An Open-Label Study Following Oral Dosing of Seladelpar to Participants With Primary Biliary Cholangitis (PBC) and Hepatic Impairment (HI)
Phase 1
Completed
NCT04950764
| Condition | Primary Biliary Cholangitis, Compensated Cirrhosis, Hepatic Impairment |
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| Phase | Phase 1 |
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| Sponsor | Gilead Sciences |
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| Status | Completed |
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| Enrollment | 24 participants |
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| Interventions | Seladelpar |
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| Start date | Nov 16, 2021 |
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| Completion date | Feb 24, 2025 |
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| Results posted | May 4, 2026 |
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Summary
The Effect of Hepatic Impairment on The Pharmacokinetics of Seladelpar: An Open-Label Study Following Oral Dosing of Seladelpar to Participants with Primary Biliary Cholangitis (PBC) and Hepatic Impairment (HI)
Part A: Pharmacokinetic (PK) Parameter: Cmax of Seladelpar and Its Metabolites (M1, M2, and M3)
Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 and 72 hours postdose · nanograms per milliliter (ng/mL)
| Part A: Cohort 1 - CP-A Without PHT (Seladelpar 10 mg) | 182.0 ± 60.68 nanograms per milliliter (ng/mL) |
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| Part A: Cohort 2 - CP-A With PHT (Seladelpar 10 mg) | 367.7 ± 238.28 nanograms per milliliter (ng/mL) |
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| Part A: Cohort 3 - CP-B (Seladelpar 10 mg) | 359.2 ± 158.61 nanograms per milliliter (ng/mL) |
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| Part A: Cohort 4 - CP-C (Seladelpar 10 mg) | 388.5 ± 153.45 nanograms per milliliter (ng/mL) |
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| Part A: Cohort 1 - CP-A Without PHT (Seladelpar 10 mg) | 20.08 ± 9.012 nanograms per milliliter (ng/mL) |
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| Part A: Cohort 2 - CP-A With PHT (Seladelpar 10 mg) | 33.17 ± 9.913 nanograms per milliliter (ng/mL) |
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| Geometric Least-squares Mean Ratio | 183 (95% CI 114–295) |
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Part A: PK Parameter: Tmax of Seladelpar and Its Metabolites (M1, M2, and M3)
Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 and 72 hours postdose · hours (h)
| Part A: Cohort 1 - CP-A Without PHT (Seladelpar 10 mg) | 1.208 hours (h) |
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| Part A: Cohort 2 - CP-A With PHT (Seladelpar 10 mg) | 0.758 hours (h) |
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| Part A: Cohort 3 - CP-B (Seladelpar 10 mg) | 1.250 hours (h) |
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| Part A: Cohort 4 - CP-C (Seladelpar 10 mg) | 1.250 hours (h) |
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| Part A: Cohort 1 - CP-A Without PHT (Seladelpar 10 mg) | 4.000 hours (h) |
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| Part A: Cohort 2 - CP-A With PHT (Seladelpar 10 mg) | 4.500 hours (h) |
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Part A: PK Parameter: AUC0-t of Seladelpar and Its Metabolites (M1, M2, and M3)
Day 1: Predose; 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 and 72 hours postdose · h*ng/mL
| Part A: Cohort 1 - CP-A Without PHT (Seladelpar 10 mg) | 800 ± 214 h*ng/mL |
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| Part A: Cohort 2 - CP-A With PHT (Seladelpar 10 mg) | 1390 ± 504 h*ng/mL |
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| Part A: Cohort 3 - CP-B (Seladelpar 10 mg) | 1390 ± 812 h*ng/mL |
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| Part A: Cohort 4 - CP-C (Seladelpar 10 mg) | 1970 ± 416 h*ng/mL |
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| Part A: Cohort 1 - CP-A Without PHT (Seladelpar 10 mg) | 239 ± 41.3 h*ng/mL |
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| Part A: Cohort 2 - CP-A With PHT (Seladelpar 10 mg) | 324 ± 117 h*ng/mL |
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| Geometric Least-squares Mean Ratio | 171 (95% CI 124–235) |
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