatment.
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A TEAE is an AE that occurs or worsens after receiving investigational study drug.
Outcome measures
| Measure |
Eluxadoline 100 mg With BAM
n=12 Participants
IBS-D participants with evidence of Bile Acid Malabsorption (BAM) treated with eluxadoline 100 mg oral tablets twice daily (BID) with food for 4 weeks.
|
Eluxadoline 100 mg Without BAM
n=12 Participants
IBS-D participants without evidence of BAM treated with eluxadoline 100 mg oral tablets BID with food for 4 weeks.
|
|---|---|---|
|
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)
|
91.7 percentage of participants
|
58.3 percentage of participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1) to Week 4Population: Safety Population included of all participants who received ≥ 1 dose of study treatment.
Laboratory tests included tests of Clinical Chemistry, Hematology, and Urinalysis. The investigator determined if the result was potentially clinically significant.
Outcome measures
| Measure |
Eluxadoline 100 mg With BAM
n=12 Participants
IBS-D participants with evidence of Bile Acid Malabsorption (BAM) treated with eluxadoline 100 mg oral tablets twice daily (BID) with food for 4 weeks.
|
Eluxadoline 100 mg Without BAM
n=12 Participants
IBS-D participants without evidence of BAM treated with eluxadoline 100 mg oral tablets BID with food for 4 weeks.
|
|---|---|---|
|
Number of Participants Who Experienced Potentially Clinically Significant Change in Laboratory Tests
|
0 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1) to Week 4Population: Safety Population included of all participants who received ≥ 1 dose of study treatment.
Vital signs assessments included: pulse, respiratory rate, and blood pressure (systolic and diastolic). The investigator determined if the result was potentially clinically significant.
Outcome measures
| Measure |
Eluxadoline 100 mg With BAM
n=12 Participants
IBS-D participants with evidence of Bile Acid Malabsorption (BAM) treated with eluxadoline 100 mg oral tablets twice daily (BID) with food for 4 weeks.
|
Eluxadoline 100 mg Without BAM
n=12 Participants
IBS-D participants without evidence of BAM treated with eluxadoline 100 mg oral tablets BID with food for 4 weeks.
|
|---|---|---|
|
Number of Participants Who Experienced Potentially Clinically Significant Change in Vital Signs
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1) to Week 4Population: Safety Population included of all participants who received ≥ 1 dose of study treatment.
General Physical Examination consisted of a full review of body systems excluding pelvic and rectal exams. The investigator determined if the result was clinically significant.
Outcome measures
| Measure |
Eluxadoline 100 mg With BAM
n=12 Participants
IBS-D participants with evidence of Bile Acid Malabsorption (BAM) treated with eluxadoline 100 mg oral tablets twice daily (BID) with food for 4 weeks.
|
Eluxadoline 100 mg Without BAM
n=12 Participants
IBS-D participants without evidence of BAM treated with eluxadoline 100 mg oral tablets BID with food for 4 weeks.
|
|---|---|---|
|
Number of Participants Who Experienced Clinically Significant Change From Baseline in General Physical Condition as Measured Through General Physical Exam
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1) to Week 4Population: mITT Population included of all participants in enrolled population with ≥ 1 postbaseline assessment for BSFS.
Bowel movements were recorded by the participant in an electronic diary (e-diary). The number of bowel movements per day was averaged over the 4-week period. A negative change from Baseline indicates improvement.
Outcome measures
| Measure |
Eluxadoline 100 mg With BAM
n=12 Participants
IBS-D participants with evidence of Bile Acid Malabsorption (BAM) treated with eluxadoline 100 mg oral tablets twice daily (BID) with food for 4 weeks.
|
Eluxadoline 100 mg Without BAM
n=12 Participants
IBS-D participants without evidence of BAM treated with eluxadoline 100 mg oral tablets BID with food for 4 weeks.
|
|---|---|---|
|
Change From Baseline in the 4-week Average of Daily Bowel Movement Frequency During the Treatment Period
Baseline
|
4.18 bowel movements per day
Standard Deviation 2.792
|
2.86 bowel movements per day
Standard Deviation 1.071
|
|
Change From Baseline in the 4-week Average of Daily Bowel Movement Frequency During the Treatment Period
Change from Baseline at Week 4
|
-1.48 bowel movements per day
Standard Deviation 1.509
|
-0.79 bowel movements per day
Standard Deviation 0.420
|
SECONDARY outcome
Timeframe: Baseline (Day 1) to Week 4Population: mITT Population included of all participants in enrolled population with ≥ 1 postbaseline assessment for BSFS.
