Clinical trials: Moderate Hepatic Impairment
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
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
Pharmacokinetics of Sotorasib in Healthy Participants and Participants With Moderate or Severe Hepatic Impairment
The main purpose of the study is to evaluate the pharmacokinetics (PK) of a single oral dose of sotorasib administered in participants with moderate or severe hepatic impairment compared to participants with normal hepatic…
- Trial name
- NCT04887064
- Testing
- Sotorasib
- Where
- 5 sites in United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Amgen
Hepatic Insufficiency
Assessment of Pharmacokinetics of Single Dose Odanacatib (MK-0822) in Participants With Moderate Hepatic Insufficiency (MK-0822-070)
This open-label, non-randomized study was designed to compare pharmacokinetics of a single 50 milligram (mg) dose of MK-0822 in participants with and without moderate hepatic insufficiency (abnormal liver function) in order to…
- Trial name
- NCT01512693
- Testing
- MK-0822
- Volunteers
- 17 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Solid Tumors
To Assess the Pharmacokinetics, Safety and Tolerability of Selumetinib in Patients With Hepatic Impairment and Healthy Subjects
A study to assess the pharmacokinetics, safety and tolerability of Selumetinib (AZD6244, ARRY-142886) in patients with hepatic impairment and healthy subjects.
- Trial name
- NCT02063230
- Testing
- Selumetinib 50mg, Selumetinib 25mg
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Hepatic Impairment
Study to Estimate the Effects of Hepatic Impairment on the Pharmacokinetics (PK) of PF-07321332
The study is to estimate the effect of hepatic impairment on the plasma PK of PF-07321332/ritonavir. Findings from this study will be used to develop dosing recommendations so that the dose and/or dosing interval may be adjusted…
- Trial name
- NCT05005312
- Testing
- PF-07321332, Ritonavir
- Where
- 2 sites in United States
- Volunteers
- 17 people, healthy volunteers welcome
- Sponsor
- Pfizer
COVID-19
A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of ALG-097558 in Subjects With Hepatic Impairment and in Healthy Subjects With Normal Hepatic Function
This is a Phase 1 non-randomized, open-label, multiple dose, parallel-group study of ALG-097558 in subjects with moderate hepatic impairment and subjects without hepatic impairment, matched for age, body weight and, to the extent…
- Trial name
- NCT06568861
- Testing
- ALG-097558
- Where
- 2 sites in United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Aligos Therapeutics
Healthy, Hepatic Insufficiency
A Study of LY3502970 in Participants With Impaired and Normal Liver Function
The main purpose of this study is to measure how much of LY3502970 gets into the bloodstream and how long it takes the body to eliminate it in participants with mild, moderate and severe impaired liver function compared to…
- Trial name
- NCT05882032
- Testing
- LY3502970
- Where
- 4 sites in United States
- Volunteers
- 29 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
HCV Infection
Pharmacokinetics of Voxilaprevir in Adults With Normal Hepatic Function and Moderate or Severe Hepatic Impairment
The primary objective of this study is to evaluate the pharmacokinetics (PK), safety, and tolerability of a single dose of voxilaprevir (formerly GS-9857) in participants with normal hepatic function, moderate hepatic impairment…
- Trial name
- NCT02397707
- Testing
- Voxilaprevir
- Where
- 4 sites in United States, Germany and 1 more
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- Gilead Sciences
Human Immunodeficiency Virus (HIV) Infection
Single-Dose Islatravir in Moderate Hepatic Impairment (MK-8591-030)
This is an open-label, single-dose study of the plasma pharmacokinetics (PK), safety, and tolerability of islatravir (ISL, MK-8591), and the intracellular PK of ISL triphosphate (ISL-TP) in male and female adult participants with…
- Trial name
- NCT04515641
- Testing
- Islatravir
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Chronic Hepatic Impairment
A Study to Assess Pharmacokinetics of Preladenant in Participants With Chronic Hepatic Impairment (P06513)
The purpose of this study is to compare the pharmacokinetics (PK) of preladenant after administration of a single 5 mg oral dose of preladenant in participants with hepatic impairment and healthy volunteers.
- Trial name
- NCT01465412
- Testing
- Preladenant
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
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
Liver Diseases, Healthy
Influence of Mild and Moderate Hepatic Impairment on the Pharmacokinetics, Safety and Tolerability of Various Doses of Afatinib
Up to 38 subjects entered with the aim of entering 8 subjects with mild liver impairment (at highest dose of afatinib), 8 subjects with moderate liver impairment (at either highest dose or two lower doses) and 8 healthy matched…
- Trial name
- NCT01298063
- Testing
- Afatinib
- Where
- Germany
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Moderate Hepatic Impairment
A Study of Belzutifan (MK-6482) in Participants With Hepatic Impairment (MK-6482-020)
The primary purpose of this study is to compare the plasma pharmacokinetics (PK) of belzutifan (MK-6482) following a single oral 80 mg dose of belzutifan in participants with moderate hepatic impairment to that of healthy matched…
- Trial name
- NCT04995484
- Testing
- Belzutifan
- Where
- 2 sites in United States
- Volunteers
- 17 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Healthy Volunteer
A Study of The Effect of Hepatic Impairment on The Pharmacokinetics of Aleglitazar
This open-label study will assess the effects of hepatic impairment on the pharmacokinetics of a single oral dose of aleglitazar in subjects with mild or moderate hepatic impairment (Child-Pugh class A or B) and in matched…
- Trial name
- NCT01197911
- Testing
- aleglitazar
- Where
- 2 sites in United States
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Muscular Atrophy, Spinal
A Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics and Safety and Tolerability of a Single Oral Dose of Risdiplam Compared to Matched Healthy Participants With Normal Hepatic Function
This is a multi-center, open-label, non-randomized, parallel-group, 2-part study to evaluate the effect of hepatic impairment on the PK and safety and tolerability of a single oral dose of risdiplam compared to matched healthy…
- Trial name
- NCT03920865
- Testing
- Risdiplam
- Where
- 3 sites in United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Hepatic Insufficiency, Antibacterial Agents
Single-Dose Pharmacokinetics of MK-3866 in Participants With Hepatic Impairment (MK-3866-006)
This is an open-label, single-dose, Phase 1 study to evaluate the pharmacokinetics (PK) of intravenous (IV) MK-3866 in participants with moderate and severe hepatic impairment (HI) compared to that of matched healthy…
- Trial name
- NCT03295266
- Testing
- MK-3866
- Where
- 2 sites in United States
- Volunteers
- 9 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Epilepsy
An Open-label, Multiple-dose, Single-centre Study, Investigating the Pharmacokinetics of BIA 2-093
Open-label, multiple-dose, single-centre study in 2 groups of subjects: subjects with moderate hepatic impairment and healthy controls. The trial consisted of a screening visit, a treatment phase and a follow-up visit.
- Trial name
- NCT02281526
- Testing
- BIA 2-093
- Where
- South Africa
- Volunteers
- 17 people, healthy volunteers welcome
- Sponsor
- Bial - Portela C S.A.
Hepatic Impairment
Study to Evaluate the Pharmacokinetics of Lemborexant (E2006) and Its Metabolites in Subjects With Mild and Moderate Hepatic Impairment Compared to Healthy Subjects
This study will be conducted to assess the effect of mild and moderate hepatic impairment on the pharmacokinetics (PK) of lemborexant after a single-dose administration.
- Trial name
- NCT03440424
- Testing
- Lemborexant
- Where
- 2 sites in United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
Tuberculosis
Pretomanid in Adults With Hepatic Impairment
This is a Phase 1, single dose (200 mg), open-label study comparing the pharmacokinetics and safety of Pretomanid in subjects with mild, moderate, and severe hepatic impairment to matched, non-hepatically impaired subjects.
- Trial name
- NCT02422524
- Testing
- PA-824
- Where
- 2 sites in United States
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)