Trial Outcomes & Findings for Steady-State Pharmacokinetics of Rifaximin 550 mg Tablets in Healthy and Hepatically Impaired Subjects (NCT NCT03818672)

NCT ID: NCT03818672

Last Updated: 2023-11-30

Results Overview

Maximum observed plasma concentration (Cmax) of rifaximin and 25-desacetyl rifaximin, if measurable

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 5 participants
• Primary outcome timeframe: 7 days
• Results posted on: 2023-11-30

Participant Flow

Participant milestones

Measure	Rifaximin Rifaximin 550 mg BID Rifaximin: Rifaximin 550 MG BID
Overall Study STARTED	5
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Steady-State Pharmacokinetics of Rifaximin 550 mg Tablets in Healthy and Hepatically Impaired Subjects

Baseline characteristics by cohort

Measure	Rifaximin n=5 Participants Rifaximin 550 mg BID Rifaximin: Rifaximin 550 MG BID
Age, Continuous	45.8 years STANDARD_DEVIATION 6.870 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Model for End Stage Liver Disease Score at baseline: Healthy	1 Participants n=5 Participants
Model for End Stage Liver Disease Score at baseline: 19 to 25	4 Participants n=5 Participants

PRIMARY outcome

Timeframe: 7 days

Population: 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.

Maximum observed plasma concentration (Cmax) of rifaximin and 25-desacetyl rifaximin, if measurable

Outcome measures

Measure	Rifaximin n=4 Participants Rifaximin 550 mg BID Rifaximin: Rifaximin 550 MG BID
Maximum Observed Plasma Concentration (Cmax) rifaximin	13.4 ng/mL Geometric Coefficient of Variation 90.0
Maximum Observed Plasma Concentration (Cmax) 25-desacetyl rifaximin	0.356 ng/mL Geometric Coefficient of Variation 87.5

PRIMARY outcome

Timeframe: 7 days

Population: 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.

Time of the maximum concentration (Tmax) of rifaximin and 25-desacetyl rifaximin, if measurable

Outcome measures

Measure	Rifaximin n=4 Participants Rifaximin 550 mg BID Rifaximin: Rifaximin 550 MG BID
Time of the Maximum Concentration (Tmax) 25-desacetyl rifaximin	0.625 hours Standard Deviation 0.750
Time of the Maximum Concentration (Tmax) rifaximin	0.688 hours Standard Deviation 0.688

PRIMARY outcome

Timeframe: 7 days

Population: 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.

Area under the plasma concentration versus time curve (AUC) during the 12-hour dose interval of rifaximin and 25-desacetyl rifaximin, if measurable

Outcome measures

Measure	Rifaximin n=4 Participants Rifaximin 550 mg BID Rifaximin: Rifaximin 550 MG BID
Area Under the Plasma Concentration Versus Time Curve (AUC) During the 12-hour Dose Interval rifaximin	98.7 h*ng/mL Geometric Coefficient of Variation 107
Area Under the Plasma Concentration Versus Time Curve (AUC) During the 12-hour Dose Interval 25-desacetyl rifaximin	3.04 h*ng/mL Geometric Coefficient of Variation 85.2

Adverse Events

Rifaximin

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Rifaximin n=5 participants at risk Rifaximin 550 mg BID Rifaximin: Rifaximin 550 MG BID
Gastrointestinal disorders Vomiting	20.0% 1/5 • 7 days
Injury, poisoning and procedural complications Tooth fracture	20.0% 1/5 • 7 days

Additional Information

Study Director

Bausch Health Americas, Inc

Phone: 7072851528

Email: Varsha.Bhatt@bauschhealth.com

Results disclosure agreements

• Principal investigator is a sponsor employee Contact sponsor for details.
• Publication restrictions are in place

Restriction type: OTHER