The participant recorded their worst abdominal pain score in the past 24 hours each day in an e-diary where: 0=no pain to 10=worst imaginable pain. The score each day was averaged over the 4-week period. A negative change from Baseline indicates improvement.
Outcome measures
| Measure |
Eluxadoline 100 mg With BAM
n=12 Participants
IBS-D participants with evidence of Bile Acid Malabsorption (BAM) treated with eluxadoline 100 mg oral tablets twice daily (BID) with food for 4 weeks.
|
Eluxadoline 100 mg Without BAM
n=12 Participants
IBS-D participants without evidence of BAM treated with eluxadoline 100 mg oral tablets BID with food for 4 weeks.
|
|---|---|---|
|
Change From Baseline in the 4-week Average of Daily Worst Abdominal Pain Scores During the Treatment Period
Baseline
|
1.77 score on a scale
Standard Deviation 1.510
|
3.13 score on a scale
Standard Deviation 1.755
|
|
Change From Baseline in the 4-week Average of Daily Worst Abdominal Pain Scores During the Treatment Period
Change from Baseline at Week 4
|
-0.12 score on a scale
Standard Deviation 0.769
|
-1.28 score on a scale
Standard Deviation 1.004
|
SECONDARY outcome
Timeframe: Baseline (Day 1) to Week 4Population: mITT Population included of all participants in enrolled population with ≥ 1 postbaseline assessment for BSFS.
The participant recorded their bloating score in the past 24 hours each day in an e-diary where: 0=no bloating to 10=worst imaginable bloating. The score each day was averaged over the 4-week period. A negative change from Baseline indicates improvement.
Outcome measures
| Measure |
Eluxadoline 100 mg With BAM
n=12 Participants
IBS-D participants with evidence of Bile Acid Malabsorption (BAM) treated with eluxadoline 100 mg oral tablets twice daily (BID) with food for 4 weeks.
|
Eluxadoline 100 mg Without BAM
n=12 Participants
IBS-D participants without evidence of BAM treated with eluxadoline 100 mg oral tablets BID with food for 4 weeks.
|
|---|---|---|
|
Change From Baseline in the 4-week Average of Daily Bloating Scores During the Treatment Period
Baseline
|
2.31 score on a scale
Standard Deviation 2.291
|
4.07 score on a scale
Standard Deviation 2.496
|
|
Change From Baseline in the 4-week Average of Daily Bloating Scores During the Treatment Period
Change from Baseline at Week 4
|
-0.47 score on a scale
Standard Deviation 1.572
|
-1.46 score on a scale
Standard Deviation 1.297
|
SECONDARY outcome
Timeframe: Baseline (Day 1) to Week 4Population: mITT Population included of all participants in enrolled population with ≥ 1 postbaseline assessment for BSFS.
The participant recorded the number of urgent bowel movements in the past 24 hours each day in an e-diary. The number of urgent bowel movements per day was averaged over the 4-week period. A negative change from Baseline indicates improvement.
Outcome measures
| Measure |
Eluxadoline 100 mg With BAM
n=12 Participants
IBS-D participants with evidence of Bile Acid Malabsorption (BAM) treated with eluxadoline 100 mg oral tablets twice daily (BID) with food for 4 weeks.
|
Eluxadoline 100 mg Without BAM
n=12 Participants
IBS-D participants without evidence of BAM treated with eluxadoline 100 mg oral tablets BID with food for 4 weeks.
|
|---|---|---|
|
Change From Baseline in the 4-week Average Number of Daily Urgent Bowel Movements During the Treatment Period
Baseline
|
1.67 urgent bowel movements per day
Standard Deviation 1.179
|
1.22 urgent bowel movements per day
Standard Deviation 0.652
|
|
Change From Baseline in the 4-week Average Number of Daily Urgent Bowel Movements During the Treatment Period
Change from Baseline at Week 4
|
-0.52 urgent bowel movements per day
Standard Deviation 0.736
|
-0.80 urgent bowel movements per day
Standard Deviation 0.651
|
SECONDARY outcome
Timeframe: Baseline (Day 1) to Week 4Population: mITT Population included of all participants in enrolled population with ≥ 1 postbaseline assessment for BSFS.
The participant recorded the number of fecal incontinences in the past 24 hours each day in an e-diary. Fecal incontinence is the inability to control the passage of gas or stools. The number of fecal incontinences per day was averaged over the 4-week period. A negative change from Baseline indicates improvement.
Outcome measures
| Measure |
Eluxadoline 100 mg With BAM
n=12 Participants
IBS-D participants with evidence of Bile Acid Malabsorption (BAM) treated with eluxadoline 100 mg oral tablets twice daily (BID) with food for 4 weeks.
|
Eluxadoline 100 mg Without BAM
n=12 Participants
IBS-D participants without evidence of BAM treated with eluxadoline 100 mg oral tablets BID with food for 4 weeks.
|
|---|---|---|
|
Percentage of Participants With Any Fecal Incontinence During the Treatment Period
|
33.3 percentage of participants
|
33.3 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline (Day1) to End of Treatment (Up to Week 4)Population: mITT Population included of all participants in enrolled population with ≥ 1 postbaseline assessment for BSFS.
IBS-QOL is composed of 34 items about how the symptoms of IBS are impacting the participant's life scored on a 1 to 5 scale, where lower item scores indicate greater quality of life. The individual responses to the answered items were summed and standardized for a total score and then transformed to a 0 to 100-point scale (0=worst; 100=better) for ease of interpretation. A positive change from Baseline indicates improved quality of life.
Outcome measures
| Measure |
Eluxadoline 100 mg With BAM
n=12 Participants
IBS-D participants with evidence of Bile Acid Malabsorption (BAM) treated with eluxadoline 100 mg oral tablets twice daily (BID) with food for 4 weeks.
|
Eluxadoline 100 mg Without BAM
n=12 Participants
IBS-D participants without evidence of BAM treated with eluxadoline 100 mg oral tablets BID with food for 4 weeks.
|
|---|---|---|
|
Change From Baseline in Irritable Bowel Syndrome Quality of Life (IBS-QOL) Total Score at the End of the Treatment Period
Baseline
|
75.1 score on a scale
Standard Deviation 14.43
|
71.4 score on a scale
Standard Deviation 13.42
|
|
Change From Baseline in Irritable Bowel Syndrome Quality of Life (IBS-QOL) Total Score at the End of the Treatment Period
Change from Baseline at Week 4
|
8.8 score on a scale
Standard Deviation 11.70
|
13.2 score on a scale
Standard Deviation 10.63
|
SECONDARY outcome
Timeframe: Baseline (Day 1) to End of Treatment (Up to Week 4)Population: mITT Population included of all participants in enrolled population with ≥ 1 postbaseline assessment for BSFS. Number analyzed is the number of participants with data available for analyses.
Participants fasted for at least 8 hours prior to the test. Fasting serum 7αC4 level was measured at Baseline and End of Treatment to determine whether any changes occurred following treatment with eluxadoline. The negative change from Baseline indicates improvement.
Outcome measures
| Measure |
Eluxadoline 100 mg With BAM
n=12 Participants
IBS-D participants with evidence of Bile Acid Malabsorption (BAM) treated with eluxadoline 100 mg oral tablets twice daily (BID) with food for 4 weeks.
|
Eluxadoline 100 mg Without BAM
n=12 Participants
IBS-D participants without evidence of BAM treated with eluxadoline 100 mg oral tablets BID with food for 4 weeks.
|
|---|---|---|
|
Change From Baseline in Fasting Serum 7α-hydroxy-4-cholesten-3-one (7αC4) Levels at the End of the Treatment Period
Baseline
|
42.95 nanogram/milliliter (ng/mL)
Standard Deviation 27.259
|
30.58 nanogram/milliliter (ng/mL)
Standard Deviation 17.248
|
|
Change From Baseline in Fasting Serum 7α-hydroxy-4-cholesten-3-one (7αC4) Levels at the End of the Treatment Period
Change from Baseline at End of Treatment
|
-5.59 nanogram/milliliter (ng/mL)
Standard Deviation 32.841
|
-8.78 nanogram/milliliter (ng/mL)
Standard Deviation 12.050
|
SECONDARY outcome
Timeframe: Predose and at the intervals 1-2, 3-4 and 5-8 hours postdose at Week 2Population: Pharmacokinetic (PK) population included all participants in the enrolled population and whose dry blood sample (DBS) was collected.
Outcome measures
| Measure |
Eluxadoline 100 mg With BAM
n=12 Participants
IBS-D participants with evidence of Bile Acid Malabsorption (BAM) treated with eluxadoline 100 mg oral tablets twice daily (BID) with food for 4 weeks.
|
Eluxadoline 100 mg Without BAM
n=12 Participants
IBS-D participants without evidence of BAM treated with eluxadoline 100 mg oral tablets BID with food for 4 weeks.
|
|---|---|---|
|
Cmax: Maximum Concentration for Eluxadoline
|
1.40 ng/mL
Standard Deviation 1.34
|
0.91 ng/mL
Standard Deviation 0.80
|
SECONDARY outcome
Timeframe: Predose and at the intervals 1-2, 3-4 and 5-8 hours postdose at Week 2Population: PK population included all participants in the enrolled population and whose DBS was collected.
