Non-Alcoholic Steatohepatitis
Conditions
Brief summary
This study will investigate the safety and tolerability of daily dosing regimens of SHP626 in overweight and obese adults.
Interventions
Sponsors
Study design
Eligibility
Inclusion criteria
* Males that comply with any applicable contraceptive requirements or females of non-childbearing potential * No history of active or chronic disease other than that allowed by study (hypertension, hyperlipidemia and GERD or heartburn) * Has a body mass index of 25-35 kg/m2 with a body weight of greater than 140lbs (assessed at screening)
Exclusion criteria
* No history of alcohol or substance abuse, including use of tobacco * No substantial changes in eating habits or exercise routine.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) | From the start of the study drug administration up to 9 days after the last dose of study drug administration | TEAEs were defined as events that either had a start date on or after the first dose of IMP or has a start date before the date of the first dose of IMP, but increased in severity on or after the date of the first dose of IMP. An AE that occurred more than 9 days after the date of the last dose of double-blind IMP was not counted as a TEAE. |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Standard Chemistry | From the start of the study drug administration up to 9 days after the last dose of study drug administration | TEAEs were defined as events that either had a start date on or after the first dose of IMP or has a start date before the date of the first dose of IMP, but increased in severity on or after the date of the first dose of IMP. An AE that occurred more than 9 days after the date of the last dose of double-blind IMP was not counted as a TEAE. Standard chemistry parameters included evaluation of sodium, potassium, glucose, blood urea nitrogen, creatinine, calcium, chloride, thyrotropin, thyroxine, tri-iodothyronine, phosphorus, protein, bicarbonate or carbon dioxide, albumin, aspartate aminotransferase, alanine aminotransferase, gamma-glutamyltransferase, alkaline phosphatase, total bilirubin, urate, beta-human chorionic gonadotropin and follicle-stimulating hormone levels. Participant with TEAE related to standard chemistry were reported with hepatic enzyme increase. |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Urinalysis Parameters | From the start of the study drug administration up to 9 days after the last dose of study drug administration | TEAEs were defined as events that either had a start date on or after the first dose of IMP or has a start date before the date of the first dose of IMP, but increased in severity on or after the date of the first dose of IMP. An AE that occurred more than 9 days after the date of the last dose of double-blind IMP was not counted as a TEAE. Urinalysis parameters included evaluation of pH, glucose, protein, nitrites, leukocyte esterase, occult blood, ketones, bilirubin and specific gravity levels. |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) Who Discontinued From the Study | From the start of the study drug administration up to 9 days after the last dose of study drug administration | TEAEs were defined as events that either had a start date on or after the first dose of IMP or has a start date before the date of the first dose of IMP, but increased in severity on or after the date of the first dose of IMP. An AE that occurred more than 9 days after the date of the last dose of double-blind IMP was not counted as a TEAE. |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Vital Signs | From the start of the study drug administration up to 9 days after the last dose of study drug administration | TEAEs were defined as events that either had a start date on or after the first dose of IMP or has a start date before the date of the first dose of IMP, but increased in severity on or after the date of the first dose of IMP. An AE that occurred more than 9 days after the date of the last dose of double-blind IMP was not counted as a TEAE. Vital signs parameter included evaluation of orthostatic blood pressure, respiratory rate and body temperature. |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Electrocardiogram (12-lead) | From the start of the study drug administration up to 9 days after the last dose of study drug administration | TEAEs were defined as events that either had a start date on or after the first dose of IMP or has a start date before the date of the first dose of IMP, but increased in severity on or after the date of the first dose of IMP. An AE that occurred more than 9 days after the date of the last dose of double-blind IMP was not counted as a TEAE. Twelve lead electrocardiogram parameters \[(heart rate (HR), PR, RR, QRS and QT intervals and information on T-wave morphology (normal/abnormal) and U-wave morphology (absent/normal or abnormal)\] were assessed. |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Standard Hematology | From the start of the study drug administration up to 9 days after the last dose of study drug administration | TEAEs were defined as events that either had a start date on or after the first dose of investigational medicinal product (IMP) or has a start date before the date of the first dose of IMP, but increased in severity on or after the date of the first dose of IMP. An adverse event (AE) that occurred more than 9 days after the date of the last dose of double-blind IMP was not counted as a TEAE. Hematology parameters included evaluation of hemoglobin, hematocrit, red blood cells, platelets, white blood cell count; total and differential, neutrophils (absolute), eosinophils (absolute), monocytes (absolute), basophils (absolute) and lymphocytes (absolute). |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Fat Soluble Vitamins (Vitamin A, D, & E) | From the start of the study drug administration up to 9 days after the last dose of study drug administration | TEAEs were defined as events that either had a start date on or after the first dose of IMP or has a start date before the date of the first dose of IMP, but increased in severity on or after the date of the first dose of IMP. An AE that occurred more than 9 days after the date of the last dose of double-blind IMP was not counted as a TEAE. Fat soluble vitamin included vitamin A (serum retinol), vitamin D (serum 25-hydroxycholecalciferol) and vitamin E (serum alfa-tocopherol). |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Lipid Panel | From the start of the study drug administration up to 9 days after the last dose of study drug administration | TEAEs were defined as events that either had a start date on or after the first dose of IMP or has a start date before the date of the first dose of IMP, but increased in severity on or after the date of the first dose of IMP. An AE that occurred more than 9 days after the date of the last dose of double-blind IMP was not counted as a TEAE. Lipid panel parameters included evaluation of total cholesterol, triglycerides, high-density lipoprotein (HDL) cholesterol, very low-density lipoprotein (VLDL) cholesterol and low-density lipoprotein (LDL) cholesterol. |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Thyroid Hormone Panel | From the start of the study drug administration up to 9 days after the last dose of study drug administration | TEAEs were defined as events that either had a start date on or after the first dose of IMP or has a start date before the date of the first dose of IMP, but increased in severity on or after the date of the first dose of IMP. An AE that occurred more than 9 days after the date of the last dose of double-blind IMP was not counted as a TEAE. Thyroid hormone panel parameters included evaluation of thyroid hormones (TSH \[thyroid stimulating hormone\]; T3 \[triiodothyronine\] and T4 \[thyroxine\]). |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Coagulation | From the start of the study drug administration up to 9 days after the last dose of study drug administration | TEAEs were defined as events that either had a start date on or after the first dose of IMP or has a start date before the date of the first dose of IMP, but increased in severity on or after the date of the first dose of IMP. An AE that occurred more than 9 days after the date of the last dose of double-blind IMP was not counted as a TEAE. Coagulation included international normalized ratio, activated partial thromboplastin time and prothrombin time. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Day -1 to Day 15 | Serum 7- alpha-hydroxy-4-cholesten-3-one (C4) concentrations were reported. |
| Number of Participants With Stool Hardness Using Bristol Stool Chart | Day -2 to Day 14 | Stool hardness was assessed after each evacuation using the bristol stool chart, a medical aid designed to classify the form of human feces into 7 categories where type 1 is the hardest and type 7 is the softest. |
| Maximum Observed Plasma Concentration (Cmax) of Volixibat | Day 1 to Day 14 | — |
| Area Under the Plasma Concentration-Time Curve (AUC) of Volixibat (SHP626) | Day 1 to Day 14 | — |
| Average Total Fecal Bile Acid (FBA) Concentration | Day -2 up to Day 14 | Stool samples for the determination of total FBA were collected in 48-hour windows from 48 hours before dosing on Day 1 through Day 14. The average of daily total FBA excretion is calculated before (Day -1 and Day -2) as the first pre dose of IMP and after (Day 1-12) as the first post-dose of IMP. The FBA is calculated as Total FBA (micromoles) = FBA (micromol per liter) \* weight (grams) divided by 10\^3. Participants with fecal bile acid concentration and their average pre-first dose and average post-first dose were reported. |
Countries
United States
Participant flow
Recruitment details
Study was conducted at one study centre in North America, from 19 January 2015 to 19 June 2015.
Pre-assignment details
Overall, 84 participants were randomised and completed the study.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Participants received placebo matched to volixibat tablet orally for 12 days | 21 |
| Volixibat 5 mg BID Participants received volixibat (SHP626) 5 milligram (mg) capsule orally twice a day (BID) for 12 days. | 9 |
| Volixibat 10 mg QD Participants received volixibat (SHP626) 10 mg capsule orally once a day (QD) for 12 days. | 9 |
| Volixibat 20 mg QD Participants received volixibat (SHP626) 20 mg capsule orally QD for 12 days. | 9 |
| Volixibat 2-5-10-20 mg QD Participants received volixibat (SHP626) 2 mg capsule orally QD on Days 1-3, 5 mg capsule orally QD on Days 4-6, 10 mg capsule QD orally on Days 7-9, and 20 mg capsule QD orally on Days 10-12. | 9 |
| Volixibat 30 mg QD Participants received volixibat (SHP626) 30 mg capsule orally QD for 12 days. | 9 |
| Volixibat 40 mg QD Participants received volixibat (SHP626) 40 mg capsule orally QD for 12 days. | 9 |
| Volixibat 80-40-20 mg QD Participants received volixibat (SHP626) 80 mg capsule orally QD on Day 1, 40 mg capsule orally QD on Day 2, and 20 mg capsule orally QD on Days 3-12. | 9 |
| Total | 84 |
Baseline characteristics
| Characteristic | Placebo | Volixibat 5 mg BID | Volixibat 10 mg QD | Volixibat 20 mg QD | Volixibat 2-5-10-20 mg QD | Volixibat 30 mg QD | Volixibat 40 mg QD | Volixibat 80-40-20 mg QD | Total |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous Age | 41.5 years STANDARD_DEVIATION 9.47 | 37.1 years STANDARD_DEVIATION 15.4 | 46.2 years STANDARD_DEVIATION 7.61 | 33.3 years STANDARD_DEVIATION 9.82 | 46.2 years STANDARD_DEVIATION 7.82 | 44.6 years STANDARD_DEVIATION 10.7 | 36.6 years STANDARD_DEVIATION 8.92 | 33.2 years STANDARD_DEVIATION 11.34 | 40.1 years STANDARD_DEVIATION 10.93 |
| Sex: Female, Male Female | 3 Participants | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 6 Participants |
| Sex: Female, Male Male | 18 Participants | 9 Participants | 7 Participants | 9 Participants | 9 Participants | 8 Participants | 9 Participants | 9 Participants | 78 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 13 / 21 | 9 / 9 | 9 / 9 | 9 / 9 | 9 / 9 | 9 / 9 | 9 / 9 | 9 / 9 |
| serious Total, serious adverse events | 0 / 21 | 0 / 9 | 0 / 9 | 0 / 9 | 0 / 9 | 0 / 9 | 0 / 9 | 0 / 9 |
Outcome results
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs)
TEAEs were defined as events that either had a start date on or after the first dose of IMP or has a start date before the date of the first dose of IMP, but increased in severity on or after the date of the first dose of IMP. An AE that occurred more than 9 days after the date of the last dose of double-blind IMP was not counted as a TEAE.
Time frame: From the start of the study drug administration up to 9 days after the last dose of study drug administration
Population: Safety analysis set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) | Participants with TEAEs | 14 participants |
| Placebo | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) | Participants with STEAEs | 0 participants |
| Volixibat 5 mg BID | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) | Participants with TEAEs | 9 participants |
| Volixibat 5 mg BID | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) | Participants with STEAEs | 0 participants |
| Volixibat 10 mg QD | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) | Participants with TEAEs | 9 participants |
| Volixibat 10 mg QD | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) | Participants with STEAEs | 0 participants |
| Volixibat 20 mg QD | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) | Participants with TEAEs | 9 participants |
| Volixibat 20 mg QD | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) | Participants with STEAEs | 0 participants |
| Volixibat 2-5-10-20 mg QD | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) | Participants with TEAEs | 9 participants |
| Volixibat 2-5-10-20 mg QD | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) | Participants with STEAEs | 0 participants |
| Volixibat 30 mg QD | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) | Participants with TEAEs | 9 participants |
| Volixibat 30 mg QD | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) | Participants with STEAEs | 0 participants |
| Volixibat 40 mg QD | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) | Participants with STEAEs | 0 participants |
| Volixibat 40 mg QD | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) | Participants with TEAEs | 9 participants |
| Volixibat 80-40-20 mg QD | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) | Participants with TEAEs | 9 participants |
| Volixibat 80-40-20 mg QD | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) | Participants with STEAEs | 0 participants |
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Coagulation
TEAEs were defined as events that either had a start date on or after the first dose of IMP or has a start date before the date of the first dose of IMP, but increased in severity on or after the date of the first dose of IMP. An AE that occurred more than 9 days after the date of the last dose of double-blind IMP was not counted as a TEAE. Coagulation included international normalized ratio, activated partial thromboplastin time and prothrombin time.
Time frame: From the start of the study drug administration up to 9 days after the last dose of study drug administration
Population: Safety analysis set.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Coagulation | 0 participants |
| Volixibat 5 mg BID | Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Coagulation | 0 participants |
| Volixibat 10 mg QD | Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Coagulation | 0 participants |
| Volixibat 20 mg QD | Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Coagulation | 0 participants |
| Volixibat 2-5-10-20 mg QD | Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Coagulation | 0 participants |
| Volixibat 30 mg QD | Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Coagulation | 0 participants |
| Volixibat 40 mg QD | Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Coagulation | 0 participants |
| Volixibat 80-40-20 mg QD | Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Coagulation | 0 participants |
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Electrocardiogram (12-lead)
TEAEs were defined as events that either had a start date on or after the first dose of IMP or has a start date before the date of the first dose of IMP, but increased in severity on or after the date of the first dose of IMP. An AE that occurred more than 9 days after the date of the last dose of double-blind IMP was not counted as a TEAE. Twelve lead electrocardiogram parameters \[(heart rate (HR), PR, RR, QRS and QT intervals and information on T-wave morphology (normal/abnormal) and U-wave morphology (absent/normal or abnormal)\] were assessed.
