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=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
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=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)
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=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 Evaluate Severe Hepatic Impairment on Dacomitinib PK
Severe Hepatic Impairment
Primary: Maximum Observed Plasma Concentration (Cmax) of Dacomitinib — 9.673; 7.389 nanogram per milliliter
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)
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=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 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 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 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=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…
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=16 Pharmacokinetics of Efavirenz in HIV-1 Infected Subjects With Hepatic Impairment
HIV Infections · Hepatic Impairment
Primary: Maximum Plasma Concentration (Cmax) — 5.303; 8.964; 6.750; 6.515 micrograms (mcg)/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 1 N=24 STUDY OF PF-06882961 IN PARTICIPANTS WITH AND WITHOUT VARYING DEGREES OF HEPATIC IMPAIREMENT
Hepatic Impairment · Healthy Volunteers
Primary: Maximum Plasma Concentration (Cmax) — 23.56; 31.37; 51.82; 78.73 nanogram per milliliter (ng/mL)
Phase 1 N=18 Tepotinib Hepatic Impairment Trial
Hepatic Impairment
Primary: Area Under the Plasma Concentration Time Curve From Time Zero to Infinity ( AUC0-inf ) of Tepotinib — 27500; 26100; 24200 Nanogram*hour per milliliter (ng*h/mL)
Early Phase 1 N=16 Study of Pexidartinib in Participants With Moderate Hepatic Impairment Compared With Healthy Participants
Moderate Hepatic Impairment
Primary: Maximum Plasma Concentration (Cmax) of Pexidartinib Following a Single Dose in Participants With Moderate Hepatic Impairment Compared to Healthy Participants — 1420…
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
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 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=30 Study of Copanlisib in Hepatic or Renal Impairment
Hepatic Insufficiency, Renal Insufficiency
Primary: Maximum Observed Concentration (Cmax) of Copanlisib in Plasma. — 68.12; 71.09; 31.77; 49.20 μg/L
Phase 1 N=17 Study to Estimate the Effects of Hepatic Impairment on the Pharmacokinetics (PK) of PF-07321332
Hepatic Impairment
Primary: Maximum Observed Plasma Concentration (Cmax) of Plasma PF-07321332 — 1.886; 1.923 micrograms per milliliter (ug/mL)
Phase 1 N=40 Pharmacokinetics of BAF312 in Patients With Hepatic Impairment
Hepatic Impairment
Primary: Pharmacokinetic Parameters of BAF312 and Selected Metabolites: Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUCinf) — 68.3; 53.9; 73.7…
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=88 Hepatic Impairment Study For Crizotinib In Advanced Cancer Patients
Advanced Cancer
Primary: Area Under Plasma Concentration Time Curve From Time Zero to End of Dosing Interval (AUCtau) of Crizotinib: Cycle 2 Day 1 — 3552; 2712; 3238; 2305 nanogram*hour per…
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
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)