Phase 1 N=24 Study of PF-05221304 in Subjects With Varying Degrees of Hepatic Impairment
Hepatic Impairment
Primary: Maximum Plasma Concentration (Cmax) of PF-05221304 — 1220; 1591; 1433; 1592 Nanogram per milliliter (ng/mL)
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
Phase 1 N=24 An Open-Label Study Following Oral Dosing of Seladelpar to Participants With Primary Biliary Cholangitis (PBC) and Hepatic Impairment (HI)
Primary Biliary Cholangitis · Compensated Cirrhosis · Hepatic Impairment
Primary: Part A: Pharmacokinetic (PK) Parameter: Cmax of Seladelpar and Its Metabolites (M1, M2, and M3) — 182.0; 367.7; 359.2; 388.5 nanograms per milliliter (ng/mL)
Phase 1 N=16 Pharmacokinetics of BIA 9-1067 in Subjects With Hepatic Impairment
Parkinson's Disease
Primary: Cmax - Maximum Plasma Concentration of BIA 9-1067 — 1108; 559 ng/mL
Phase 2 N=35 BI 207127 / Faldaprevir Combination Therapy in Hepatic Impairment (Child-Pugh B) Patients With Genotype 1b Chronic Hepatitis C Infection: HCVerso3
Hepatitis C, Chronic
Primary: SVR12: Plasma HCV RNA Level Less Than 25 IU/mL at 12 Weeks After End of Treatment (EOT) — 61.1; 52.9 Percentage of participants
Phase 1 N=24 Evaluation Of Hepatic Impairment On AG-013736 Pharmacokinetics
Hepatic Insufficiency
Primary: Maximum Observed Plasma Concentration (Cmax) — 30.43; 26.96; 38.85 ng/mL
Phase 1 N=22 Pharmacokinetics Study of MCI-186 in Subjects With Mild or Moderate Hepatic Impairment
Hepatic Impairment · Healthy
Primary: Cmax — 538.1; 533.4; 429 ng/mL
Phase 4 N=10 The Effect of High Dose Vitamin C on the Liver Function in Chronic Hepatitis Patients
Chronic Hepatitis · Chronic Hepatitis C · Chronic Alcoholic Hepatitis
Primary: The Change in Serum Alanine Aminotransferase Level From Baseline to 12 Weeks — 77.5; 105.5 IU/L
Phase 1 N=24 A Hepatic Impairment Study for PF-04965842.
Hepatic Impairment
Primary: Maximum Observed Plasma Concentration (Cmax) for PF-04965842 — 1352; 1276; 1426 nanogram per milliliter (ng/mL)
Phase 1 N=38 A Study of The Effect of Hepatic Impairment on The Pharmacokinetics of Aleglitazar
Healthy Volunteer
Primary: Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUCinf) of Aleglitazar — 98.5; 113; 151 hours (h)*nanogram (ng)/milliliter (mL)
Phase 4 N=43 Single Dose Pharmacokinetics of Suboxone Study in Hepatic Impaired Subjects
Hepatic Failure · Hepatic Impairment · Chronic Hepatitis C Infection With Hepatic Coma
Primary: Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration (AUC0-last) of Buprenorphine, Norbuprenorphine, Naloxone and…
Phase 1 N=16 Daprodustat Hepatic Impairment Study
Anaemia
Primary: Part 1: Area Under the Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC [0-infinity]) of GSK1278863 and Its Metabolites — 296.2407…
Phase 1 N=57 Open-Label Study to Evaluate the Safety, Tolerability, and PK of Aramchol in Subjects With Hepatic Impairment
Hepatic Impairment
Primary: AUC0-tau, Steady State — 96100; 107000; 103000; 69500 h•ng/mL
Phase 3 N=95 Is Adrenal Insufficiency Under-diagnosed in Hospitalized Cirrhosis Patients?