Time frame: From the start of the study drug administration up to 9 days after the last dose of study drug administration
Population: Safety analysis set.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Electrocardiogram (12-lead) | 0 participants |
| Volixibat 5 mg BID | Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Electrocardiogram (12-lead) | 0 participants |
| Volixibat 10 mg QD | Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Electrocardiogram (12-lead) | 0 participants |
| Volixibat 20 mg QD | Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Electrocardiogram (12-lead) | 0 participants |
| Volixibat 2-5-10-20 mg QD | Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Electrocardiogram (12-lead) | 0 participants |
| Volixibat 30 mg QD | Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Electrocardiogram (12-lead) | 0 participants |
| Volixibat 40 mg QD | Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Electrocardiogram (12-lead) | 0 participants |
| Volixibat 80-40-20 mg QD | Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Electrocardiogram (12-lead) | 0 participants |
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Fat Soluble Vitamins (Vitamin A, D, & E)
TEAEs were defined as events that either had a start date on or after the first dose of IMP or has a start date before the date of the first dose of IMP, but increased in severity on or after the date of the first dose of IMP. An AE that occurred more than 9 days after the date of the last dose of double-blind IMP was not counted as a TEAE. Fat soluble vitamin included vitamin A (serum retinol), vitamin D (serum 25-hydroxycholecalciferol) and vitamin E (serum alfa-tocopherol).
Time frame: From the start of the study drug administration up to 9 days after the last dose of study drug administration
Population: Safety analysis set.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Fat Soluble Vitamins (Vitamin A, D, & E) | 0 participants |
| Volixibat 5 mg BID | Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Fat Soluble Vitamins (Vitamin A, D, & E) | 0 participants |
| Volixibat 10 mg QD | Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Fat Soluble Vitamins (Vitamin A, D, & E) | 0 participants |
| Volixibat 20 mg QD | Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Fat Soluble Vitamins (Vitamin A, D, & E) | 0 participants |
| Volixibat 2-5-10-20 mg QD | Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Fat Soluble Vitamins (Vitamin A, D, & E) | 0 participants |
| Volixibat 30 mg QD | Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Fat Soluble Vitamins (Vitamin A, D, & E) | 0 participants |
| Volixibat 40 mg QD | Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Fat Soluble Vitamins (Vitamin A, D, & E) | 0 participants |
| Volixibat 80-40-20 mg QD | Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Fat Soluble Vitamins (Vitamin A, D, & E) | 0 participants |
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Lipid Panel
TEAEs were defined as events that either had a start date on or after the first dose of IMP or has a start date before the date of the first dose of IMP, but increased in severity on or after the date of the first dose of IMP. An AE that occurred more than 9 days after the date of the last dose of double-blind IMP was not counted as a TEAE. Lipid panel parameters included evaluation of total cholesterol, triglycerides, high-density lipoprotein (HDL) cholesterol, very low-density lipoprotein (VLDL) cholesterol and low-density lipoprotein (LDL) cholesterol.
Time frame: From the start of the study drug administration up to 9 days after the last dose of study drug administration
Population: Safety analysis set.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Lipid Panel | 0 participants |
| Volixibat 5 mg BID | Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Lipid Panel | 0 participants |
| Volixibat 10 mg QD | Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Lipid Panel | 0 participants |
| Volixibat 20 mg QD | Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Lipid Panel | 0 participants |
| Volixibat 2-5-10-20 mg QD | Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Lipid Panel | 0 participants |
| Volixibat 30 mg QD | Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Lipid Panel | 0 participants |
| Volixibat 40 mg QD | Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Lipid Panel | 0 participants |
| Volixibat 80-40-20 mg QD | Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Lipid Panel | 0 participants |
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Standard Chemistry
TEAEs were defined as events that either had a start date on or after the first dose of IMP or has a start date before the date of the first dose of IMP, but increased in severity on or after the date of the first dose of IMP. An AE that occurred more than 9 days after the date of the last dose of double-blind IMP was not counted as a TEAE. Standard chemistry parameters included evaluation of sodium, potassium, glucose, blood urea nitrogen, creatinine, calcium, chloride, thyrotropin, thyroxine, tri-iodothyronine, phosphorus, protein, bicarbonate or carbon dioxide, albumin, aspartate aminotransferase, alanine aminotransferase, gamma-glutamyltransferase, alkaline phosphatase, total bilirubin, urate, beta-human chorionic gonadotropin and follicle-stimulating hormone levels. Participant with TEAE related to standard chemistry were reported with hepatic enzyme increase.
Time frame: From the start of the study drug administration up to 9 days after the last dose of study drug administration
Population: Safety analysis set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Standard Chemistry | 0 participants |
| Volixibat 5 mg BID | Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Standard Chemistry | 0 participants |
| Volixibat 10 mg QD | Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Standard Chemistry | 0 participants |
| Volixibat 20 mg QD | Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Standard Chemistry | 1 participants |
| Volixibat 2-5-10-20 mg QD | Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Standard Chemistry | 0 participants |
| Volixibat 30 mg QD | Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Standard Chemistry | 0 participants |
| Volixibat 40 mg QD | Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Standard Chemistry | 0 participants |
| Volixibat 80-40-20 mg QD | Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Standard Chemistry | 0 participants |
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Standard Hematology
TEAEs were defined as events that either had a start date on or after the first dose of investigational medicinal product (IMP) or has a start date before the date of the first dose of IMP, but increased in severity on or after the date of the first dose of IMP. An adverse event (AE) that occurred more than 9 days after the date of the last dose of double-blind IMP was not counted as a TEAE. Hematology parameters included evaluation of hemoglobin, hematocrit, red blood cells, platelets, white blood cell count; total and differential, neutrophils (absolute), eosinophils (absolute), monocytes (absolute), basophils (absolute) and lymphocytes (absolute).
Time frame: From the start of the study drug administration up to 9 days after the last dose of study drug administration
Population: Safety analysis set included all participants for whom a randomization number was assigned and who had taken \>= 1 dose of IMP.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Standard Hematology | 0 participants |
| Volixibat 5 mg BID | Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Standard Hematology | 0 participants |
| Volixibat 10 mg QD | Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Standard Hematology | 0 participants |
| Volixibat 20 mg QD | Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Standard Hematology | 0 participants |
| Volixibat 2-5-10-20 mg QD | Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Standard Hematology | 0 participants |
| Volixibat 30 mg QD | Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Standard Hematology | 0 participants |
| Volixibat 40 mg QD | Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Standard Hematology | 0 participants |
| Volixibat 80-40-20 mg QD | Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Standard Hematology | 0 participants |
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Thyroid Hormone Panel
TEAEs were defined as events that either had a start date on or after the first dose of IMP or has a start date before the date of the first dose of IMP, but increased in severity on or after the date of the first dose of IMP. An AE that occurred more than 9 days after the date of the last dose of double-blind IMP was not counted as a TEAE. Thyroid hormone panel parameters included evaluation of thyroid hormones (TSH \[thyroid stimulating hormone\]; T3 \[triiodothyronine\] and T4 \[thyroxine\]).
Time frame: From the start of the study drug administration up to 9 days after the last dose of study drug administration
Population: Safety analysis set.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Thyroid Hormone Panel | 0 participants |
| Volixibat 5 mg BID | Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Thyroid Hormone Panel | 0 participants |
| Volixibat 10 mg QD | Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Thyroid Hormone Panel | 0 participants |
| Volixibat 20 mg QD | Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Thyroid Hormone Panel | 0 participants |
| Volixibat 2-5-10-20 mg QD | Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Thyroid Hormone Panel | 0 participants |
| Volixibat 30 mg QD | Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Thyroid Hormone Panel | 0 participants |
| Volixibat 40 mg QD | Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Thyroid Hormone Panel | 0 participants |
| Volixibat 80-40-20 mg QD | Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Thyroid Hormone Panel | 0 participants |
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Urinalysis Parameters
TEAEs were defined as events that either had a start date on or after the first dose of IMP or has a start date before the date of the first dose of IMP, but increased in severity on or after the date of the first dose of IMP. An AE that occurred more than 9 days after the date of the last dose of double-blind IMP was not counted as a TEAE. Urinalysis parameters included evaluation of pH, glucose, protein, nitrites, leukocyte esterase, occult blood, ketones, bilirubin and specific gravity levels.
Time frame: From the start of the study drug administration up to 9 days after the last dose of study drug administration
Population: Safety analysis set.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Urinalysis Parameters | 0 participants |
| Volixibat 5 mg BID | Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Urinalysis Parameters | 0 participants |
| Volixibat 10 mg QD | Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Urinalysis Parameters | 0 participants |
| Volixibat 20 mg QD | Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Urinalysis Parameters | 0 participants |
| Volixibat 2-5-10-20 mg QD | Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Urinalysis Parameters | 0 participants |
| Volixibat 30 mg QD | Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Urinalysis Parameters | 0 participants |
| Volixibat 40 mg QD | Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Urinalysis Parameters | 0 participants |
| Volixibat 80-40-20 mg QD | Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Urinalysis Parameters | 0 participants |
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Vital Signs
TEAEs were defined as events that either had a start date on or after the first dose of IMP or has a start date before the date of the first dose of IMP, but increased in severity on or after the date of the first dose of IMP. An AE that occurred more than 9 days after the date of the last dose of double-blind IMP was not counted as a TEAE. Vital signs parameter included evaluation of orthostatic blood pressure, respiratory rate and body temperature.
Time frame: From the start of the study drug administration up to 9 days after the last dose of study drug administration
Population: Safety analysis set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Vital Signs | Tachycardia | 0 participants |
| Placebo | Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Vital Signs | Pyrexia | 0 participants |
| Volixibat 5 mg BID | Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Vital Signs | Tachycardia | 1 participants |
| Volixibat 5 mg BID | Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Vital Signs | Pyrexia | 2 participants |
| Volixibat 10 mg QD | Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Vital Signs | Tachycardia | 0 participants |
| Volixibat 10 mg QD | Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Vital Signs | Pyrexia | 0 participants |
| Volixibat 20 mg QD | Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Vital Signs | Tachycardia | 0 participants |
| Volixibat 20 mg QD | Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Vital Signs | Pyrexia | 0 participants |
| Volixibat 2-5-10-20 mg QD | Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Vital Signs | Tachycardia | 0 participants |
| Volixibat 2-5-10-20 mg QD | Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Vital Signs | Pyrexia | 0 participants |
| Volixibat 30 mg QD | Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Vital Signs | Tachycardia | 0 participants |
| Volixibat 30 mg QD | Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Vital Signs | Pyrexia | 0 participants |
| Volixibat 40 mg QD | Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Vital Signs | Pyrexia | 0 participants |
| Volixibat 40 mg QD | Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Vital Signs | Tachycardia | 0 participants |
| Volixibat 80-40-20 mg QD | Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Vital Signs | Tachycardia | 0 participants |
| Volixibat 80-40-20 mg QD | Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Vital Signs | Pyrexia | 0 participants |
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Who Discontinued From the Study
TEAEs were defined as events that either had a start date on or after the first dose of IMP or has a start date before the date of the first dose of IMP, but increased in severity on or after the date of the first dose of IMP. An AE that occurred more than 9 days after the date of the last dose of double-blind IMP was not counted as a TEAE.
Time frame: From the start of the study drug administration up to 9 days after the last dose of study drug administration
Population: Safety analysis set.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Participants With Treatment-emergent Adverse Events (TEAEs) Who Discontinued From the Study | 0 participants |
| Volixibat 5 mg BID | Number of Participants With Treatment-emergent Adverse Events (TEAEs) Who Discontinued From the Study | 0 participants |
| Volixibat 10 mg QD | Number of Participants With Treatment-emergent Adverse Events (TEAEs) Who Discontinued From the Study | 0 participants |
| Volixibat 20 mg QD | Number of Participants With Treatment-emergent Adverse Events (TEAEs) Who Discontinued From the Study | 0 participants |
| Volixibat 2-5-10-20 mg QD | Number of Participants With Treatment-emergent Adverse Events (TEAEs) Who Discontinued From the Study | 0 participants |
| Volixibat 30 mg QD | Number of Participants With Treatment-emergent Adverse Events (TEAEs) Who Discontinued From the Study | 0 participants |
| Volixibat 40 mg QD | Number of Participants With Treatment-emergent Adverse Events (TEAEs) Who Discontinued From the Study | 0 participants |
| Volixibat 80-40-20 mg QD | Number of Participants With Treatment-emergent Adverse Events (TEAEs) Who Discontinued From the Study | 0 participants |
Area Under the Plasma Concentration-Time Curve (AUC) of Volixibat (SHP626)
Time frame: Day 1 to Day 14
Population: Pharmacokinetic set. Due to minimal absorption of volixibat no participant had sufficient and interpretable primary pharmacokinetic data.
Average Total Fecal Bile Acid (FBA) Concentration
Stool samples for the determination of total FBA were collected in 48-hour windows from 48 hours before dosing on Day 1 through Day 14. The average of daily total FBA excretion is calculated before (Day -1 and Day -2) as the first pre dose of IMP and after (Day 1-12) as the first post-dose of IMP. The FBA is calculated as Total FBA (micromoles) = FBA (micromol per liter) \* weight (grams) divided by 10\^3. Participants with fecal bile acid concentration and their average pre-first dose and average post-first dose were reported.