Outcome measures
| Measure |
Eluxadoline 100 mg With BAM
n=12 Participants
IBS-D participants with evidence of Bile Acid Malabsorption (BAM) treated with eluxadoline 100 mg oral tablets twice daily (BID) with food for 4 weeks.
|
Eluxadoline 100 mg Without BAM
n=12 Participants
IBS-D participants without evidence of BAM treated with eluxadoline 100 mg oral tablets BID with food for 4 weeks.
|
|---|---|---|
|
Cmin: Minimum Concentration for Eluxadoline
|
0.39 ng/mL
Standard Deviation 0.44
|
0.42 ng/mL
Standard Deviation 0.59
|
SECONDARY outcome
Timeframe: Predose and at the intervals 1-2, 3-4 and 5-8 hours postdose at Week 2Population: PK population included all participants in the enrolled population and whose DBS was collected.
Outcome measures
| Measure |
Eluxadoline 100 mg With BAM
n=12 Participants
IBS-D participants with evidence of Bile Acid Malabsorption (BAM) treated with eluxadoline 100 mg oral tablets twice daily (BID) with food for 4 weeks.
|
Eluxadoline 100 mg Without BAM
n=12 Participants
IBS-D participants without evidence of BAM treated with eluxadoline 100 mg oral tablets BID with food for 4 weeks.
|
|---|---|---|
|
AUC: Area Under the Concentration-time Curve During the Dosing Interval for Eluxadoline
|
9.22 nanogram* hour/milliliter (ng*h/mL)
Standard Deviation 8.46
|
7.75 nanogram* hour/milliliter (ng*h/mL)
Standard Deviation 8.48
|
SECONDARY outcome
Timeframe: Predose and at the intervals 1-2, 3-4 and 5-8 hours postdose at Week 2Population: PK population included all participants in the enrolled population and whose DBS was collected.
Outcome measures
| Measure |
Eluxadoline 100 mg With BAM
n=12 Participants
IBS-D participants with evidence of Bile Acid Malabsorption (BAM) treated with eluxadoline 100 mg oral tablets twice daily (BID) with food for 4 weeks.
|
Eluxadoline 100 mg Without BAM
n=12 Participants
IBS-D participants without evidence of BAM treated with eluxadoline 100 mg oral tablets BID with food for 4 weeks.
|
|---|---|---|
|
Tmax: Time to Cmax for Eluxadoline
|
1.5 hours (h)
Interval 1.0 to 2.5
|
2.0 hours (h)
Interval 1.0 to 3.0
|
SECONDARY outcome
Timeframe: Predose and at the intervals 1-2, 3-4 and 5-8 hours postdose at Week 2Population: PK population included all participants in the enrolled population and whose DBS was collected.
Outcome measures
| Measure |
Eluxadoline 100 mg With BAM
n=12 Participants
IBS-D participants with evidence of Bile Acid Malabsorption (BAM) treated with eluxadoline 100 mg oral tablets twice daily (BID) with food for 4 weeks.
|
Eluxadoline 100 mg Without BAM
n=12 Participants
IBS-D participants without evidence of BAM treated with eluxadoline 100 mg oral tablets BID with food for 4 weeks.
|
|---|---|---|
|
t1/2: Half-Life for Eluxadoline
|
30.5 h
Interval 24.7 to 58.1
|
35.2 h
Interval 24.7 to 88.6
|
SECONDARY outcome
Timeframe: Predose and at the intervals 1-2, 3-4 and 5-8 hours postdose at Week 2Population: PK population included all participants in the enrolled population and whose DBS was collected.
Outcome measures
| Measure |
Eluxadoline 100 mg With BAM
n=12 Participants
IBS-D participants with evidence of Bile Acid Malabsorption (BAM) treated with eluxadoline 100 mg oral tablets twice daily (BID) with food for 4 weeks.
|
Eluxadoline 100 mg Without BAM
n=12 Participants
IBS-D participants without evidence of BAM treated with eluxadoline 100 mg oral tablets BID with food for 4 weeks.
|
|---|---|---|
|
CL/F: Apparent Total Clearance of the Drug From Plasma After Oral Administration for Eluxadoline
|
20236 liter/hour (L/h)
Standard Deviation 13280
|
21901 liter/hour (L/h)
Standard Deviation 11921
|
SECONDARY outcome
Timeframe: Predose and at the intervals 1-2, 3-4 and 5-8 hours postdose at Week 2Population: PK population included all participants in the enrolled population and whose DBS was collected.
