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
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Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
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=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)
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=16 Investigate the Influence of Severe Hepatic Impairment on the Pharmacokinetics of Acalabrutinib and Its Metabolite
Hepatic Impairment · Hepatic Insufficiency · Healthy Subjects
Primary: Plasma Acalabrutinib PK Parameters — 1167; 226.1; 1161; 220.0 ng*hr/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=12 Pharmacokinetics, Safety and Tolerability of Vortioxetine in Normal Hepatic Function or Severe Hepatic Impairment
Severe Hepatic Impairment
Primary: AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Vortioxetine — 166.955; 188.663 ng*hr/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=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=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)
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=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=31 Mild, Moderate and Severe Renal Impairment Study
Gout
Primary: Maximum Observed Plasma Concentration (Cmax) — 25.6; 29.0; 38.2; 16.7 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=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 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=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=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=11 Pharmacokinetic Study of Aztreonam-Avibactam in Severe Renal Impairment
Renal Insufficiency
Primary: Total Daily Area Under the Plasma Concentration-time Profile From Time 0 to 24 Hours at Steady-state (AUC0-24,ss) of Aztreonam (ATM) — 922.9; 733.5 Microgram*hour per…
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=20 Study to Evaluate the Pharmacokinetics of Tenofovir Alafenamide (TAF) in Adults With Normal Hepatic Function and Adults With Severe Hepatic Impairment
Hepatitis B Virus
Primary: Pharmacokinetic (PK) Parameter: AUCinf of Tenofovir Alafenamide (TAF), Its Metabolite Tenofovir (TFV) and Free (Unbound) TAF — 120.6; 228.2; 219.9; 304.0 h*ng/mL
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=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=24 A Study of the Pharmacokinetics of Uprifosbuvir (MK-3682) and Ruzasvir (MK-8408) in Participants With Moderate and Severe Hepatic Insufficiency (MK-3682-029)
Hepatitis C, Chronic
Primary: Area Under the Drug Plasma Concentration-Time Curve From Start of Dosing to Time of the Last Quantifiable Sample (AUC0-last) of Uprifosbuvir — 5.34; 8.02; 3.74 µM*hr
Phase 4 N=60 Pradaxa Study in Non-valvular Atrial Fibrillation Patients With Severely Impaired Renal Function
Atrial Fibrillation
Primary: Pre-dose Concentration of the Analyte in Plasma at Steady State Immediately Before Administration of the Next Dose — 155 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…
Phase 1 N=33 Pharmacokinetics of Voxilaprevir in Adults With Normal Hepatic Function and Moderate or Severe Hepatic Impairment
HCV Infection
Primary: Pharmacokinetic (PK) Parameter of Voxilaprevir: AUClast — 2058.5; 3872.5; 500.1; 601.2 h*ng/mL
Phase 1 N=17 Pharmacokinetic and Safety Study of Niraparib With Normal or Moderate Hepatic Impairment Patients
Ovarian Neoplasms · Neoplasms · Solid Tumor
Primary: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of Niraparib and Its Major Metabolite (M1) During…
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=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…