Adrenal Insufficiency · Cirrhosis · Spur Cell Anemia
Primary: Number of Participants With Cholesterol Esterification Deficiency — 10; 11 Participants
Phase 1 N=12 PK Study in Subjects With Severe Hepatic Impairment
Severe Hepatic Impairment · Healthy
Primary: Pharmacokinetic Parameters of MCI-186: Peak Drug Concentration (Cmax) — 347.6; 280.3 ng/mL
N/A N=130 Quality of Life During Treatment of Chronic Hepatitis C (P05278/MK-4031-336)
Hepatitis C, Chronic · Genotype 1 · HCV-1
Primary: Change From Baseline (BL) to Week 72 (WK72) in 36-Item Short-Form Health Survey (SF-36) Scores — 87.27; 87.33; -1.56; 81.71 score on a scale
Phase 1 N=30 Single-Dose Pharmacokinetics of BMS-790052 in Participants With Hepatic Impairment
Hepatic Insufficiency
Primary: Maximum Observed Plasma Concentration (Cmax) of BMS-790052 — 380; 382; 317; 698 nanograms/milliliter (ng/mL)
N/A N=2,600 Chinese CLIF-C Acute-on-Chronic Liver Disease and Liver Failure Study
Liver Failure, Acute on Chronic
Primary: 28-day Mortality,28-day Liver-transplantation Free Mortality& 28-day Liver Transplantation Rate — 74; 124; 74 Participants
Phase 1 N=36 PK and PD Study of IDN-6556 in Subjects With Hepatic Impairment and Matched Healthy Volunteers
Hepatic Impairment · Liver Diseases · Digestive System Diseases
Primary: AUC — 113.5; 114.6; 423.7; 1042 h*ng/mL
N/A N=167 Fosamprenavir in Pts With Hepatic Impairment
Infection, Human Immunodeficiency Virus
Primary: Number of Events of ALT Elevation After Baseline, Controlling for APRI Score and Other Variables — 9; 4 events — p=0.02
Phase 1 N=33 Nintedanib in Volunteers With Hepatic Impairment Compared With Healthy Volunteers
Hepatic Insufficiency
Primary: AUC (0-inf) of Nintedanib — 200; 674; 92.7; 77.8 ng*h/mL
N/A N=28 Chronic Liver Disease in Urea Cycle Disorders
Urea Cycle Disorder
Primary: Liver Stiffness as Measured by Shear Wave Elastography — 13; 14 Participants
Phase 1 N=24 Effect of Hepatic Impairment on M2951 (BTK Inhibitor) PK
Hepatic Impairment
Primary: Area Under the Plasma Concentration Time Curve From Time Zero to Infinity (AUC0-inf) of M2951 — 186; 232; 362 hour*nanogram per milliliter (h*ng/mL)
Phase 1 N=42 A Study to Assess Pharmacokinetics of Preladenant in Participants With Chronic Hepatic Impairment (P06513)
Chronic Hepatic Impairment
Primary: Area Under the Plasma Concentration-time Curve From Time 0 Extrapolated to Time of the Last Quantifiable Concentration (AUC 0-t) of Preladenant After a Single Dose of…
Phase 1 N=35 Influence of Mild and Moderate Hepatic Impairment on the Pharmacokinetics, Safety and Tolerability of Various Doses of Afatinib
Liver Diseases · Healthy
Primary: Area Under Curve From 0 to Infinity (AUC0-infinity) — 886; 552; 934; 956 ng*h/mL — p=0.1998
Phase 1 N=16 Study of Nalbuphine ER in Participants With Hepatic Impairment
Hepatic Impairment
Primary: Part 1: Maximum Observed Plasma Concentration (Cmax) of NAL ER — 3.30; 7.67; 13.9; 18.7 nanogram per milliliter (ng/mL)
Phase 1 N=37 A Study of LY2140023 in Hepatically-Impaired Participants
Hepatic Insufficiency
Primary: Pharmacokinetics: Area Under the Concentration Time Curve (AUC) of LY2140023 and LY404039 — 1420; 1360; 836; 926 nanograms*hours per milliliter (ng*h/mL)
Phase 1 N=28 Effect of Hepatic Impairment on the Pharmacokinetics of Alectinib
Hepatic Impairment
Primary: Maximum Observed Plasma Concentration (Cmax) of Total Alectinib — 107; 83.6; 85.5; 85.1 nanograms per milliliter (ng/mL)
N/A N=48 Intra-Individual Reproducibility of the Non-Invasive Assessment of the Portal Circulation
Hepatitis C, Chronic · Non-Alcoholic Fatty Liver Disease
Primary: Cholate Shunt Test — 28.0; 37.6; 33.4 SHUNT %
Phase 1 N=24 Effect Of Hepatic Impairment on the Pharmacokinetics, Safety and Tolerability of PF-06865571 In Subjects With Hepatic Impairment and in Healthy Subjects
Hepatic Impairment · Healthy Volunteers
Primary: Maximum Observed Plasma Concentration (Cmax) — 532.2; 835.5; 668.3; 658.6 nanogram per milliliter (ng/mL)
Phase 4 N=21 An Open-label, Non-randomized, Parallel Group Study in Subjects With Mild and Moderate Hepatic Insufficiency and Healthy Volunteers
Hepatic Impairment
Primary: Cmax for Serum Deferiprone and Deferiprone 3-O-glucuronide — 49.00; 36.26; 35.94; 69.03 ug/mL