Time frame: Day -2 up to Day 14
Population: Pharmacodynamic set consisted of all participant in the safety analysis set for whom the primary pharmacodynamic data were considered sufficient and interpretable.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Average Total Fecal Bile Acid (FBA) Concentration | Average Pre First Dose | 183.84 nanomoles*gram per liter | Standard Deviation 176.229 |
| Placebo | Average Total Fecal Bile Acid (FBA) Concentration | Average Post First Dose | 224.75 nanomoles*gram per liter | Standard Deviation 195.403 |
| Volixibat 5 mg BID | Average Total Fecal Bile Acid (FBA) Concentration | Average Pre First Dose | 166.95 nanomoles*gram per liter | Standard Deviation 84.057 |
| Volixibat 5 mg BID | Average Total Fecal Bile Acid (FBA) Concentration | Average Post First Dose | 941.32 nanomoles*gram per liter | Standard Deviation 338.783 |
| Volixibat 10 mg QD | Average Total Fecal Bile Acid (FBA) Concentration | Average Pre First Dose | 172.49 nanomoles*gram per liter | Standard Deviation 180.992 |
| Volixibat 10 mg QD | Average Total Fecal Bile Acid (FBA) Concentration | Average Post First Dose | 668.64 nanomoles*gram per liter | Standard Deviation 365.183 |
| Volixibat 20 mg QD | Average Total Fecal Bile Acid (FBA) Concentration | Average Pre First Dose | 238.22 nanomoles*gram per liter | Standard Deviation 211.406 |
| Volixibat 20 mg QD | Average Total Fecal Bile Acid (FBA) Concentration | Average Post First Dose | 1051.86 nanomoles*gram per liter | Standard Deviation 554.781 |
| Volixibat 2-5-10-20 mg QD | Average Total Fecal Bile Acid (FBA) Concentration | Average Pre First Dose | 364.78 nanomoles*gram per liter | Standard Deviation 304.905 |
| Volixibat 2-5-10-20 mg QD | Average Total Fecal Bile Acid (FBA) Concentration | Average Post First Dose | 1055.60 nanomoles*gram per liter | Standard Deviation 394.246 |
| Volixibat 30 mg QD | Average Total Fecal Bile Acid (FBA) Concentration | Average Pre First Dose | 408.49 nanomoles*gram per liter | Standard Deviation 475.553 |
| Volixibat 30 mg QD | Average Total Fecal Bile Acid (FBA) Concentration | Average Post First Dose | 987.01 nanomoles*gram per liter | Standard Deviation 321.184 |
| Volixibat 40 mg QD | Average Total Fecal Bile Acid (FBA) Concentration | Average Post First Dose | 1172.08 nanomoles*gram per liter | Standard Deviation 591.774 |
| Volixibat 40 mg QD | Average Total Fecal Bile Acid (FBA) Concentration | Average Pre First Dose | 335.89 nanomoles*gram per liter | Standard Deviation 277.883 |
| Volixibat 80-40-20 mg QD | Average Total Fecal Bile Acid (FBA) Concentration | Average Pre First Dose | 116.73 nanomoles*gram per liter | Standard Deviation 91.962 |
| Volixibat 80-40-20 mg QD | Average Total Fecal Bile Acid (FBA) Concentration | Average Post First Dose | 665.82 nanomoles*gram per liter | Standard Deviation 539.15 |
Maximum Observed Plasma Concentration (Cmax) of Volixibat
Time frame: Day 1 to Day 14
Population: Pharmacokinetic set consisted of all participants in the safety analysis set for whom the primary pharmacokinetic data were considered sufficient and interpretable. Due to minimal absorption of volixibat no participant had sufficient and interpretable primary pharmacokinetic data.
Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration
Serum 7- alpha-hydroxy-4-cholesten-3-one (C4) concentrations were reported.
Time frame: Day -1 to Day 15
Population: Pharmacodynamic set.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Day 1, 5 Hours Post-Dose | 27.300 nanogram per milliliter | Standard Deviation 21.4321 |
| Placebo | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Day 12, 5 Hours Post-Dose | 32.567 nanogram per milliliter | Standard Deviation 24.7723 |
| Placebo | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Day -1, Pre-Dose | 15.702 nanogram per milliliter | Standard Deviation 19.1363 |
| Placebo | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Day 15, Pre-Dose | 21.848 nanogram per milliliter | Standard Deviation 24.0679 |
| Placebo | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Day 6, 13 Hours Post-Dose | 15.847 nanogram per milliliter | Standard Deviation 13.7638 |
| Placebo | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Day 6, 5 Hours Post-Dose | 33.972 nanogram per milliliter | Standard Deviation 20.7411 |
| Placebo | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Day 12, 13 Hours Post-Dose | 16.497 nanogram per milliliter | Standard Deviation 12.915 |
| Placebo | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Day -1, 13 Hours Post-Dose | 11.830 nanogram per milliliter | Standard Deviation 10.3028 |
| Placebo | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Day 13, 13 Hours Post-Dose | 22.728 nanogram per milliliter | Standard Deviation 24.6379 |
| Placebo | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Day 13, Pre-Dose | 21.822 nanogram per milliliter | Standard Deviation 32.8831 |
| Placebo | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Day 13, 5 Hours Post-Dose | 29.110 nanogram per milliliter | Standard Deviation 22.6451 |
| Placebo | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Day 6, Pre-Dose | 34.048 nanogram per milliliter | Standard Deviation 57.5519 |
| Placebo | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Day 15, 13 Hours Post-Dose | 19.140 nanogram per milliliter | Standard Deviation 18.9237 |
| Placebo | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Day 1, Pre-Dose | 17.464 nanogram per milliliter | Standard Deviation 29.6114 |
| Placebo | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Day 15, 5 Hours Post-Dose | 30.099 nanogram per milliliter | Standard Deviation 19.2391 |
| Placebo | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Baseline | 17.464 nanogram per milliliter | Standard Deviation 29.6114 |
| Placebo | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Day -1, 5 Hours Post-Dose | 31.952 nanogram per milliliter | Standard Deviation 29.6023 |
| Placebo | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Day 12, Pre-Dose | 23.299 nanogram per milliliter | Standard Deviation 26.1217 |
| Placebo | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Day 1, 13 Hours Post-Dose | 22.930 nanogram per milliliter | Standard Deviation 29.6148 |
| Volixibat 5 mg BID | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Day 1, 13 Hours Post-Dose | 32.991 nanogram per milliliter | Standard Deviation 23.3494 |
| Volixibat 5 mg BID | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Day 13, 13 Hours Post-Dose | 67.660 nanogram per milliliter | Standard Deviation 46.6124 |
| Volixibat 5 mg BID | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Day 1, Pre-Dose | 10.644 nanogram per milliliter | Standard Deviation 6.2617 |
| Volixibat 5 mg BID | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Day -1, Pre-Dose | 10.956 nanogram per milliliter | Standard Deviation 3.7149 |
| Volixibat 5 mg BID | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Day 1, 5 Hours Post-Dose | 29.041 nanogram per milliliter | Standard Deviation 18.4231 |
| Volixibat 5 mg BID | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Day 6, 13 Hours Post-Dose | 71.200 nanogram per milliliter | Standard Deviation 30.2892 |
| Volixibat 5 mg BID | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Day 12, 13 Hours Post-Dose | 77.636 nanogram per milliliter | Standard Deviation 40.5962 |
| Volixibat 5 mg BID | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Day 15, 5 Hours Post-Dose | 34.663 nanogram per milliliter | Standard Deviation 14.0156 |
| Volixibat 5 mg BID | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Day -1, 5 Hours Post-Dose | 17.418 nanogram per milliliter | Standard Deviation 9.3636 |
| Volixibat 5 mg BID | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Day 6, 5 Hours Post-Dose | 129.625 nanogram per milliliter | Standard Deviation 71.4311 |
| Volixibat 5 mg BID | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Day 15, 13 Hours Post-Dose | 21.068 nanogram per milliliter | Standard Deviation 10.4419 |
| Volixibat 5 mg BID | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Day 13, 5 Hours Post-Dose | 107.325 nanogram per milliliter | Standard Deviation 59.7595 |
| Volixibat 5 mg BID | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Day -1, 13 Hours Post-Dose | 6.224 nanogram per milliliter | Standard Deviation 3.9307 |
| Volixibat 5 mg BID | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Day 12, 5 Hours Post-Dose | 120.738 nanogram per milliliter | Standard Deviation 61.5278 |
| Volixibat 5 mg BID | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Day 6, Pre-Dose | 100.788 nanogram per milliliter | Standard Deviation 48.0025 |
| Volixibat 5 mg BID | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Day 13, Pre-Dose | 130.750 nanogram per milliliter | Standard Deviation 85.2496 |
| Volixibat 5 mg BID | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Day 12, Pre-Dose | 97.538 nanogram per milliliter | Standard Deviation 68.033 |
| Volixibat 5 mg BID | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Day 15, Pre-Dose | 14.454 nanogram per milliliter | Standard Deviation 11.0078 |
| Volixibat 5 mg BID | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Baseline | 10.644 nanogram per milliliter | Standard Deviation 6.2617 |
| Volixibat 10 mg QD | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Day 13, 5 Hours Post-Dose | 94.022 nanogram per milliliter | Standard Deviation 73.9921 |
| Volixibat 10 mg QD | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Day 12, 5 Hours Post-Dose | 144.767 nanogram per milliliter | Standard Deviation 130.3808 |
| Volixibat 10 mg QD | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Day 12, 13 Hours Post-Dose | 80.189 nanogram per milliliter | Standard Deviation 77.9001 |
| Volixibat 10 mg QD | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Day -1, 5 Hours Post-Dose | 26.272 nanogram per milliliter | Standard Deviation 24.6615 |
| Volixibat 10 mg QD | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Day -1, 13 Hours Post-Dose | 10.463 nanogram per milliliter | Standard Deviation 7.9914 |
| Volixibat 10 mg QD | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Day 15, 13 Hours Post-Dose | 31.759 nanogram per milliliter | Standard Deviation 28.8913 |
| Volixibat 10 mg QD | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Day 15, Pre-Dose | 25.908 nanogram per milliliter | Standard Deviation 18.3102 |
| Volixibat 10 mg QD | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Baseline | 10.441 nanogram per milliliter | Standard Deviation 7.8955 |
| Volixibat 10 mg QD | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Day 1, Pre-Dose | 10.441 nanogram per milliliter | Standard Deviation 7.8955 |
| Volixibat 10 mg QD | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Day 13, 13 Hours Post-Dose | 53.333 nanogram per milliliter | Standard Deviation 40.0821 |
| Volixibat 10 mg QD | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Day 1, 5 Hours Post-Dose | 54.602 nanogram per milliliter | Standard Deviation 47.7655 |
| Volixibat 10 mg QD | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Day 1, 13 Hours Post-Dose | 57.611 nanogram per milliliter | Standard Deviation 28.4635 |
| Volixibat 10 mg QD | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Day 6, Pre-Dose | 103.789 nanogram per milliliter | Standard Deviation 66.6396 |
| Volixibat 10 mg QD | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Day 15, 5 Hours Post-Dose | 51.009 nanogram per milliliter | Standard Deviation 39.8047 |
| Volixibat 10 mg QD | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Day -1, Pre-Dose | 13.806 nanogram per milliliter | Standard Deviation 10.0637 |
| Volixibat 10 mg QD | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Day 6, 5 Hours Post-Dose | 145.111 nanogram per milliliter | Standard Deviation 84.6147 |
| Volixibat 10 mg QD | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Day 6, 13 Hours Post-Dose | 84.611 nanogram per milliliter | Standard Deviation 71.3102 |
| Volixibat 10 mg QD | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Day 13, Pre-Dose | 84.544 nanogram per milliliter | Standard Deviation 55.4006 |
| Volixibat 10 mg QD | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Day 12, Pre-Dose | 101.522 nanogram per milliliter | Standard Deviation 95.1932 |
| Volixibat 20 mg QD | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Day 15, 13 Hours Post-Dose | 23.667 nanogram per milliliter | Standard Deviation 10.0772 |
| Volixibat 20 mg QD | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Baseline | 15.446 nanogram per milliliter | Standard Deviation 13.4289 |
| Volixibat 20 mg QD | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Day -1, Pre-Dose | 11.129 nanogram per milliliter | Standard Deviation 6.7566 |
| Volixibat 20 mg QD | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Day 1, 13 Hours Post-Dose | 60.922 nanogram per milliliter | Standard Deviation 20.1868 |
| Volixibat 20 mg QD | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Day 15, 5 Hours Post-Dose | 30.868 nanogram per milliliter | Standard Deviation 19.5278 |
| Volixibat 20 mg QD | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Day 13, 5 Hours Post-Dose | 78.100 nanogram per milliliter | Standard Deviation 34.5601 |
| Volixibat 20 mg QD | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Day -1, 13 Hours Post-Dose | 15.812 nanogram per milliliter | Standard Deviation 7.6084 |
| Volixibat 20 mg QD | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Day 13, Pre-Dose | 85.822 nanogram per milliliter | Standard Deviation 42.7988 |
| Volixibat 20 mg QD | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Day 6, Pre-Dose | 114.289 nanogram per milliliter | Standard Deviation 81.4964 |
| Volixibat 20 mg QD | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Day 12, Pre-Dose | 118.900 nanogram per milliliter | Standard Deviation 78.4954 |
| Volixibat 20 mg QD | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Day 15, Pre-Dose | 19.906 nanogram per milliliter | Standard Deviation 11.2784 |
