Hepatic Impairment Trial of Obeticholic Acid
Phase 1
Completed
- Conditions
- Hepatic Impairment
- Interventions
- Drug: obeticholic acid 10 mg
- Registration Number
- NCT01904539
- Lead Sponsor
- Intercept Pharmaceuticals
- Brief Summary
This is a phase 1 study to evaluate the safety of a single 10 mg dose of obeticholic acid (OCA) in healthy volunteers and patients with liver disease.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 32
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Severe Hepatic Impairment obeticholic acid 10 mg Subjects with severe hepatic impairment defined as Child-Pugh class C receiving obeticholic acid 10 mg. Mild Hepatic Impairment obeticholic acid 10 mg Subjects with mild hepatic impairment defined as Child-Pugh class A receiving a single dose of obeticholic acid 10mg. Moderate Hepatic Impairment obeticholic acid 10 mg Subjects with moderate hepatic impairment defined as Child-Pugh class B receiving obeticholic acid 10mg. Healthy Volunteer obeticholic acid 10 mg Healthy volunteers receiving a single dose of obeticholic acid 10 mg.
- Primary Outcome Measures
Name Time Method Peak plasma concentration (Cmax) of OCA and conjugates Up to 48 hours maximum concentration
Area under the concentration versus time curve from time 0 to the last sampling time with measurable analyte concentration (AUCt) of OCA and conjugates Post-dose 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, and 216 hours post-dose Time to Cmax (Tmax) of OCA and conjugates Up to 48 hours Area under the concentration versus time curve from time 0-24 hours with measurable analyte concentration of OCA and conjugates. (AUC 0-24) 24 hours
- Secondary Outcome Measures
Name Time Method Amount of OCA and conjugates excretion in urine -6to 0, 0 to 6, 6 to 12, 12 to 24, and 24 to 30 hours Total amount of OCA and conjugates excreted in urine 0 to 30 hours Protein Binding 0, 0.75, 1.5, 6, and 24 hours Urine concentration of unchanged OCA and conjugates 0, 6, 12, 24, 30 hours
Trial Locations
- Locations (2)
Clinical Pharmacology of Miami, Inc.
🇺🇸Miami, Florida, United States
Orlando Clinical Research Center
🇺🇸Orlando, Florida, United States
Clinical Pharmacology of Miami, Inc.🇺🇸Miami, Florida, United States