Clinical trials: Hepatic
Hepatic Impairment
Pharmacokinetics and Safety of Rupatadine in Participants With Hepatic Impairment Compared to Control Participants.
The purpose of this study is to assess the PK and safety of rupatadine (10 mg) and its active metabolites in participants with mild, moderate, or severe hepatic impairment compared to matched control participants with normal…
- Trial name
- NCT06736340
- Testing
- Rupatadine
- Where
- 7 sites in Portugal, Spain
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Noucor Health S.A.
Pharmacokinetics, Hepatic Impairment
MDMA in Subjects With Moderate Hepatic Impairment and Subjects With Normal Hepatic Function
The goal of this clinical trial to learn how MDMA is processed in people with abnormal liver function. The main questions it aims to answer are: Do people with abnormal liver function experience greater absorption of MDMA? Does…
- Trial name
- NCT03606538
- Testing
- Midomafetamine HCl
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Resilient Pharmaceuticals
Erythropoietic Protoporphyria
HELIOS: Open-Label, Long-Term Extension Study to Investigate the Safety, Tolerability, and Efficacy of DISC-1459 (Bitopertin) in Participants With EPP or XLP
This is an open-label, long-term extension study to investigate the safety, tolerability and efficacy of DISC-1459 in participants with EPP.
- Trial name
- NCT05883748
- Testing
- DISC-1459
- Where
- 26 sites in United States, Australia and 9 more
- Volunteers
- 230 people
- Sponsor
- Disc Medicine, Inc
Autism Spectrum Disorder
The Effect of Hepatic Impairment on the Pharmacokinetics of Balovaptan
This is a multi-center, non-randomized, open-label, parallel group, multiple-dose study to assess the pharmacokinetic, safety, and tolerability of balovaptan in male and female subjects with moderate hepatic impairment compared…
- Trial name
- NCT03912350
- Testing
- Balovaptan
- Volunteers
- healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Hepatic Impairment
A Phase 1 Open-Label Evaluation of the Pharmacokinetics and Safety of a Single Dose of Apraglutide in Subjects With Normal and Impaired Hepatic Function
The primary objective is to assess the pharmacokinetics (PK) of apraglutide in subjects with hepatic impairment compared with matched control subjects with normal hepatic function following single subcutaneous (SC) dose…
- Trial name
- NCT05706623
- Testing
- Apraglutide
- Where
- 2 sites in Germany, Slovakia
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- VectivBio AG
Hepatocarcinoma, Hepatic Metastasis
Robotic Endomicroscopy to Better Define Resection Strategies Applied to Hepatic Surgery
This study aims at assessing the feasibility of Probe-based Confocal Laser Endomicroscopy (pCLE) during laparoscopic hepatic masses resection for intra-operative characterisation of hepatic masses and surgical margins assessment.
- Conditions
- Hepatocarcinoma, Hepatic Metastasis, Hepatic Tumor
- Trial name
- PERSEE (NCT03718078)
- Testing
- Confocal Laser Endomicroscopy
- Where
- France
- Volunteers
- 40 people
- Sponsor
- Mauna Kea Technologies
Complement Mediated Primary or Secondary Glomerular Diseases
Investigation of Pharmacokinetics,Safety,and Pharmacodynamics of HRS-5965 in Subjects With Hepatic Impairment
The study is being conducted to compare the pharmacokinetics, safety, and pharmacodynamics of HRS-5965 in subjects with mild to moderate hepatic impairment and normal hepatic function.
- Trial name
- NCT06674915
- Testing
- HRS-5965 capsules
- Where
- China
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Chengdu Suncadia Medicine Co., Ltd.
Hepatic Impairment
A Trial to Evaluate the Pharmacokinetics of ABL001 in Healthy and Hepatic Impaired Subjects
The main purpose of this study is to evaluate the effect of varying degrees of impaired hepatic function (by Child-Pugh classification) on the pharmacokinetics (PK) of ABL001 after a single oral dose.
- Trial name
- NCT02857868
- Testing
- ABL001
- Where
- 3 sites in United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Variegate Porphyria
Study to Evaluate the Safety and Efficacy of Afamelanotide in Patients With Variegate Porphyria (VP)
The primary objective is to evaluate the impact of afamelanotide on the severity of skin disease in patients with Variegate Porphyria (VP).
- Trial name
- NCT05854784
- Testing
- Afamelanotide 16 MG
- Where
- Netherlands
- Volunteers
- 6 people
- Sponsor
- Clinuvel Pharmaceuticals Limited
HIV Infection, Hepatitis C
An Open Label Study To Evaluate The Safety and Kinetics of Nelfinavir in Subjects With HIV and Hepatitis C
The purpose of this study is to confirm the safety, efficacy and delineate the pharmacokinetic properties of nelfinavir in HIV/ Hepatitis C coinfected subjects with Child Pugh A compensated cirrhosis and or Hepatic fibrosis
- Trial name
- NCT00141284
- Testing
- nelfinavir 1,250 mg twice daily, Zidovudine 300 mg twice daily, Lamivudine 150 mg twice daily
- Where
- 5 sites in United States, Canada
- Volunteers
- 12 people
- Sponsor
- Pfizer
Advanced or Metastatic Solid Tumors in Patients With Hepatic Impairment
A Study in Cancer Patients With Hepatic Impairment to Evaluate the Pharmacokinetics and Safety of NKTR-102 (Etirinotecan Pegol)
The purpose of this study is to investigate the PK and safety of NKTR-102 in patients with mild, moderate, or severe hepatic impairment.
- Trial name
- NCT01991678
- Testing
- 145 mg/m2 NKTR 102, 120 mg/m2 NKTR 102, 50 mg/m2 NKTR 102
- Where
- 3 sites in United States
- Volunteers
- 25 people
- Sponsor
- Nektar Therapeutics
Liver Fibrosis, Hepatic Cirrhosis
A Study to Evaluate the Safety, Tolerability, PK, and PD Effects of AZD2389 in Participants With Liver Fibrosis and Compensated Cirrhosis.
The purpose of this study is to measure the safety, tolerability, and the way the body absorbs, distributes, and metabolises AZD2389 as compared to placebo in participants with liver fibrosis and compensated cirrhosis.
- Trial name
- BORANA (NCT06750276)
- Testing
- AZD2389
- Where
- 9 sites in United States, Puerto Rico and 1 more
- Volunteers
- 40 people
- Sponsor
- AstraZeneca
Diabetes, Healthy
A Trial Investigating the Pharmacokinetic (Mode of Action in the Body) and Safety Profiles of NN1250 (Insulin Degludec) in Subjects With Various Degrees of Impaired Liver Function and in Subjects With Normal Liver Function
This trial was conducted in Europe. The aim of this clinical trial was to evaluate if the pharmacokinetic and safety profiles of NN1250 (insulin degludec) are altered to such an extent that the dose should be adjusted in subjects…
- Trial name
- NCT00976326
- Testing
- insulin degludec
- Where
- Slovakia
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Novo Nordisk A/S
Hepatic Impairment, Healthy Volunteers
A Study to Evaluate the Effect of Hepatic Impairment on the Single Dose Pharmacokinetics (PK) of Intravenous TAK-954
The purpose of this study is to evaluate the effect of varying degrees of hepatic function on the single dose PK of IV TAK-954.
- Trial name
- NCT03277274
- Testing
- TAK-954
- Where
- 2 sites in Czechia, Slovakia
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Takeda
Liver Cancer
Feasibility of a Minimally Invasive Image-Guided Surgery System for Hepatic Procedures
This study was designed to confirm that the surgeon is able to perform surface registration of standard liver features used as landmarks during a scheduled laparoscopic liver procedure.
- Trial name
- NCT01237990
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Pathfinder Therapeutics
Liver Insufficiency
A Study of MK0431 in Patients WIth Hepatic Insufficiency (0431-017)(COMPLETED)
A study to compare the plasma concentrations of MK0431 at different times in patients with hepatic insufficiency vs healthy control subjects.
- Trial name
- NCT00696826
- Testing
- sitagliptin phosphate
- Volunteers
- 20 people
- Sponsor
- Merck Sharp & Dohme LLC
Hepatic Impairment
A Study to Evaluate the Pharmacokinetics (PK) and Safety of a Single Dose of Brensocatib in Participants With Normal Hepatic Function and Participants With Hepatic Impairment
The primary purpose of the study is to compare the PK of a single dose of brensocatib in participants with hepatic impairment to that in matched healthy control participants with normal hepatic function.
- Trial name
- NCT05517525
- Testing
- Brensocatib
- Where
- 3 sites in United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Insmed Incorporated
Hepatic Impairment
Pharmacokinetics of Leritrelvir(RAY1216) in Participants With Hepatic Impairment
This study will assess the effect of hepatic impairment on the pharmacokinetics (PK), safety and tolerability of Leritrelvir(RAY1216)
- Trial name
- NCT06161259
- Testing
- Leritrelvir(Ray1216)
- Where
- China
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Guangdong Raynovent Biotech Co., Ltd
Hepatic Impairment
A Study to Assess the Pharmacokinetics of Enasidenib (CC-90007) in Subjects With Moderate and Severe Hepatic Impairment.
This is a multi-center, open-label study to assess the PK of single 100 mg oral dose of enasidenib (CC-90007) in subjects with moderate and severe hepatic impairment, and in matched healthy control subjects with normal hepatic…
- Trial name
- NCT03290443
- Testing
- Enasidenib
- Where
- 5 sites in United States
- Volunteers
- 31 people
- Sponsor
- Celgene
Esophageal Cancer, Advanced Solid Tumor
Pharmacokinetics Study of Larotinib in Subjects With Impaired Hepatic Function
To evaluate the pharmacokinetics and safety of Larotinib in subjects with mild and moderate hepatic function impairment and healthy subjects in a single-center, non-randomized, open, single-dose administration
- Trial name
- NCT05048368
- Testing
- Larotinib
- Where
- China
- Volunteers
- healthy volunteers welcome
- Sponsor
- Sunshine Lake Pharma Co., Ltd.