| Volixibat 20 mg QD | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Day 12, 5 Hours Post-Dose | 156.689 nanogram per milliliter | Standard Deviation 67.9233 |
| Volixibat 20 mg QD | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Day 6, 5 Hours Post-Dose | 143.756 nanogram per milliliter | Standard Deviation 80.3355 |
| Volixibat 20 mg QD | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Day -1, 5 Hours Post-Dose | 35.649 nanogram per milliliter | Standard Deviation 22.7807 |
| Volixibat 20 mg QD | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Day 12, 13 Hours Post-Dose | 90.400 nanogram per milliliter | Standard Deviation 55.9921 |
| Volixibat 20 mg QD | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Day 13, 13 Hours Post-Dose | 65.833 nanogram per milliliter | Standard Deviation 34.3484 |
| Volixibat 20 mg QD | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Day 6, 13 Hours Post-Dose | 88.722 nanogram per milliliter | Standard Deviation 68.5693 |
| Volixibat 20 mg QD | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Day 1, Pre-Dose | 15.446 nanogram per milliliter | Standard Deviation 13.4289 |
| Volixibat 20 mg QD | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Day 1, 5 Hours Post-Dose | 60.478 nanogram per milliliter | Standard Deviation 22.8216 |
| Volixibat 2-5-10-20 mg QD | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Day 1, 5 Hours Post-Dose | 65.289 nanogram per milliliter | Standard Deviation 22.8088 |
| Volixibat 2-5-10-20 mg QD | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Baseline | 26.871 nanogram per milliliter | Standard Deviation 17.6706 |
| Volixibat 2-5-10-20 mg QD | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Day 1, Pre-Dose | 26.871 nanogram per milliliter | Standard Deviation 17.6706 |
| Volixibat 2-5-10-20 mg QD | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Day 6, 5 Hours Post-Dose | 185.278 nanogram per milliliter | Standard Deviation 88.4269 |
| Volixibat 2-5-10-20 mg QD | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Day 15, 5 Hours Post-Dose | 63.067 nanogram per milliliter | Standard Deviation 34.0796 |
| Volixibat 2-5-10-20 mg QD | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Day 1, 13 Hours Post-Dose | 65.478 nanogram per milliliter | Standard Deviation 27.8476 |
| Volixibat 2-5-10-20 mg QD | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Day -1, Pre-Dose | 19.549 nanogram per milliliter | Standard Deviation 12.2775 |
| Volixibat 2-5-10-20 mg QD | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Day 13, 5 Hours Post-Dose | 161.556 nanogram per milliliter | Standard Deviation 95.9363 |
| Volixibat 2-5-10-20 mg QD | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Day 13, Pre-Dose | 184.222 nanogram per milliliter | Standard Deviation 66.6179 |
| Volixibat 2-5-10-20 mg QD | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Day -1, 13 Hours Post-Dose | 17.013 nanogram per milliliter | Standard Deviation 9.7056 |
| Volixibat 2-5-10-20 mg QD | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Day 6, 13 Hours Post-Dose | 98.122 nanogram per milliliter | Standard Deviation 43.582 |
| Volixibat 2-5-10-20 mg QD | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Day 12, 13 Hours Post-Dose | 152.989 nanogram per milliliter | Standard Deviation 81.6364 |
| Volixibat 2-5-10-20 mg QD | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Day 12, Pre-Dose | 198.311 nanogram per milliliter | Standard Deviation 87.5824 |
| Volixibat 2-5-10-20 mg QD | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Day 6, Pre-Dose | 157.718 nanogram per milliliter | Standard Deviation 69.9298 |
| Volixibat 2-5-10-20 mg QD | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Day 15, 13 Hours Post-Dose | 49.867 nanogram per milliliter | Standard Deviation 21.1864 |
| Volixibat 2-5-10-20 mg QD | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Day 12, 5 Hours Post-Dose | 232.189 nanogram per milliliter | Standard Deviation 106.785 |
| Volixibat 2-5-10-20 mg QD | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Day 13, 13 Hours Post-Dose | 78.911 nanogram per milliliter | Standard Deviation 50.2001 |
| Volixibat 2-5-10-20 mg QD | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Day 15, Pre-Dose | 38.434 nanogram per milliliter | Standard Deviation 21.0173 |
| Volixibat 2-5-10-20 mg QD | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Day -1, 5 Hours Post-Dose | 34.262 nanogram per milliliter | Standard Deviation 19.5308 |
| Volixibat 30 mg QD | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Day 15, 5 Hours Post-Dose | 55.257 nanogram per milliliter | Standard Deviation 47.2884 |
| Volixibat 30 mg QD | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Day 15, 13 Hours Post-Dose | 29.282 nanogram per milliliter | Standard Deviation 23.4813 |
| Volixibat 30 mg QD | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Day -1, Pre-Dose | 24.726 nanogram per milliliter | Standard Deviation 37.6474 |
| Volixibat 30 mg QD | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Day -1, 5 Hours Post-Dose | 42.490 nanogram per milliliter | Standard Deviation 37.9101 |
| Volixibat 30 mg QD | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Day -1, 13 Hours Post-Dose | 16.459 nanogram per milliliter | Standard Deviation 15.9875 |
| Volixibat 30 mg QD | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Baseline | 25.269 nanogram per milliliter | Standard Deviation 34.4194 |
| Volixibat 30 mg QD | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Day 1, Pre-Dose | 25.269 nanogram per milliliter | Standard Deviation 34.4194 |
| Volixibat 30 mg QD | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Day 1, 5 Hours Post-Dose | 63.769 nanogram per milliliter | Standard Deviation 54.1516 |
| Volixibat 30 mg QD | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Day 1, 13 Hours Post-Dose | 88.300 nanogram per milliliter | Standard Deviation 64.8546 |
| Volixibat 30 mg QD | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Day 6, Pre-Dose | 134.378 nanogram per milliliter | Standard Deviation 90.2305 |
| Volixibat 30 mg QD | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Day 6, 5 Hours Post-Dose | 190.378 nanogram per milliliter | Standard Deviation 96.9316 |
| Volixibat 30 mg QD | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Day 6, 13 Hours Post-Dose | 110.167 nanogram per milliliter | Standard Deviation 46.8967 |
| Volixibat 30 mg QD | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Day 12, Pre-Dose | 169.778 nanogram per milliliter | Standard Deviation 101.2574 |
| Volixibat 30 mg QD | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Day 12, 5 Hours Post-Dose | 196.933 nanogram per milliliter | Standard Deviation 118.2849 |
| Volixibat 30 mg QD | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Day 12, 13 Hours Post-Dose | 114.500 nanogram per milliliter | Standard Deviation 40.2073 |
| Volixibat 30 mg QD | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Day 13, Pre-Dose | 126.322 nanogram per milliliter | Standard Deviation 65.9867 |
| Volixibat 30 mg QD | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Day 13, 5 Hours Post-Dose | 110.756 nanogram per milliliter | Standard Deviation 49.6502 |
| Volixibat 30 mg QD | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Day 13, 13 Hours Post-Dose | 66.633 nanogram per milliliter | Standard Deviation 23.7029 |
| Volixibat 30 mg QD | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Day 15, Pre-Dose | 38.870 nanogram per milliliter | Standard Deviation 38.5249 |
| Volixibat 40 mg QD | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Day 1, Pre-Dose | 45.714 nanogram per milliliter | Standard Deviation 49.4616 |
| Volixibat 40 mg QD | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Day 6, Pre-Dose | 190.025 nanogram per milliliter | Standard Deviation 114.5808 |
| Volixibat 40 mg QD | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Day 13, Pre-Dose | 128.738 nanogram per milliliter | Standard Deviation 83.4282 |
| Volixibat 40 mg QD | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Day 13, 13 Hours Post-Dose | 66.550 nanogram per milliliter | Standard Deviation 30.6498 |
| Volixibat 40 mg QD | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Day 1, 13 Hours Post-Dose | 104.150 nanogram per milliliter | Standard Deviation 65.606 |
| Volixibat 40 mg QD | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Baseline | 45.714 nanogram per milliliter | Standard Deviation 49.4616 |
| Volixibat 40 mg QD | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Day 15, 13 Hours Post-Dose | 32.750 nanogram per milliliter | Standard Deviation 22.6428 |
| Volixibat 40 mg QD | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Day -1, 13 Hours Post-Dose | 26.676 nanogram per milliliter | Standard Deviation 26.9306 |
| Volixibat 40 mg QD | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Day 13, 5 Hours Post-Dose | 89.363 nanogram per milliliter | Standard Deviation 39.2784 |
| Volixibat 40 mg QD | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Day -1, 5 Hours Post-Dose | 58.411 nanogram per milliliter | Standard Deviation 61.0322 |
| Volixibat 40 mg QD | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Day 15, 5 Hours Post-Dose | 36.960 nanogram per milliliter | Standard Deviation 18.2242 |
| Volixibat 40 mg QD | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Day 15, Pre-Dose | 37.300 nanogram per milliliter | Standard Deviation 26.1975 |
| Volixibat 40 mg QD | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Day 12, Pre-Dose | 192.225 nanogram per milliliter | Standard Deviation 128.8916 |
| Volixibat 40 mg QD | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Day 6, 5 Hours Post-Dose | 202.788 nanogram per milliliter | Standard Deviation 122.4445 |
| Volixibat 40 mg QD | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Day 1, 5 Hours Post-Dose | 88.713 nanogram per milliliter | Standard Deviation 53.8752 |
| Volixibat 40 mg QD | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Day 12, 5 Hours Post-Dose | 210.088 nanogram per milliliter | Standard Deviation 117.8523 |
| Volixibat 40 mg QD | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Day -1, Pre-Dose | 47.138 nanogram per milliliter | Standard Deviation 42.798 |
| Volixibat 40 mg QD | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Day 12, 13 Hours Post-Dose | 107.875 nanogram per milliliter | Standard Deviation 52.3505 |
| Volixibat 40 mg QD | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Day 6, 13 Hours Post-Dose | 129.100 nanogram per milliliter | Standard Deviation 74.277 |
| Volixibat 80-40-20 mg QD | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Day 12, 13 Hours Post-Dose | 66.444 nanogram per milliliter | Standard Deviation 36.9048 |
| Volixibat 80-40-20 mg QD | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Day 6, 13 Hours Post-Dose | 76.811 nanogram per milliliter | Standard Deviation 40.678 |
| Volixibat 80-40-20 mg QD | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Day 6, 5 Hours Post-Dose | 100.089 nanogram per milliliter | Standard Deviation 45.3246 |
| Volixibat 80-40-20 mg QD | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Day 15, 13 Hours Post-Dose | 19.173 nanogram per milliliter | Standard Deviation 8.3821 |
| Volixibat 80-40-20 mg QD | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Day 13, Pre-Dose | 72.867 nanogram per milliliter | Standard Deviation 49.7977 |
| Volixibat 80-40-20 mg QD | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Day 6, Pre-Dose | 111.346 nanogram per milliliter | Standard Deviation 91.6773 |
| Volixibat 80-40-20 mg QD | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Day 1, 13 Hours Post-Dose | 66.311 nanogram per milliliter | Standard Deviation 21.3091 |
| Volixibat 80-40-20 mg QD | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Day 13, 5 Hours Post-Dose | 57.567 nanogram per milliliter | Standard Deviation 28.0922 |
| Volixibat 80-40-20 mg QD | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Day 1, 5 Hours Post-Dose | 35.520 nanogram per milliliter | Standard Deviation 18.2429 |
| Volixibat 80-40-20 mg QD | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Day 1, Pre-Dose | 19.453 nanogram per milliliter | Standard Deviation 16.9595 |
| Volixibat 80-40-20 mg QD | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Baseline | 19.453 nanogram per milliliter | Standard Deviation 16.9595 |
| Volixibat 80-40-20 mg QD | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Day 15, 5 Hours Post-Dose | 26.322 nanogram per milliliter | Standard Deviation 12.8678 |
| Volixibat 80-40-20 mg QD | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Day 13, 13 Hours Post-Dose | 50.333 nanogram per milliliter | Standard Deviation 23.8917 |
| Volixibat 80-40-20 mg QD | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Day -1, 13 Hours Post-Dose | 13.977 nanogram per milliliter | Standard Deviation 8.4524 |
| Volixibat 80-40-20 mg QD | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Day -1, 5 Hours Post-Dose | 27.311 nanogram per milliliter | Standard Deviation 14.7722 |
| Volixibat 80-40-20 mg QD | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Day 15, Pre-Dose | 17.563 nanogram per milliliter | Standard Deviation 12.4113 |
| Volixibat 80-40-20 mg QD | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Day -1, Pre-Dose | 22.632 nanogram per milliliter | Standard Deviation 18.9895 |
| Volixibat 80-40-20 mg QD | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Day 12, 5 Hours Post-Dose | 104.167 nanogram per milliliter | Standard Deviation 68.2195 |
| Volixibat 80-40-20 mg QD | Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration | Day 12, Pre-Dose | 107.200 nanogram per milliliter | Standard Deviation 77.8666 |
Number of Participants With Stool Hardness Using Bristol Stool Chart
Stool hardness was assessed after each evacuation using the bristol stool chart, a medical aid designed to classify the form of human feces into 7 categories where type 1 is the hardest and type 7 is the softest.
