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Study determined to be infeasible.
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The primary objective of this study is to characterize the steady state plasma
The primary objective of this study is to characterize the steady state plasma PK of rifaximin (550 mg BID) in subjects with severe hepatic impairment (MELD 19 to 25 and MELD >25), as well as healthy subjects with normal hepatic function.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rifaximin | Experimental | Rifaximin 550 mg BID |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rifaximin | Drug | Rifaximin 550 MG BID |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) | Maximum observed plasma concentration (Cmax) of rifaximin and 25-desacetyl rifaximin, if measurable | 7 days |
| Time of the Maximum Concentration (Tmax) | Time of the maximum concentration (Tmax) of rifaximin and 25-desacetyl rifaximin, if measurable | 7 days |
| Area Under the Plasma Concentration Versus Time Curve (AUC) During the 12-hour Dose Interval | Area under the plasma concentration versus time curve (AUC) during the 12-hour dose interval of rifaximin and 25-desacetyl rifaximin, if measurable | 7 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Varsha Bhatt | Bausch Health Companies | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Valeant Site 01 | San Antonio | Texas | 78215 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Rifaximin | Rifaximin 550 mg BID Rifaximin: Rifaximin 550 MG BID |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Rifaximin | Rifaximin 550 mg BID Rifaximin: Rifaximin 550 MG BID |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Maximum Observed Plasma Concentration (Cmax) | Maximum observed plasma concentration (Cmax) of rifaximin and 25-desacetyl rifaximin, if measurable | Participants with Model for End Stage Liver Disease (MELD) of 19 to 25 (N=4) were assessed for pharmacokinetic parameters. There were too few healthy participants (N=1) to assess. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | 7 days |
|
|
7 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Rifaximin | Rifaximin 550 mg BID Rifaximin: Rifaximin 550 MG BID | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vomiting | Gastrointestinal disorders | MedDRA 21.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Bausch Health Americas, Inc | 7072851528 | Varsha.Bhatt@bauschhealth.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 8, 2018 | Nov 10, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000078262 | Rifaximin |
| ID | Term |
|---|---|
| D012294 | Rifamycins |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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open-label, repeat-dose, parallel-design study in 12 subjects with severe hepatic impairment and 6 healthy subjects with normal hepatic function.
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Model for End Stage Liver Disease Score at baseline: Healthy | MELD score was calculated based on laboratory results using the following formula: • (0.957 * ln(Serum Creatinine mg/dL) + 0.378 * ln(Serum Bilirubin mg/dL) + 1.120 * ln( international normalised ratio [INR] blood test ) + 0.643) * 10. | Count of Participants | Participants |
|
| Model for End Stage Liver Disease Score at baseline: 19 to 25 | MELD score was calculated based on laboratory results using the following formula: • (0.957 * ln(Serum Creatinine mg/dL) + 0.378 * ln(Serum Bilirubin mg/dL) + 1.120 * ln( international normalised ratio [INR] blood test ) + 0.643) * 10. | Count of Participants | Participants |
|
|
|
| Primary | Time of the Maximum Concentration (Tmax) | Time of the maximum concentration (Tmax) of rifaximin and 25-desacetyl rifaximin, if measurable | Participants with Model for End Stage Liver Disease (MELD) of 19 to 25 (N=4) were assessed for pharmacokinetic parameters. There were too few healthy participants (N=1) to assess. | Posted | Mean | Standard Deviation | hours | 7 days |
|
|
|
| Primary | Area Under the Plasma Concentration Versus Time Curve (AUC) During the 12-hour Dose Interval | Area under the plasma concentration versus time curve (AUC) during the 12-hour dose interval of rifaximin and 25-desacetyl rifaximin, if measurable | Participants with Model for End Stage Liver Disease (MELD) of 19 to 25 (N=4) were assessed for pharmacokinetic parameters. There were too few healthy participants (N=1) to assess. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | 7 days |
|
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| 5 |
| 0 |
| 5 |
| 2 |
| 5 |
| Tooth fracture | Injury, poisoning and procedural complications | MedDRA 21.0 | Non-systematic Assessment |
|
Contact sponsor for details.
| D047029 | Lactams, Macrocyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |