Clinical trials: Hepatic Function
Hepatic Impairment
Study to Evaluate a Dose of Telotristat Etiprate in Male and Female With Mild, Moderate and Severe Hepatic Insufficiency and Matched Healthy Subjects
The purpose of the protocol is to assess the pharmacokinetics, safety and tolerability of a single dose of telotristat etiprate in subjects with various stages of hepatic impairment compared to healthy control subjects.
- Trial name
- NCT02683577
- Testing
- telotristat etiprate
- Where
- 2 sites in Moldova, Romania
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Ipsen
Hepatic Insufficiency, Healthy
A Study of Imlunestrant (LY3484356) in Female Participants With Impaired Liver Function
The main purpose of this study is to measure how much of Imlunestrant (LY3484356) gets into the bloodstream and how long it takes the body to eliminate it in female participants with impaired liver function compared to female…
- Trial name
- NCT05440344
- Testing
- Imlunestrant
- Where
- 3 sites in United States
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Healthy Study Participants, Impaired Hepatic Function
A Pharmacokinetic Study of Padsevonil in Study Participants With Either Normal or Moderately Impaired Hepatic Function
The purpose of the study is to evaluate the plasma pharmacokinetic (PK), safety and tolerability of padsevonil (PSL) in hepatically impaired and non-hepatically impaired study participants.
- Trial name
- NCT04136444
- Testing
- Padsevonil
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- UCB Biopharma S.P.R.L.
Hepatic Impairment, Healthy
Pharmacokinetics Study of MCI-186 in Subjects With Mild or Moderate Hepatic Impairment
To assess the pharmacokinetics of MCI-186 after a single intravenous infusion of 30mg/hour in subjects with mild or moderate Hepatic impairment compared to subjects with normal hepatic function
- Trial name
- NCT03289234
- Testing
- MCI-186
- Where
- 2 sites in Japan
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Shionogi
Hepatic Impairment, Healthy Volunteers
A Study of Soticlestat in Adults With Liver Failure Compared to Those With Normal Liver Function
The main aim is to check the effect of a single dose of soticlestat in adults with moderate or mild liver failure compared to healthy adults with normal liver function. Participants will check into the study clinic for 8 days.
- Trial name
- NCT05098054
- Testing
- Soticlestat
- Where
- 6 sites in United States, Hungary
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Takeda
Severe Hepatic Impairment
Evaluate Severe Hepatic Impairment on Dacomitinib PK
This is a post approval requirement to study the effect of severe hepatic impairment on the pharmacokinetics of dacomitinib.
- Trial name
- NCT03865446
- Testing
- Dacomitinib
- Where
- 3 sites in United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Pfizer
Carcinoma, Hepatocellular
c-Met Second-Line Hepatocellular Carcinoma
This is a Phase 1b/2, multicenter, single arm trial to assess the efficacy, safety, and pharmacokinetics (PK) of MSC2156119J as monotherapy in subjects with MET+ advanced hepatocellular carcinoma (HCC) with child Pugh Class A…
- Trial name
- NCT02115373
- Testing
- Tepotinib
- Where
- Germany
- Volunteers
- 66 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
Type 2 Diabetes Mellitus, Hepatic Impairment
Pharmacokinetics, Safety, and Tolerability of Ertugliflozin (MK-8835/PF-04971729) in Participants With Hepatic Impairment and in Healthy Participants (MK-8835-014)
This is a study to assess the pharmacokinetics and safety of ertugliflozin (MK-8835, PF-04971729) in participants with hepatic impairment versus healthy participants.
- Trial name
- NCT02115347
- Testing
- Ertugliflozin 15 mg
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Moderate Hepatic Impairment, Normal Hepatic Function
A Study to Evaluate the Effect of IV Doses of Rivipansel in Subjects With Moderate Hepatic Impairment and in Healthy Subjects With Normal Hepatic Function
The purpose of this study is to determine the effect of hepatic impairment on rivipansel PK and safety.
- Trial name
- NCT02871570
- Testing
- Rivipansel
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- GlycoMimetics Incorporated
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
Depressive Disorder, Major
A Study of LY2216684 in Participants With Impaired Hepatic Function
The purpose of this study is to evaluate the effect of liver function on how much of the study drug (LY2216684) gets into the blood stream and how long it takes the body to get rid of it.
- Trial name
- NCT01241435
- Testing
- LY2216684
- Where
- 3 sites in United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Cancer
A Study of Vismodegib in Patients With Advanced Solid Malignancies Including Hepatocellular Carcinoma With Varying Degrees of Renal or Hepatic Function
This is a Phase Ib, open-label, multiple-center, multiple-dose study designed to evaluate the pharmacokinetics and safety of vismodegib in patients with advanced solid malignancies (including hepatocellular carcinoma and…
- Trial name
- NCT01546519
- Testing
- Vismodegib
- Where
- 5 sites in United States
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- Genentech, Inc.
Nonalcoholic Steatohepatitis (NASH), Primary Sclerosing Cholangitis (PSC)
Pharmacokinetics and Pharmacodynamics of Cilofexor in Adults With Normal and Impaired Hepatic Function
The primary objective of this study is to evaluate the single-dose pharmacokinetics of cilofexor in adults with impaired hepatic function relative to matched, healthy controls with normal hepatic function.
- Trial name
- NCT02808312
- Testing
- Cilofexor
- Where
- 5 sites in United States, New Zealand
- Volunteers
- 57 people, healthy volunteers welcome
- Sponsor
- Gilead Sciences
Healthy, Hepatic Insufficiency
Study of Pirtobrutinib (LOXO-305) in Participants With Impaired Liver Function and Healthy Participants
The main purpose of this study is to measure how much of pirtobrutinib (LOXO-305) gets into the bloodstream and how long it takes the body to eliminate it in participants with impaired liver function and healthy participants.
- Trial name
- NCT06190691
- Testing
- Pirtobrutinib
- Where
- 8 sites in United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Schizophrenia
A Study Evaluating the of OPC-34712 in Subjects With Normal Hepatic Function and Hepatically Impaired Subjects
The purpose of this study is to evaluate how much of the investigational product gets into the blood stream and how long the body takes to get rid of it when given to subjects with a range of liver impairment compared to subjects…
- Trial name
- NCT01299454
- Testing
- OPC-34712
- Where
- 3 sites in United States
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Severe Hepatic Impairment
Pharmacokinetics, Safety and Tolerability of Vortioxetine in Normal Hepatic Function or Severe Hepatic Impairment
The purpose of this study is to evaluate the pharmacokinetics of vortioxetine and its metabolites Lu AA34443 and Lu AA39835 following a single oral dose administration of vortioxetine 5 mg in participants with severe hepatic…
- Trial name
- NCT02170220
- Testing
- Vortioxetine
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Takeda
Acute Liver Failure, Fulminant Hepatic Failure
Safety and Efficacy of the ELAD System (ELAD) to Treat Acute Liver Failure (ALF)
This phase 2 study is developed to evaluate the effect of ELAD on overall survival (OS) in subjects with acute liver failure (ALF) compared to matched historical controls.
- Conditions
- Acute Liver Failure, Fulminant Hepatic Failure, Primary Graft Non-Function, Surgically-Induced Liver Failure
- Trial name
- NCT01875874
- Testing
- ELAD
- Where
- 18 sites in United States
- Volunteers
- 8 people
- Sponsor
- Vital Therapies, Inc.
Hepatic Impairment, Healthy Volunteers
A Study to Evaluate Pharmacokinetics (PK) and Safety of Oral Mobocertinib in Participants With Moderate or Severe Hepatic Impairment (HI) and Normal Hepatic Function
The purpose of this study is to characterize the single-dose plasma PK of mobocertinib and its active metabolites (AP32960 and AP32914) in participants with moderate and/or severe HI compared to matched-healthy participants with…
- Trial name
- NCT04056468
- Testing
- Mobocertinib
- Where
- 2 sites in United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Millennium Pharmaceuticals, Inc.
Carcinoma, Hepatocellular
Efficacy, Safety, and Pharmacokinetic of MSC2156119J in Asian Participants With Hepatocellular Carcinoma
This is an open-label, integrated, Phase 1b/2 trial to determine the recommended Phase 2 dose (RP2D) and to evaluate the efficacy, safety, and pharmacokinetic of MSC2156119J as first-line treatment versus sorafenib in subjects…
- Trial name
- NCT01988493
- Testing
- Tepotinib 300 mg, Tepotinib 500 mg, Tepotinib 1000 mg
- Where
- 43 sites in China, South Korea and 1 more
- Volunteers
- 117 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
Hepatic Impairment
An Open-label, Non-randomized, Parallel Group Study in Subjects With Mild and Moderate Hepatic Insufficiency and Healthy Volunteers
Multi-center, non-randomized, open-label, single-dose, parallel group study to determine the effect of impaired hepatic function on the PK of deferiprone and its 3-O-glucuronide metabolite following a single oral dose of 33mg/kg…
- Trial name
- NCT01767103
- Testing
- Ferriprox®
- Where
- 2 sites in United States
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- ApoPharma