Time frame: Day -2 to Day 14
Population: Pharmacodynamic set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 6: Type 1 | 3 participants |
| Placebo | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day -1: Type 6 | 3 participants |
| Placebo | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 7: Type 6 | 4 participants |
| Placebo | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 2: Type 6 | 2 participants |
| Placebo | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 9: Type 5 | 1 participants |
| Placebo | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 12: Type 2 | 6 participants |
| Placebo | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 9: Type 6 | 4 participants |
| Placebo | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 5: Type 5 | 2 participants |
| Placebo | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 12: Type 1 | 2 participants |
| Placebo | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day -1: Type 7 | 1 participants |
| Placebo | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 14: Type 1 | 1 participants |
| Placebo | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day -2: Type 2 | 2 participants |
| Placebo | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 7: Type 7 | 0 participants |
| Placebo | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 2: Type 5 | 1 participants |
| Placebo | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 13: Type 7 | 1 participants |
| Placebo | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 11: Type 7 | 0 participants |
| Placebo | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 9: Type 7 | 0 participants |
| Placebo | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 1: Type 1 | 1 participants |
| Placebo | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 6: Type 7 | 0 participants |
| Placebo | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 14: Type 3 | 1 participants |
| Placebo | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 5: Type 7 | 0 participants |
| Placebo | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 4: Type 1 | 6 participants |
| Placebo | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 11: Type 6 | 2 participants |
| Placebo | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 2: Type 4 | 5 participants |
| Placebo | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 5: Type 6 | 4 participants |
| Placebo | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 1: Type 2 | 4 participants |
| Placebo | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 8: Type 1 | 3 participants |
| Placebo | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 10: Type 1 | 3 participants |
| Placebo | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 11: Type 5 | 2 participants |
| Placebo | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 2: Type 3 | 4 participants |
| Placebo | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 5: Type 2 | 5 participants |
| Placebo | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 1: Type 3 | 3 participants |
| Placebo | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 13: Type 6 | 4 participants |
| Placebo | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 10: Type 2 | 6 participants |
| Placebo | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day -2: Type 5 | 3 participants |
| Placebo | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 11: Type 4 | 6 participants |
| Placebo | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 10: Type 3 | 2 participants |
| Placebo | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 6: Type 6 | 4 participants |
| Placebo | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 11: Type 3 | 2 participants |
| Placebo | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 1: Type 4 | 1 participants |
| Placebo | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day -2: Type 3 | 5 participants |
| Placebo | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 2: Type 2 | 5 participants |
| Placebo | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day -2: Type 1 | 4 participants |
| Placebo | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 10: Type 4 | 4 participants |
| Placebo | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 4: Type 5 | 3 participants |
| Placebo | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 11: Type 2 | 2 participants |
| Placebo | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 14: Type 4 | 3 participants |
| Placebo | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 1: Type 5 | 1 participants |
| Placebo | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 2: Type 1 | 1 participants |
| Placebo | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 3: Type 7 | 1 participants |
| Placebo | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 4: Type 6 | 2 participants |
| Placebo | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 11: Type 1 | 5 participants |
| Placebo | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 10: Type 5 | 2 participants |
| Placebo | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 13: Type 5 | 0 participants |
| Placebo | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 1: Type 6 | 2 participants |
| Placebo | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 8: Type 2 | 6 participants |
| Placebo | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 1: Type 7 | 1 participants |
| Placebo | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 10: Type 6 | 1 participants |
| Placebo | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 10: Type 7 | 0 participants |
| Placebo | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day -2: Type 6 | 0 participants |
| Placebo | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 6: Type 4 | 2 participants |
| Placebo | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 3: Type 6 | 1 participants |
| Placebo | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 14: Type 6 | 1 participants |
| Placebo | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 7: Type 3 | 1 participants |
| Placebo | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 13: Type 4 | 6 participants |
| Placebo | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 8: Type 3 | 1 participants |
| Placebo | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 5: Type 1 | 0 participants |
| Placebo | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day -2: Type 7 | 0 participants |
| Placebo | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 6: Type 3 | 3 participants |
| Placebo | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 8: Type 4 | 3 participants |
| Placebo | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 14: Type 2 | 5 participants |
| Placebo | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 13: Type 3 | 0 participants |
| Placebo | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 3: Type 5 | 3 participants |
| Placebo | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 5: Type 3 | 3 participants |
| Placebo | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 13: Type 2 | 5 participants |
| Placebo | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day -1: Type 1 | 2 participants |
| Placebo | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 4: Type 7 | 0 participants |
| Placebo | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 8: Type 5 | 2 participants |
| Placebo | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 3: Type 4 | 4 participants |
| Placebo | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 8: Type 6 | 0 participants |
| Placebo | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 4: Type 4 | 2 participants |
| Placebo | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 13: Type 1 | 3 participants |
| Placebo | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 3: Type 3 | 0 participants |
| Placebo | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day -1: Type 2 | 0 participants |
| Placebo | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 7: Type 4 | 4 participants |
| Placebo | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 4: Type 3 | 3 participants |
| Placebo | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 12: Type 7 | 0 participants |
| Placebo | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 8: Type 7 | 1 participants |
| Placebo | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 7: Type 2 | 4 participants |
| Placebo | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day -1: Type 3 | 8 participants |
| Placebo | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 6: Type 2 | 6 participants |
| Placebo | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 3: Type 2 | 6 participants |
| Placebo | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 14: Type 5 | 3 participants |
| Placebo | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 12: Type 6 | 2 participants |
| Placebo | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 9: Type 1 | 1 participants |
| Placebo | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 5: Type 4 | 1 participants |
| Placebo | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 12: Type 5 | 0 participants |
| Placebo | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day -1: Type 4 | 3 participants |
| Placebo | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day -2: Type 4 | 5 participants |
| Placebo | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 9: Type 2 | 5 participants |
| Placebo | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 14: Type 7 | 0 participants |
| Placebo | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 3: Type 1 | 1 participants |
| Placebo | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 7: Type 5 | 2 participants |
| Placebo | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 12: Type 4 | 2 participants |
| Placebo | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 9: Type 3 | 1 participants |
| Placebo | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day -1: Type 5 | 1 participants |
| Placebo | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 7: Type 1 | 4 participants |
| Placebo | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 2: Type 7 | 0 participants |
| Placebo | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 4: Type 2 | 3 participants |
| Placebo | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 6: Type 5 | 0 participants |
| Placebo | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 12: Type 3 | 2 participants |
| Placebo | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 9: Type 4 | 4 participants |
| Volixibat 5 mg BID | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 6: Type 7 | 2 participants |
| Volixibat 5 mg BID | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 4: Type 7 | 1 participants |
| Volixibat 5 mg BID | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 13: Type 7 | 0 participants |
| Volixibat 5 mg BID | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 6: Type 6 | 4 participants |
| Volixibat 5 mg BID | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 5: Type 1 | 0 participants |
| Volixibat 5 mg BID | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 6: Type 5 | 0 participants |
| Volixibat 5 mg BID | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 6: Type 4 | 0 participants |
| Volixibat 5 mg BID | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 5: Type 2 | 0 participants |
| Volixibat 5 mg BID | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day -2: Type 4 | 1 participants |
| Volixibat 5 mg BID | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 6: Type 3 | 1 participants |
| Volixibat 5 mg BID | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 5: Type 3 | 1 participants |
| Volixibat 5 mg BID | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 6: Type 2 | 1 participants |
| Volixibat 5 mg BID | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 5: Type 4 | 0 participants |
| Volixibat 5 mg BID | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 5: Type 6 | 5 participants |
| Volixibat 5 mg BID | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 6: Type 1 | 0 participants |
| Volixibat 5 mg BID | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 5: Type 5 | 0 participants |
| Volixibat 5 mg BID | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 5: Type 7 | 1 participants |
| Volixibat 5 mg BID | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 13: Type 6 | 2 participants |
| Volixibat 5 mg BID | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day -2: Type 5 | 0 participants |
| Volixibat 5 mg BID | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 14: Type 6 | 0 participants |
| Volixibat 5 mg BID | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 13: Type 5 | 1 participants |
| Volixibat 5 mg BID | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day -2: Type 6 | 0 participants |
| Volixibat 5 mg BID | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 13: Type 4 | 0 participants |
| Volixibat 5 mg BID | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 13: Type 3 | 1 participants |
| Volixibat 5 mg BID | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day -2: Type 7 | 0 participants |
| Volixibat 5 mg BID | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 13: Type 2 | 0 participants |
| Volixibat 5 mg BID | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day -1: Type 1 | 1 participants |
| Volixibat 5 mg BID | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 13: Type 1 | 0 participants |
| Volixibat 5 mg BID | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 14: Type 5 | 1 participants |
| Volixibat 5 mg BID | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 12: Type 7 | 1 participants |
| Volixibat 5 mg BID | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 12: Type 6 | 4 participants |
| Volixibat 5 mg BID | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day -1: Type 3 | 2 participants |
| Volixibat 5 mg BID | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 12: Type 5 | 2 participants |
| Volixibat 5 mg BID | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day -1: Type 4 | 1 participants |
| Volixibat 5 mg BID | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 12: Type 4 | 0 participants |
| Volixibat 5 mg BID | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day -1: Type 5 | 0 participants |
| Volixibat 5 mg BID | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day -1: Type 2 | 1 participants |
| Volixibat 5 mg BID | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 12: Type 3 | 0 participants |
| Volixibat 5 mg BID | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 12: Type 2 | 0 participants |
| Volixibat 5 mg BID | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day -1: Type 6 | 1 participants |
| Volixibat 5 mg BID | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 12: Type 1 | 0 participants |
| Volixibat 5 mg BID | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day -1: Type 7 | 0 participants |
| Volixibat 5 mg BID | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 3: Type 7 | 2 participants |
| Volixibat 5 mg BID | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 11: Type 7 | 4 participants |
| Volixibat 5 mg BID | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 1: Type 1 | 0 participants |
| Volixibat 5 mg BID | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 14: Type 4 | 3 participants |
| Volixibat 5 mg BID | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 11: Type 6 | 3 participants |
| Volixibat 5 mg BID | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 11: Type 5 | 1 participants |
| Volixibat 5 mg BID | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 1: Type 2 | 1 participants |
| Volixibat 5 mg BID | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 11: Type 4 | 0 participants |
| Volixibat 5 mg BID | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 1: Type 3 | 0 participants |
| Volixibat 5 mg BID | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 1: Type 5 | 4 participants |
| Volixibat 5 mg BID | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 11: Type 3 | 0 participants |
| Volixibat 5 mg BID | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 1: Type 4 | 0 participants |
| Volixibat 5 mg BID | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 11: Type 2 | 0 participants |
| Volixibat 5 mg BID | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day -2: Type 1 | 0 participants |
| Volixibat 5 mg BID | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 11: Type 1 | 0 participants |
| Volixibat 5 mg BID | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 10: Type 7 | 1 participants |
| Volixibat 5 mg BID | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 1: Type 6 | 2 participants |
| Volixibat 5 mg BID | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 10: Type 6 | 5 participants |
| Volixibat 5 mg BID | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 1: Type 7 | 1 participants |
| Volixibat 5 mg BID | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 14: Type 7 | 0 participants |
| Volixibat 5 mg BID | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 10: Type 5 | 0 participants |
| Volixibat 5 mg BID | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 2: Type 1 | 0 participants |
| Volixibat 5 mg BID | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 10: Type 4 | 0 participants |
| Volixibat 5 mg BID | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 10: Type 3 | 1 participants |
| Volixibat 5 mg BID | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 3: Type 3 | 0 participants |
| Volixibat 5 mg BID | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 2: Type 2 | 0 participants |
| Volixibat 5 mg BID | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 10: Type 2 | 0 participants |
| Volixibat 5 mg BID | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 2: Type 3 | 0 participants |
| Volixibat 5 mg BID | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 14: Type 3 | 1 participants |
| Volixibat 5 mg BID | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 10: Type 1 | 0 participants |
| Volixibat 5 mg BID | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 2: Type 4 | 1 participants |
| Volixibat 5 mg BID | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 9: Type 7 | 2 participants |
| Volixibat 5 mg BID | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 9: Type 6 | 3 participants |
| Volixibat 5 mg BID | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 2: Type 5 | 1 participants |
| Volixibat 5 mg BID | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 9: Type 5 | 1 participants |
| Volixibat 5 mg BID | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 2: Type 6 | 4 participants |
| Volixibat 5 mg BID | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day -2: Type 2 | 1 participants |
| Volixibat 5 mg BID | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 9: Type 4 | 0 participants |
| Volixibat 5 mg BID | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 2: Type 7 | 1 participants |
| Volixibat 5 mg BID | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 9: Type 3 | 0 participants |
| Volixibat 5 mg BID | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 9: Type 2 | 0 participants |
| Volixibat 5 mg BID | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 3: Type 1 | 0 participants |
| Volixibat 5 mg BID | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 9: Type 1 | 0 participants |
| Volixibat 5 mg BID | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 3: Type 2 | 0 participants |
| Volixibat 5 mg BID | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 8: Type 7 | 0 participants |
| Volixibat 5 mg BID | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 14: Type 2 | 1 participants |
| Volixibat 5 mg BID | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 8: Type 6 | 4 participants |
| Volixibat 5 mg BID | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 8: Type 5 | 2 participants |
| Volixibat 5 mg BID | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 3: Type 4 | 1 participants |
| Volixibat 5 mg BID | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 8: Type 4 | 0 participants |
| Volixibat 5 mg BID | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 3: Type 5 | 0 participants |
| Volixibat 5 mg BID | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 8: Type 3 | 0 participants |
| Volixibat 5 mg BID | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 3: Type 6 | 4 participants |
| Volixibat 5 mg BID | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 8: Type 2 | 0 participants |
| Volixibat 5 mg BID | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 8: Type 1 | 0 participants |
| Volixibat 5 mg BID | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 7: Type 7 | 0 participants |
| Volixibat 5 mg BID | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 4: Type 1 | 0 participants |
| Volixibat 5 mg BID | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day -2: Type 3 | 3 participants |
| Volixibat 5 mg BID | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 7: Type 6 | 6 participants |
| Volixibat 5 mg BID | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 4: Type 2 | 0 participants |
| Volixibat 5 mg BID | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 7: Type 5 | 0 participants |
| Volixibat 5 mg BID | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 4: Type 3 | 0 participants |
| Volixibat 5 mg BID | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 7: Type 4 | 0 participants |
| Volixibat 5 mg BID | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 4: Type 4 | 0 participants |
| Volixibat 5 mg BID | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 14: Type 1 | 0 participants |
| Volixibat 5 mg BID | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 7: Type 3 | 0 participants |
| Volixibat 5 mg BID | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 7: Type 2 | 0 participants |
| Volixibat 5 mg BID | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 4: Type 5 | 1 participants |
| Volixibat 5 mg BID | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 7: Type 1 | 0 participants |
| Volixibat 5 mg BID | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 4: Type 6 | 3 participants |
| Volixibat 10 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 4: Type 2 | 0 participants |
| Volixibat 10 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 2: Type 6 | 6 participants |
| Volixibat 10 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day -2: Type 3 | 1 participants |
| Volixibat 10 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 9: Type 4 | 0 participants |
| Volixibat 10 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 7: Type 5 | 2 participants |
| Volixibat 10 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 12: Type 2 | 0 participants |
| Volixibat 10 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 9: Type 3 | 0 participants |
| Volixibat 10 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day -1: Type 5 | 1 participants |
| Volixibat 10 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 5: Type 1 | 0 participants |
| Volixibat 10 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 2: Type 7 | 0 participants |
| Volixibat 10 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day -2: Type 2 | 1 participants |
| Volixibat 10 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 5: Type 4 | 0 participants |
| Volixibat 10 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 12: Type 3 | 0 participants |
| Volixibat 10 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 3: Type 6 | 5 participants |
| Volixibat 10 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 9: Type 2 | 0 participants |
| Volixibat 10 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 6: Type 2 | 0 participants |
| Volixibat 10 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 12: Type 4 | 0 participants |
| Volixibat 10 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 7: Type 1 | 0 participants |
| Volixibat 10 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 3: Type 1 | 0 participants |
| Volixibat 10 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 14: Type 4 | 2 participants |
| Volixibat 10 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day -1: Type 4 | 4 participants |
| Volixibat 10 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 9: Type 1 | 0 participants |
| Volixibat 10 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 4: Type 3 | 1 participants |
| Volixibat 10 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 12: Type 5 | 0 participants |
| Volixibat 10 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day -1: Type 3 | 1 participants |
| Volixibat 10 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 14: Type 6 | 1 participants |
| Volixibat 10 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 3: Type 2 | 1 participants |
| Volixibat 10 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 14: Type 2 | 0 participants |
| Volixibat 10 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 8: Type 7 | 0 participants |
| Volixibat 10 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 7: Type 4 | 0 participants |
| Volixibat 10 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 12: Type 6 | 7 participants |
| Volixibat 10 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 8: Type 6 | 5 participants |
| Volixibat 10 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 12: Type 7 | 0 participants |
| Volixibat 10 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 3: Type 3 | 0 participants |
| Volixibat 10 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 6: Type 7 | 2 participants |
| Volixibat 10 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day -2: Type 4 | 5 participants |
| Volixibat 10 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 13: Type 1 | 0 participants |
| Volixibat 10 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 8: Type 5 | 3 participants |
| Volixibat 10 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 7: Type 3 | 0 participants |
| Volixibat 10 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 14: Type 5 | 1 participants |
| Volixibat 10 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 5: Type 3 | 1 participants |
| Volixibat 10 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 3: Type 4 | 1 participants |
| Volixibat 10 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day -1: Type 1 | 0 participants |
| Volixibat 10 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 8: Type 4 | 0 participants |
| Volixibat 10 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 6: Type 5 | 0 participants |
| Volixibat 10 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 13: Type 2 | 0 participants |
| Volixibat 10 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 4: Type 4 | 2 participants |
| Volixibat 10 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 3: Type 5 | 0 participants |
| Volixibat 10 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 14: Type 7 | 0 participants |
| Volixibat 10 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day -2: Type 7 | 0 participants |
| Volixibat 10 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 8: Type 3 | 0 participants |
| Volixibat 10 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 4: Type 7 | 0 participants |
| Volixibat 10 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 13: Type 3 | 0 participants |
| Volixibat 10 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day -2: Type 6 | 0 participants |
| Volixibat 10 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 4: Type 6 | 2 participants |
| Volixibat 10 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 14: Type 1 | 0 participants |
| Volixibat 10 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 8: Type 2 | 0 participants |
| Volixibat 10 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 6: Type 3 | 0 participants |
| Volixibat 10 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 13: Type 4 | 1 participants |
| Volixibat 10 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 10: Type 6 | 4 participants |
| Volixibat 10 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 8: Type 1 | 0 participants |
| Volixibat 10 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day -2: Type 1 | 1 participants |
| Volixibat 10 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 1: Type 6 | 5 participants |
| Volixibat 10 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 13: Type 5 | 1 participants |
| Volixibat 10 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 1: Type 7 | 2 participants |
| Volixibat 10 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 3: Type 7 | 1 participants |
| Volixibat 10 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 10: Type 5 | 1 participants |
| Volixibat 10 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day -2: Type 5 | 1 participants |
| Volixibat 10 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 10: Type 7 | 2 participants |
| Volixibat 10 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 10: Type 4 | 1 participants |
| Volixibat 10 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 1: Type 5 | 1 participants |
| Volixibat 10 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 7: Type 2 | 0 participants |
| Volixibat 10 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 2: Type 1 | 0 participants |
| Volixibat 10 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 11: Type 1 | 0 participants |
| Volixibat 10 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 13: Type 6 | 3 participants |
| Volixibat 10 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 11: Type 2 | 0 participants |
| Volixibat 10 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 10: Type 3 | 0 participants |
| Volixibat 10 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 4: Type 1 | 0 participants |
| Volixibat 10 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 1: Type 4 | 0 participants |
| Volixibat 10 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 7: Type 7 | 0 participants |
| Volixibat 10 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 13: Type 7 | 0 participants |
| Volixibat 10 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 11: Type 3 | 0 participants |
| Volixibat 10 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 2: Type 2 | 0 participants |
| Volixibat 10 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 14: Type 3 | 2 participants |
| Volixibat 10 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 10: Type 2 | 0 participants |
| Volixibat 10 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 5: Type 6 | 6 participants |
| Volixibat 10 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 1: Type 3 | 0 participants |
| Volixibat 10 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 11: Type 4 | 0 participants |
| Volixibat 10 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 5: Type 2 | 0 participants |
| Volixibat 10 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 2: Type 3 | 0 participants |
| Volixibat 10 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 6: Type 6 | 4 participants |
| Volixibat 10 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 10: Type 1 | 0 participants |
| Volixibat 10 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 5: Type 5 | 0 participants |
| Volixibat 10 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 1: Type 2 | 0 participants |
| Volixibat 10 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 9: Type 7 | 0 participants |
| Volixibat 10 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 11: Type 5 | 0 participants |
| Volixibat 10 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 7: Type 6 | 5 participants |
| Volixibat 10 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 2: Type 4 | 1 participants |
| Volixibat 10 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 1: Type 1 | 0 participants |
| Volixibat 10 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 4: Type 5 | 3 participants |
| Volixibat 10 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 11: Type 6 | 9 participants |
| Volixibat 10 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 9: Type 6 | 8 participants |
| Volixibat 10 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 5: Type 7 | 2 participants |
| Volixibat 10 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 11: Type 7 | 0 participants |
| Volixibat 10 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 6: Type 1 | 0 participants |
| Volixibat 10 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 2: Type 5 | 2 participants |
| Volixibat 10 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day -1: Type 7 | 0 participants |
| Volixibat 10 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 12: Type 1 | 0 participants |
| Volixibat 10 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 9: Type 5 | 0 participants |
| Volixibat 10 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 6: Type 4 | 2 participants |
| Volixibat 10 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day -1: Type 2 | 1 participants |
| Volixibat 10 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day -1: Type 6 | 1 participants |
| Volixibat 20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 3: Type 4 | 0 participants |
| Volixibat 20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 9: Type 2 | 0 participants |
| Volixibat 20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 1: Type 2 | 0 participants |
| Volixibat 20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day -2: Type 1 | 0 participants |
| Volixibat 20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day -2: Type 2 | 1 participants |
| Volixibat 20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day -2: Type 3 | 1 participants |
| Volixibat 20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day -2: Type 4 | 1 participants |
| Volixibat 20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day -2: Type 5 | 3 participants |
| Volixibat 20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day -2: Type 6 | 0 participants |
| Volixibat 20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day -2: Type 7 | 1 participants |
| Volixibat 20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day -1: Type 1 | 1 participants |
| Volixibat 20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day -1: Type 2 | 2 participants |
| Volixibat 20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day -1: Type 3 | 2 participants |
| Volixibat 20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day -1: Type 4 | 1 participants |
| Volixibat 20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day -1: Type 5 | 0 participants |
| Volixibat 20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day -1: Type 6 | 1 participants |
| Volixibat 20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day -1: Type 7 | 1 participants |
| Volixibat 20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 1: Type 1 | 0 participants |
| Volixibat 20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 1: Type 3 | 0 participants |
| Volixibat 20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 1: Type 4 | 0 participants |
| Volixibat 20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 1: Type 5 | 2 participants |
| Volixibat 20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 1: Type 6 | 3 participants |
| Volixibat 20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 1: Type 7 | 4 participants |
| Volixibat 20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 2: Type 1 | 0 participants |
| Volixibat 20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 2: Type 2 | 0 participants |
| Volixibat 20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 2: Type 3 | 1 participants |
| Volixibat 20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 2: Type 4 | 0 participants |
| Volixibat 20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 2: Type 5 | 1 participants |
| Volixibat 20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 2: Type 6 | 4 participants |
| Volixibat 20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 2: Type 7 | 2 participants |
| Volixibat 20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 3: Type 1 | 0 participants |
| Volixibat 20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 3: Type 2 | 0 participants |
| Volixibat 20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 3: Type 3 | 0 participants |
| Volixibat 20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 3: Type 5 | 0 participants |
| Volixibat 20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 3: Type 6 | 8 participants |
| Volixibat 20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 3: Type 7 | 0 participants |
| Volixibat 20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 4: Type 1 | 0 participants |
| Volixibat 20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 4: Type 2 | 0 participants |
| Volixibat 20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 4: Type 3 | 0 participants |
| Volixibat 20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 4: Type 4 | 0 participants |
| Volixibat 20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 4: Type 5 | 1 participants |
| Volixibat 20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 4: Type 6 | 5 participants |
| Volixibat 20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 4: Type 7 | 2 participants |
| Volixibat 20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 5: Type 1 | 0 participants |
| Volixibat 20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 5: Type 2 | 0 participants |
| Volixibat 20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 5: Type 3 | 0 participants |
| Volixibat 20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 5: Type 4 | 0 participants |
| Volixibat 20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 5: Type 5 | 0 participants |
| Volixibat 20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 5: Type 6 | 5 participants |
| Volixibat 20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 5: Type 7 | 2 participants |
| Volixibat 20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 6: Type 1 | 0 participants |
| Volixibat 20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 6: Type 2 | 0 participants |
| Volixibat 20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 6: Type 3 | 0 participants |
| Volixibat 20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 6: Type 4 | 0 participants |
| Volixibat 20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 6: Type 5 | 0 participants |
| Volixibat 20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 6: Type 6 | 7 participants |
| Volixibat 20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 6: Type 7 | 1 participants |
| Volixibat 20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 7: Type 1 | 0 participants |
| Volixibat 20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 7: Type 2 | 0 participants |
| Volixibat 20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 7: Type 3 | 0 participants |
| Volixibat 20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 7: Type 4 | 0 participants |
| Volixibat 20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 7: Type 5 | 1 participants |
| Volixibat 20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 7: Type 6 | 5 participants |
| Volixibat 20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 7: Type 7 | 1 participants |
| Volixibat 20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 8: Type 1 | 0 participants |
| Volixibat 20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 8: Type 2 | 0 participants |
| Volixibat 20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 8: Type 3 | 1 participants |
| Volixibat 20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 8: Type 4 | 0 participants |
| Volixibat 20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 8: Type 5 | 0 participants |
| Volixibat 20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 8: Type 6 | 4 participants |
| Volixibat 20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 8: Type 7 | 3 participants |
| Volixibat 20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 9: Type 1 | 0 participants |
| Volixibat 20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 9: Type 3 | 0 participants |
| Volixibat 20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 9: Type 4 | 0 participants |
| Volixibat 20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 9: Type 5 | 0 participants |
| Volixibat 20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 9: Type 6 | 6 participants |
| Volixibat 20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 9: Type 7 | 3 participants |
| Volixibat 20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 10: Type 1 | 0 participants |
| Volixibat 20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 10: Type 2 | 0 participants |
| Volixibat 20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 10: Type 3 | 0 participants |
| Volixibat 20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 10: Type 4 | 0 participants |
| Volixibat 20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 10: Type 5 | 0 participants |
| Volixibat 20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 10: Type 6 | 4 participants |
| Volixibat 20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 10: Type 7 | 4 participants |
| Volixibat 20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 11: Type 1 | 0 participants |
| Volixibat 20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 11: Type 2 | 0 participants |
| Volixibat 20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 11: Type 3 | 0 participants |
| Volixibat 20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 11: Type 4 | 0 participants |
| Volixibat 20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 11: Type 5 | 0 participants |
| Volixibat 20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 11: Type 6 | 9 participants |
| Volixibat 20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 11: Type 7 | 0 participants |
| Volixibat 20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 12: Type 1 | 0 participants |
| Volixibat 20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 12: Type 2 | 0 participants |
| Volixibat 20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 12: Type 3 | 0 participants |
| Volixibat 20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 12: Type 4 | 0 participants |
| Volixibat 20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 12: Type 5 | 1 participants |
| Volixibat 20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 12: Type 6 | 3 participants |
| Volixibat 20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 12: Type 7 | 4 participants |
| Volixibat 20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 13: Type 1 | 0 participants |
| Volixibat 20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 13: Type 2 | 0 participants |
| Volixibat 20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 13: Type 3 | 0 participants |
| Volixibat 20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 13: Type 4 | 2 participants |
| Volixibat 20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 13: Type 5 | 1 participants |
| Volixibat 20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 13: Type 6 | 1 participants |
| Volixibat 20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 13: Type 7 | 0 participants |
| Volixibat 20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 14: Type 1 | 1 participants |
| Volixibat 20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 14: Type 2 | 0 participants |
| Volixibat 20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 14: Type 3 | 0 participants |
| Volixibat 20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 14: Type 4 | 4 participants |
| Volixibat 20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 14: Type 5 | 1 participants |
| Volixibat 20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 14: Type 6 | 1 participants |
| Volixibat 20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 14: Type 7 | 1 participants |
| Volixibat 2-5-10-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 14: Type 2 | 2 participants |
| Volixibat 2-5-10-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 8: Type 7 | 2 participants |
| Volixibat 2-5-10-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 11: Type 2 | 0 participants |
| Volixibat 2-5-10-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 11: Type 4 | 0 participants |
| Volixibat 2-5-10-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 1: Type 5 | 1 participants |
| Volixibat 2-5-10-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 5: Type 5 | 1 participants |
| Volixibat 2-5-10-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 6: Type 5 | 1 participants |
| Volixibat 2-5-10-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 3: Type 7 | 2 participants |
| Volixibat 2-5-10-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day -1: Type 2 | 1 participants |
| Volixibat 2-5-10-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 9: Type 1 | 0 participants |
| Volixibat 2-5-10-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 12: Type 1 | 0 participants |
| Volixibat 2-5-10-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 12: Type 6 | 8 participants |
| Volixibat 2-5-10-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 3: Type 6 | 4 participants |
| Volixibat 2-5-10-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 3: Type 1 | 1 participants |
| Volixibat 2-5-10-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 12: Type 3 | 0 participants |
| Volixibat 2-5-10-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day -1: Type 6 | 1 participants |
| Volixibat 2-5-10-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 4: Type 3 | 0 participants |
| Volixibat 2-5-10-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 5: Type 6 | 6 participants |
| Volixibat 2-5-10-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day -1: Type 3 | 1 participants |
| Volixibat 2-5-10-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 2: Type 7 | 0 participants |
| Volixibat 2-5-10-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 6: Type 2 | 0 participants |
| Volixibat 2-5-10-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 13: Type 7 | 0 participants |
| Volixibat 2-5-10-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 9: Type 3 | 0 participants |
| Volixibat 2-5-10-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 9: Type 2 | 0 participants |
| Volixibat 2-5-10-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 7: Type 4 | 0 participants |
| Volixibat 2-5-10-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 13: Type 6 | 2 participants |
| Volixibat 2-5-10-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 12: Type 2 | 0 participants |
| Volixibat 2-5-10-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 6: Type 3 | 0 participants |
| Volixibat 2-5-10-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 2: Type 6 | 6 participants |
| Volixibat 2-5-10-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 8: Type 2 | 0 participants |
| Volixibat 2-5-10-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 9: Type 4 | 0 participants |
| Volixibat 2-5-10-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day -1: Type 5 | 0 participants |
| Volixibat 2-5-10-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 6: Type 6 | 7 participants |
| Volixibat 2-5-10-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 4: Type 7 | 3 participants |
| Volixibat 2-5-10-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 11: Type 5 | 0 participants |
| Volixibat 2-5-10-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 5: Type 1 | 0 participants |
| Volixibat 2-5-10-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 12: Type 7 | 0 participants |
| Volixibat 2-5-10-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 13: Type 5 | 0 participants |
| Volixibat 2-5-10-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 9: Type 5 | 1 participants |
| Volixibat 2-5-10-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 5: Type 3 | 0 participants |
| Volixibat 2-5-10-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 8: Type 1 | 0 participants |
| Volixibat 2-5-10-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 14: Type 6 | 1 participants |
| Volixibat 2-5-10-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 2: Type 5 | 1 participants |
| Volixibat 2-5-10-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day -2: Type 5 | 0 participants |
| Volixibat 2-5-10-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 7: Type 1 | 0 participants |
| Volixibat 2-5-10-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 4: Type 6 | 4 participants |
| Volixibat 2-5-10-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 9: Type 6 | 6 participants |
| Volixibat 2-5-10-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 14: Type 4 | 3 participants |
| Volixibat 2-5-10-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 4: Type 2 | 0 participants |
| Volixibat 2-5-10-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 11: Type 3 | 0 participants |
| Volixibat 2-5-10-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 8: Type 3 | 0 participants |
| Volixibat 2-5-10-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 2: Type 4 | 0 participants |
| Volixibat 2-5-10-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 1: Type 1 | 1 participants |
| Volixibat 2-5-10-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 12: Type 4 | 0 participants |
| Volixibat 2-5-10-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 9: Type 7 | 1 participants |
| Volixibat 2-5-10-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 14: Type 5 | 0 participants |
| Volixibat 2-5-10-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 7: Type 5 | 1 participants |
| Volixibat 2-5-10-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 13: Type 4 | 2 participants |
| Volixibat 2-5-10-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 3: Type 5 | 2 participants |
| Volixibat 2-5-10-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 6: Type 1 | 0 participants |
| Volixibat 2-5-10-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 2: Type 3 | 0 participants |
| Volixibat 2-5-10-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day -2: Type 6 | 1 participants |
| Volixibat 2-5-10-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 10: Type 1 | 0 participants |
| Volixibat 2-5-10-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 4: Type 4 | 0 participants |
| Volixibat 2-5-10-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 11: Type 6 | 7 participants |
| Volixibat 2-5-10-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 8: Type 4 | 1 participants |
| Volixibat 2-5-10-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 7: Type 7 | 1 participants |
| Volixibat 2-5-10-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day -2: Type 4 | 3 participants |
| Volixibat 2-5-10-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 13: Type 3 | 1 participants |
| Volixibat 2-5-10-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 11: Type 1 | 0 participants |
| Volixibat 2-5-10-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 14: Type 3 | 2 participants |
| Volixibat 2-5-10-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 10: Type 2 | 0 participants |
| Volixibat 2-5-10-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 5: Type 4 | 0 participants |
| Volixibat 2-5-10-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 6: Type 4 | 0 participants |
| Volixibat 2-5-10-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day -2: Type 7 | 0 participants |
| Volixibat 2-5-10-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 2: Type 2 | 0 participants |
| Volixibat 2-5-10-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day -1: Type 4 | 3 participants |
| Volixibat 2-5-10-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 6: Type 7 | 1 participants |
| Volixibat 2-5-10-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day -2: Type 2 | 1 participants |
| Volixibat 2-5-10-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 10: Type 3 | 0 participants |
| Volixibat 2-5-10-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 8: Type 5 | 2 participants |
| Volixibat 2-5-10-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 1: Type 4 | 0 participants |
| Volixibat 2-5-10-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 13: Type 2 | 0 participants |
| Volixibat 2-5-10-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day -2: Type 3 | 3 participants |
| Volixibat 2-5-10-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 2: Type 1 | 0 participants |
| Volixibat 2-5-10-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 1: Type 3 | 0 participants |
| Volixibat 2-5-10-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 14: Type 1 | 1 participants |
| Volixibat 2-5-10-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 10: Type 4 | 0 participants |
| Volixibat 2-5-10-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day -1: Type 7 | 0 participants |
| Volixibat 2-5-10-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 7: Type 6 | 6 participants |
| Volixibat 2-5-10-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 3: Type 3 | 0 participants |
| Volixibat 2-5-10-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 12: Type 5 | 1 participants |
| Volixibat 2-5-10-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 1: Type 7 | 0 participants |
| Volixibat 2-5-10-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 3: Type 4 | 0 participants |
| Volixibat 2-5-10-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 10: Type 5 | 0 participants |
| Volixibat 2-5-10-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 8: Type 6 | 3 participants |
| Volixibat 2-5-10-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 11: Type 7 | 1 participants |
| Volixibat 2-5-10-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 13: Type 1 | 0 participants |
| Volixibat 2-5-10-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day -1: Type 1 | 1 participants |
| Volixibat 2-5-10-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 4: Type 5 | 0 participants |
| Volixibat 2-5-10-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 7: Type 3 | 0 participants |
| Volixibat 2-5-10-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day -2: Type 1 | 0 participants |
| Volixibat 2-5-10-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 10: Type 6 | 7 participants |
| Volixibat 2-5-10-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 5: Type 7 | 1 participants |
| Volixibat 2-5-10-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 4: Type 1 | 1 participants |
| Volixibat 2-5-10-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 14: Type 7 | 0 participants |
| Volixibat 2-5-10-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 1: Type 6 | 5 participants |
| Volixibat 2-5-10-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 7: Type 2 | 0 participants |
| Volixibat 2-5-10-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 5: Type 2 | 0 participants |
| Volixibat 2-5-10-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 1: Type 2 | 1 participants |
| Volixibat 2-5-10-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 10: Type 7 | 1 participants |
| Volixibat 2-5-10-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 3: Type 2 | 0 participants |
| Volixibat 30 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 10: Type 7 | 1 participants |
| Volixibat 30 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 1: Type 5 | 0 participants |
| Volixibat 30 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day -1: Type 2 | 1 participants |
| Volixibat 30 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 11: Type 1 | 0 participants |
| Volixibat 30 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 14: Type 1 | 0 participants |
| Volixibat 30 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 12: Type 6 | 6 participants |
| Volixibat 30 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 1: Type 4 | 0 participants |
| Volixibat 30 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 11: Type 2 | 0 participants |
| Volixibat 30 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 7: Type 7 | 0 participants |
| Volixibat 30 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 1: Type 3 | 2 participants |
| Volixibat 30 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 11: Type 3 | 0 participants |
| Volixibat 30 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 6: Type 3 | 0 participants |
| Volixibat 30 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 12: Type 5 | 0 participants |
| Volixibat 30 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 3: Type 7 | 0 participants |
| Volixibat 30 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 14: Type 4 | 3 participants |
| Volixibat 30 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 11: Type 4 | 0 participants |
| Volixibat 30 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 14: Type 5 | 1 participants |
| Volixibat 30 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 1: Type 2 | 0 participants |
| Volixibat 30 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day -1: Type 3 | 1 participants |
| Volixibat 30 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 4: Type 6 | 8 participants |
| Volixibat 30 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 11: Type 5 | 0 participants |
| Volixibat 30 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 12: Type 4 | 0 participants |
| Volixibat 30 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 1: Type 1 | 0 participants |
| Volixibat 30 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 11: Type 6 | 8 participants |
| Volixibat 30 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 8: Type 1 | 0 participants |
| Volixibat 30 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day -2: Type 3 | 1 participants |
| Volixibat 30 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day -1: Type 7 | 0 participants |
| Volixibat 30 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 5: Type 2 | 0 participants |
| Volixibat 30 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 11: Type 7 | 1 participants |
| Volixibat 30 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day -1: Type 4 | 3 participants |
| Volixibat 30 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 12: Type 3 | 0 participants |
| Volixibat 30 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 3: Type 6 | 7 participants |
| Volixibat 30 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day -1: Type 6 | 2 participants |
| Volixibat 30 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 9: Type 2 | 0 participants |
| Volixibat 30 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 12: Type 1 | 1 participants |
| Volixibat 30 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 14: Type 7 | 0 participants |
| Volixibat 30 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 12: Type 2 | 0 participants |
| Volixibat 30 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day -1: Type 5 | 1 participants |
| Volixibat 30 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 8: Type 2 | 0 participants |
| Volixibat 30 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 7: Type 2 | 0 participants |
| Volixibat 30 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 5: Type 3 | 0 participants |
| Volixibat 30 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 3: Type 5 | 0 participants |
| Volixibat 30 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 4: Type 7 | 0 participants |
| Volixibat 30 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 8: Type 3 | 0 participants |
| Volixibat 30 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 4: Type 4 | 0 participants |
| Volixibat 30 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 6: Type 1 | 0 participants |
| Volixibat 30 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day -2: Type 2 | 3 participants |
| Volixibat 30 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 6: Type 5 | 0 participants |
| Volixibat 30 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 3: Type 4 | 2 participants |
| Volixibat 30 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 8: Type 4 | 0 participants |
| Volixibat 30 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 8: Type 5 | 1 participants |
| Volixibat 30 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 5: Type 4 | 0 participants |
| Volixibat 30 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 3: Type 3 | 0 participants |
| Volixibat 30 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 5: Type 7 | 1 participants |
| Volixibat 30 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 8: Type 6 | 7 participants |
| Volixibat 30 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 7: Type 3 | 0 participants |
| Volixibat 30 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 3: Type 2 | 0 participants |
| Volixibat 30 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 8: Type 7 | 1 participants |
| Volixibat 30 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 6: Type 6 | 6 participants |
| Volixibat 30 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 6: Type 2 | 0 participants |
| Volixibat 30 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 3: Type 1 | 0 participants |
| Volixibat 30 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 14: Type 2 | 3 participants |
| Volixibat 30 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 9: Type 1 | 0 participants |
| Volixibat 30 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 6: Type 7 | 1 participants |
| Volixibat 30 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 5: Type 5 | 1 participants |
| Volixibat 30 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 5: Type 6 | 5 participants |
| Volixibat 30 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 4: Type 3 | 0 participants |
| Volixibat 30 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 2: Type 7 | 0 participants |
| Volixibat 30 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 13: Type 6 | 0 participants |
| Volixibat 30 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 9: Type 3 | 0 participants |
| Volixibat 30 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 7: Type 4 | 1 participants |
| Volixibat 30 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 2: Type 6 | 7 participants |
| Volixibat 30 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 14: Type 6 | 0 participants |
| Volixibat 30 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 9: Type 4 | 1 participants |
| Volixibat 30 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day -2: Type 4 | 0 participants |
| Volixibat 30 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 13: Type 5 | 0 participants |
| Volixibat 30 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 2: Type 5 | 0 participants |
| Volixibat 30 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 9: Type 5 | 0 participants |
| Volixibat 30 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 5: Type 1 | 0 participants |
| Volixibat 30 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 4: Type 2 | 0 participants |
| Volixibat 30 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 9: Type 6 | 7 participants |
| Volixibat 30 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day -2: Type 5 | 1 participants |
| Volixibat 30 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 2: Type 4 | 1 participants |
| Volixibat 30 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 13: Type 4 | 0 participants |
| Volixibat 30 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day -2: Type 1 | 0 participants |
| Volixibat 30 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 9: Type 7 | 1 participants |
| Volixibat 30 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 7: Type 5 | 1 participants |
| Volixibat 30 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 2: Type 3 | 1 participants |
| Volixibat 30 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 10: Type 1 | 0 participants |
| Volixibat 30 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 7: Type 1 | 0 participants |
| Volixibat 30 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day -2: Type 6 | 3 participants |
| Volixibat 30 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 13: Type 3 | 1 participants |
| Volixibat 30 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 6: Type 4 | 1 participants |
| Volixibat 30 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 2: Type 2 | 0 participants |
| Volixibat 30 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 10: Type 2 | 0 participants |
| Volixibat 30 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 13: Type 2 | 0 participants |
| Volixibat 30 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 14: Type 3 | 2 participants |
| Volixibat 30 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 10: Type 3 | 0 participants |
| Volixibat 30 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 4: Type 1 | 0 participants |
| Volixibat 30 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 2: Type 1 | 0 participants |
| Volixibat 30 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day -2: Type 7 | 0 participants |
| Volixibat 30 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 10: Type 4 | 0 participants |
| Volixibat 30 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 7: Type 6 | 7 participants |
| Volixibat 30 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 1: Type 7 | 2 participants |
| Volixibat 30 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 13: Type 1 | 0 participants |
| Volixibat 30 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 10: Type 5 | 0 participants |
| Volixibat 30 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 13: Type 7 | 0 participants |
| Volixibat 30 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 1: Type 6 | 5 participants |
| Volixibat 30 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 10: Type 6 | 8 participants |
| Volixibat 30 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day -1: Type 1 | 0 participants |
| Volixibat 30 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 12: Type 7 | 1 participants |
| Volixibat 30 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 4: Type 5 | 1 participants |
| Volixibat 40 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 11: Type 7 | 5 participants |
| Volixibat 40 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 6: Type 7 | 5 participants |
| Volixibat 40 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 4: Type 5 | 0 participants |
| Volixibat 40 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 7: Type 1 | 0 participants |
| Volixibat 40 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 4: Type 4 | 1 participants |
| Volixibat 40 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 7: Type 2 | 0 participants |
| Volixibat 40 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 7: Type 3 | 0 participants |
| Volixibat 40 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 4: Type 3 | 0 participants |
| Volixibat 40 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 7: Type 4 | 0 participants |
| Volixibat 40 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 4: Type 2 | 0 participants |
| Volixibat 40 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 7: Type 5 | 0 participants |
| Volixibat 40 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 4: Type 1 | 0 participants |
| Volixibat 40 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 7: Type 6 | 5 participants |
| Volixibat 40 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 3: Type 7 | 1 participants |
| Volixibat 40 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 7: Type 7 | 3 participants |
| Volixibat 40 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 14: Type 1 | 0 participants |
| Volixibat 40 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 8: Type 1 | 0 participants |
| Volixibat 40 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 3: Type 6 | 4 participants |
| Volixibat 40 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 8: Type 2 | 0 participants |
| Volixibat 40 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 3: Type 5 | 1 participants |
| Volixibat 40 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day -2: Type 2 | 0 participants |
| Volixibat 40 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 8: Type 3 | 0 participants |
| Volixibat 40 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 3: Type 4 | 0 participants |
| Volixibat 40 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 8: Type 4 | 0 participants |
| Volixibat 40 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 3: Type 3 | 1 participants |
| Volixibat 40 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 8: Type 5 | 1 participants |
| Volixibat 40 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 8: Type 6 | 5 participants |
| Volixibat 40 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 3: Type 2 | 0 participants |
| Volixibat 40 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 8: Type 7 | 2 participants |
| Volixibat 40 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 3: Type 1 | 0 participants |
| Volixibat 40 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 9: Type 1 | 0 participants |
| Volixibat 40 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 2: Type 7 | 1 participants |
| Volixibat 40 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 9: Type 2 | 0 participants |
| Volixibat 40 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 14: Type 2 | 1 participants |
| Volixibat 40 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 9: Type 3 | 0 participants |
| Volixibat 40 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 2: Type 6 | 5 participants |
| Volixibat 40 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 9: Type 4 | 0 participants |
| Volixibat 40 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 2: Type 5 | 0 participants |
| Volixibat 40 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 9: Type 5 | 0 participants |
| Volixibat 40 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 2: Type 4 | 1 participants |
| Volixibat 40 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day -2: Type 1 | 0 participants |
| Volixibat 40 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 9: Type 6 | 7 participants |
| Volixibat 40 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 9: Type 7 | 1 participants |
| Volixibat 40 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 2: Type 3 | 0 participants |
| Volixibat 40 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 10: Type 1 | 0 participants |
| Volixibat 40 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 2: Type 2 | 0 participants |
| Volixibat 40 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 10: Type 2 | 0 participants |
| Volixibat 40 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 2: Type 1 | 0 participants |
| Volixibat 40 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 10: Type 3 | 0 participants |
| Volixibat 40 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 14: Type 3 | 1 participants |
| Volixibat 40 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 10: Type 4 | 0 participants |
| Volixibat 40 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 1: Type 7 | 3 participants |
| Volixibat 40 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 10: Type 5 | 0 participants |
| Volixibat 40 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 1: Type 6 | 4 participants |
| Volixibat 40 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 10: Type 6 | 3 participants |
| Volixibat 40 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 1: Type 5 | 0 participants |
| Volixibat 40 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 10: Type 7 | 4 participants |
| Volixibat 40 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 11: Type 1 | 0 participants |
| Volixibat 40 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 1: Type 4 | 1 participants |
| Volixibat 40 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 11: Type 2 | 0 participants |
| Volixibat 40 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 1: Type 3 | 0 participants |
| Volixibat 40 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 11: Type 3 | 0 participants |
| Volixibat 40 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 1: Type 2 | 0 participants |
| Volixibat 40 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 11: Type 4 | 0 participants |
| Volixibat 40 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 1: Type 1 | 0 participants |
| Volixibat 40 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 14: Type 4 | 2 participants |
| Volixibat 40 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 11: Type 5 | 1 participants |
| Volixibat 40 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 11: Type 6 | 2 participants |
| Volixibat 40 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day -1: Type 7 | 0 participants |
| Volixibat 40 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 14: Type 6 | 1 participants |
| Volixibat 40 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 13: Type 7 | 0 participants |
| Volixibat 40 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day -1: Type 6 | 2 participants |
| Volixibat 40 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 12: Type 1 | 0 participants |
| Volixibat 40 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day -1: Type 5 | 0 participants |
| Volixibat 40 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 12: Type 2 | 0 participants |
| Volixibat 40 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 12: Type 3 | 0 participants |
| Volixibat 40 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day -1: Type 4 | 3 participants |
| Volixibat 40 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 12: Type 4 | 0 participants |
| Volixibat 40 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day -1: Type 3 | 1 participants |
| Volixibat 40 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 12: Type 5 | 0 participants |
| Volixibat 40 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day -1: Type 2 | 1 participants |
| Volixibat 40 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 14: Type 5 | 1 participants |
| Volixibat 40 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 12: Type 6 | 5 participants |
| Volixibat 40 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 12: Type 7 | 3 participants |
| Volixibat 40 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day -1: Type 1 | 1 participants |
| Volixibat 40 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 6: Type 5 | 0 participants |
| Volixibat 40 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 13: Type 1 | 0 participants |
| Volixibat 40 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day -2: Type 7 | 0 participants |
| Volixibat 40 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 13: Type 2 | 0 participants |
| Volixibat 40 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day -2: Type 6 | 4 participants |
| Volixibat 40 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 13: Type 3 | 0 participants |
| Volixibat 40 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 14: Type 7 | 0 participants |
| Volixibat 40 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 13: Type 4 | 2 participants |
| Volixibat 40 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day -2: Type 5 | 1 participants |
| Volixibat 40 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 13: Type 5 | 0 participants |
| Volixibat 40 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day -2: Type 4 | 2 participants |
| Volixibat 40 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 5: Type 5 | 0 participants |
| Volixibat 40 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 13: Type 6 | 3 participants |
| Volixibat 40 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 5: Type 6 | 5 participants |
| Volixibat 40 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 5: Type 7 | 3 participants |
| Volixibat 40 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 5: Type 4 | 0 participants |
| Volixibat 40 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 6: Type 1 | 0 participants |
| Volixibat 40 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 5: Type 3 | 0 participants |
| Volixibat 40 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 6: Type 2 | 0 participants |
| Volixibat 40 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 5: Type 2 | 0 participants |
| Volixibat 40 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day -2: Type 3 | 1 participants |
| Volixibat 40 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 6: Type 3 | 0 participants |
| Volixibat 40 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 5: Type 1 | 0 participants |
| Volixibat 40 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 6: Type 4 | 0 participants |
| Volixibat 40 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 4: Type 7 | 2 participants |
| Volixibat 40 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 6: Type 6 | 3 participants |
| Volixibat 40 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 4: Type 6 | 5 participants |
| Volixibat 80-40-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 7: Type 7 | 0 participants |
| Volixibat 80-40-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 12: Type 7 | 0 participants |
| Volixibat 80-40-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 4: Type 5 | 0 participants |
| Volixibat 80-40-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 10: Type 6 | 5 participants |
| Volixibat 80-40-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 1: Type 6 | 4 participants |
| Volixibat 80-40-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 6: Type 3 | 0 participants |
| Volixibat 80-40-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 10: Type 5 | 1 participants |
| Volixibat 80-40-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 14: Type 3 | 2 participants |
| Volixibat 80-40-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 3: Type 7 | 1 participants |
| Volixibat 80-40-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 13: Type 1 | 0 participants |
| Volixibat 80-40-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day -2: Type 7 | 0 participants |
| Volixibat 80-40-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 5: Type 1 | 0 participants |
| Volixibat 80-40-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 1: Type 7 | 1 participants |
| Volixibat 80-40-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 5: Type 6 | 8 participants |
| Volixibat 80-40-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 10: Type 3 | 0 participants |
| Volixibat 80-40-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 2: Type 1 | 0 participants |
| Volixibat 80-40-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 6: Type 7 | 0 participants |
| Volixibat 80-40-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 13: Type 2 | 1 participants |
| Volixibat 80-40-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 10: Type 2 | 0 participants |
| Volixibat 80-40-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day -2: Type 6 | 0 participants |
| Volixibat 80-40-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 7: Type 6 | 6 participants |
| Volixibat 80-40-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 5: Type 3 | 0 participants |
| Volixibat 80-40-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 10: Type 4 | 0 participants |
| Volixibat 80-40-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 2: Type 2 | 1 participants |
| Volixibat 80-40-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 4: Type 1 | 0 participants |
| Volixibat 80-40-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 13: Type 3 | 0 participants |
| Volixibat 80-40-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 10: Type 1 | 0 participants |
| Volixibat 80-40-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 14: Type 7 | 0 participants |
| Volixibat 80-40-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day -2: Type 5 | 1 participants |
| Volixibat 80-40-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 7: Type 5 | 1 participants |
| Volixibat 80-40-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 9: Type 7 | 2 participants |
| Volixibat 80-40-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 2: Type 3 | 1 participants |
| Volixibat 80-40-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 6: Type 6 | 7 participants |
| Volixibat 80-40-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 13: Type 4 | 0 participants |
| Volixibat 80-40-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 6: Type 4 | 0 participants |
| Volixibat 80-40-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 9: Type 6 | 5 participants |
| Volixibat 80-40-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 2: Type 4 | 0 participants |
| Volixibat 80-40-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 9: Type 5 | 0 participants |
| Volixibat 80-40-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day -2: Type 1 | 1 participants |
| Volixibat 80-40-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 2: Type 5 | 1 participants |
| Volixibat 80-40-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 4: Type 2 | 0 participants |
| Volixibat 80-40-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 13: Type 5 | 0 participants |
| Volixibat 80-40-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day -2: Type 4 | 4 participants |
| Volixibat 80-40-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 7: Type 4 | 0 participants |
| Volixibat 80-40-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 9: Type 4 | 0 participants |
| Volixibat 80-40-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 14: Type 2 | 4 participants |
| Volixibat 80-40-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 9: Type 3 | 0 participants |
| Volixibat 80-40-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 2: Type 6 | 4 participants |
| Volixibat 80-40-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 5: Type 5 | 0 participants |
| Volixibat 80-40-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 4: Type 7 | 1 participants |
| Volixibat 80-40-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day -2: Type 2 | 1 participants |
| Volixibat 80-40-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 9: Type 2 | 0 participants |
| Volixibat 80-40-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 2: Type 7 | 2 participants |
| Volixibat 80-40-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 7: Type 3 | 0 participants |
| Volixibat 80-40-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 9: Type 1 | 0 participants |
| Volixibat 80-40-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 3: Type 1 | 0 participants |
| Volixibat 80-40-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 5: Type 4 | 0 participants |
| Volixibat 80-40-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 8: Type 7 | 1 participants |
| Volixibat 80-40-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 13: Type 6 | 1 participants |
| Volixibat 80-40-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 8: Type 6 | 6 participants |
| Volixibat 80-40-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 3: Type 2 | 1 participants |
| Volixibat 80-40-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 4: Type 3 | 0 participants |
| Volixibat 80-40-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 5: Type 7 | 0 participants |
| Volixibat 80-40-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 6: Type 5 | 1 participants |
| Volixibat 80-40-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 8: Type 5 | 0 participants |
| Volixibat 80-40-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 3: Type 3 | 0 participants |
| Volixibat 80-40-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 8: Type 4 | 0 participants |
| Volixibat 80-40-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 3: Type 4 | 0 participants |
| Volixibat 80-40-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 8: Type 3 | 0 participants |
| Volixibat 80-40-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 4: Type 6 | 7 participants |
| Volixibat 80-40-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 6: Type 1 | 0 participants |
| Volixibat 80-40-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 7: Type 2 | 0 participants |
| Volixibat 80-40-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 3: Type 5 | 0 participants |
| Volixibat 80-40-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 8: Type 2 | 0 participants |
| Volixibat 80-40-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day -2: Type 3 | 1 participants |
| Volixibat 80-40-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 12: Type 2 | 0 participants |
| Volixibat 80-40-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day -1: Type 4 | 1 participants |
| Volixibat 80-40-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day -1: Type 5 | 0 participants |
| Volixibat 80-40-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 12: Type 1 | 0 participants |
| Volixibat 80-40-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day -1: Type 6 | 0 participants |
| Volixibat 80-40-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 14: Type 1 | 0 participants |
| Volixibat 80-40-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 12: Type 3 | 0 participants |
| Volixibat 80-40-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 4: Type 4 | 0 participants |
| Volixibat 80-40-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 11: Type 7 | 1 participants |
| Volixibat 80-40-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 11: Type 6 | 6 participants |
| Volixibat 80-40-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 14: Type 4 | 1 participants |
| Volixibat 80-40-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day -1: Type 7 | 1 participants |
| Volixibat 80-40-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 11: Type 5 | 1 participants |
| Volixibat 80-40-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 6: Type 2 | 0 participants |
| Volixibat 80-40-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 12: Type 4 | 0 participants |
| Volixibat 80-40-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day -1: Type 3 | 1 participants |
| Volixibat 80-40-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 5: Type 2 | 0 participants |
| Volixibat 80-40-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 1: Type 1 | 1 participants |
| Volixibat 80-40-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 11: Type 4 | 0 participants |
| Volixibat 80-40-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 1: Type 2 | 1 participants |
| Volixibat 80-40-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 11: Type 3 | 0 participants |
| Volixibat 80-40-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 7: Type 1 | 0 participants |
| Volixibat 80-40-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 12: Type 5 | 0 participants |
| Volixibat 80-40-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 1: Type 3 | 0 participants |
| Volixibat 80-40-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day -1: Type 2 | 2 participants |
| Volixibat 80-40-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 8: Type 1 | 0 participants |
| Volixibat 80-40-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 13: Type 7 | 0 participants |
| Volixibat 80-40-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 11: Type 2 | 0 participants |
| Volixibat 80-40-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 11: Type 1 | 0 participants |
| Volixibat 80-40-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 3: Type 6 | 7 participants |
| Volixibat 80-40-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 12: Type 6 | 8 participants |
| Volixibat 80-40-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 14: Type 6 | 1 participants |
| Volixibat 80-40-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 1: Type 4 | 1 participants |
| Volixibat 80-40-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day -1: Type 1 | 1 participants |
| Volixibat 80-40-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 14: Type 5 | 0 participants |
| Volixibat 80-40-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 10: Type 7 | 0 participants |
| Volixibat 80-40-20 mg QD | Number of Participants With Stool Hardness Using Bristol Stool Chart | Day 1: Type 5 | 1 participants |