Outcome measures
| Measure |
Eluxadoline 100 mg With BAM
n=12 Participants
IBS-D participants with evidence of Bile Acid Malabsorption (BAM) treated with eluxadoline 100 mg oral tablets twice daily (BID) with food for 4 weeks.
|
Eluxadoline 100 mg Without BAM
n=12 Participants
IBS-D participants without evidence of BAM treated with eluxadoline 100 mg oral tablets BID with food for 4 weeks.
|
|---|---|---|
|
Vc/F: Apparent Volume of Distribution for Eluxadoline
|
29432 L
Standard Deviation 11000
|
39799 L
Standard Deviation 10637
|
Adverse Events
Eluxadoline 100 mg With BAM
Eluxadoline 100 mg Without BAM
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Eluxadoline 100 mg With BAM
n=12 participants at risk
IBS-D participants with evidence of Bile Acid Malabsorption (BAM) treated with eluxadoline 100 mg oral tablets twice daily (BID) with food for 4 weeks.
|
Eluxadoline 100 mg Without BAM
n=12 participants at risk
IBS-D participants without evidence of BAM treated with eluxadoline 100 mg oral tablets BID with food for 4 weeks.
|
|---|---|---|
|
Endocrine disorders
Hypothyroidism
|
8.3%
1/12 • Up to 6 weeks
|
0.00%
0/12 • Up to 6 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
50.0%
6/12 • Up to 6 weeks
|
8.3%
1/12 • Up to 6 weeks
|
|
Gastrointestinal disorders
Flatulence
|
16.7%
2/12 • Up to 6 weeks
|
33.3%
4/12 • Up to 6 weeks
|
|
Gastrointestinal disorders
Abdominal distension
|
16.7%
2/12 • Up to 6 weeks
|
25.0%
3/12 • Up to 6 weeks
|
|
Gastrointestinal disorders
Nausea
|
33.3%
4/12 • Up to 6 weeks
|
8.3%
1/12 • Up to 6 weeks
|
|
Gastrointestinal disorders
Constipation
|
8.3%
1/12 • Up to 6 weeks
|
16.7%
2/12 • Up to 6 weeks
|
|
Gastrointestinal disorders
Abdominal discomfort
|
16.7%
2/12 • Up to 6 weeks
|
0.00%
0/12 • Up to 6 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
16.7%
2/12 • Up to 6 weeks
|
0.00%
0/12 • Up to 6 weeks
|
|
Gastrointestinal disorders
Dry mouth
|
16.7%
2/12 • Up to 6 weeks
|
0.00%
0/12 • Up to 6 weeks
|
|
Gastrointestinal disorders
Dyspepsia
|
16.7%
2/12 • Up to 6 weeks
|
0.00%
0/12 • Up to 6 weeks
|
|
Gastrointestinal disorders
Bowel movement irregularity
|
8.3%
1/12 • Up to 6 weeks
|
0.00%
0/12 • Up to 6 weeks
|
|
Gastrointestinal disorders
Dyschezia
|
8.3%
1/12 • Up to 6 weeks
|
0.00%
0/12 • Up to 6 weeks
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/12 • Up to 6 weeks
|
8.3%
1/12 • Up to 6 weeks
|
|
Gastrointestinal disorders
Vomiting
|
8.3%
1/12 • Up to 6 weeks
|
0.00%
0/12 • Up to 6 weeks
|
|
Metabolism and nutrition disorders
Impaired fasting glucose
|
8.3%
1/12 • Up to 6 weeks
|
0.00%
0/12 • Up to 6 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
8.3%
1/12 • Up to 6 weeks
|
0.00%
0/12 • Up to 6 weeks
|
|
Nervous system disorders
Dizziness
|
16.7%
2/12 • Up to 6 weeks
|
0.00%
0/12 • Up to 6 weeks
|
|
Nervous system disorders
Headache
|
16.7%
2/12 • Up to 6 weeks
|
0.00%
0/12 • Up to 6 weeks
|
|
Nervous system disorders
Dysgeusia
|
8.3%
1/12 • Up to 6 weeks
|
0.00%
0/12 • Up to 6 weeks
|
|
Nervous system disorders
Hypotonia
|
0.00%
0/12 • Up to 6 weeks
|
8.3%
1/12 • Up to 6 weeks
|
|
Psychiatric disorders
Anxiety
|
8.3%
1/12 • Up to 6 weeks
|
0.00%
0/12 • Up to 6 weeks
|
|
Vascular disorders
Hot flush
|
8.3%
1/12 • Up to 6 weeks
|
0.00%
0/12 • Up to 6 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER