Hepatic Impairment

20

Review clinical trials related to Hepatic Impairment. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Not yet recruiting

A Study to Learn How the Study Medicine Called Atirmociclib is Handled by the Body in People With Normal Liver Function and Different Levels of Liver Disease

The purpose of this study to understand how the study medicine atirmociclib behaves in the body and how safe it is for people with different levels of liver health. The study is seeking participants who are: * Aged 18 years or older * Have a BMI of 17.5 to 40 kg/m2, and body weight more than 50 kg. * Have normal liver function or have stable mild, moderate, or severe liver disease Participants will receive study medicine by mouth. Blood samples will be collected to see how much of the medicine is in the body over time. This will help understand whether liver disease changes how the medicine is handled. Participants will be in the study for about 9 weeks. Those with normal liver function will stay in the clinic for about 7 days. People with liver disease will stay for about 9 days. After leaving the clinic, people may be contacted for follow-up. This may be done by phone or through a clinic visit.

Participants needed: 28
Trial details
Phase: Phase 1Age: 18+Biological sex: AllType: InterventionalSponsor: PfizerUpdated: Jun 30, 2026Locations: 3
Eligibility criteria

BMI of 17.5-40 kg/m2; and a total body weight >50 kg (110 lb). [+2]

Any condition or history of surgery possibly affecting drug absorption. [+1]

Status: Recruiting

Effect of Hepatic Impairment on the Pharmacokinetics of Mirdametinib

The purposes of this study are to determine: * The pharmacokinetics (the amount of study drug in your blood and how long it takes the body to get rid of it) of the study drug and its metabolites (substances produced as the body breaks down the study drug) in participants with moderate or severe liver function impairment compared to participants with normal liver function (also known as a healthy volunteer). Pharmacokinetics (or PK) is the study of how your body absorbs, breaks down, and removes a study drug. * How well the study drug is tolerated and any side effects that may occur in participants with moderate or severe liver function impairment compared to participants with normal liver function. This study is for research purposes only and is not intended to treat any medical condition.

Participants needed: 32
Trial details
Phase: Phase 1Age: 18-80Biological sex: AllType: InterventionalSponsor: SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, GermanyUpdated: Jun 22, 2026Locations: 3
Eligibility criteria

Participant understands the study procedures, is willing to comply with all stud... [+22]

Participant is deemed unsuitable for this study in the opinion of the Investigat... [+29]

Status: Recruiting

A Study to Assess the Drug Levels and Safety of BMS-986435 in Participants With Normal Hepatic Function and Participants With Different Degrees of Hepatic Impairment

The purpose of this study is to determine the pharmacokinetic and safety of BMS-986435 in participants with normal hepatic function and participants with different degrees of hepatic impairment

Participants needed: 24
Trial details
Phase: Phase 1Age: 18-75Biological sex: AllType: InterventionalSponsor: Bristol-Myers SquibbUpdated: Jun 12, 2026Locations: 3
Eligibility criteria

Participant must have documented LVEF ≥ 60% (2D biplane Simpson's Method) and ab... [+2]

Participants must not have history of or current uncontrolled or unstable clinic... [+4]

Status: Not yet recruiting

A Study to Evaluate the Pharmacokinetics (PK) and Safety of a Single Dose of Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Normal Hepatic Function and Participants With Hepatic Impairment

The primary purpose of the study is to determine the effect of mild, moderate, and severe hepatic impairment on the PK of total treprostinil palmitil (TP) and treprostinil (TRE) following a single dose of 80 micrograms (μg) TPIP, when compared to normal hepatic function.

Participants needed: 30
Trial details
Phase: Phase 1Age: 18-70Biological sex: AllType: InterventionalSponsor: Insmed IncorporatedUpdated: Jun 11, 2026
Eligibility criteria

Body mass index between 18.0 and 40.0 kilograms per square meter (kg/m²), inclus... [+4]

History of stomach or intestinal surgery or resection that would potentially alt... [+9]

Status: Recruiting

A Study to Test How BI 1291583 is Taken up in the Blood of People With and Without Liver Problems

This study is open to adults aged between 18 and 80 years of age with a body mass index (BMI) of 18.5 to 42 kg/m². People with or without liver problems can take part in the study. The purpose of this study is to find out how much of a medicine called BI 1291583 gets into the blood of people with and without liver problems. BI 1291583 is being developed to treat people with bronchiectasis, a chronic disease of the lungs. People living with this condition often also have liver problems. Therefore, it is important to find out whether liver problems influence the amount of BI 1291583 that gets into the blood. Study participants receive a single dose of BI 1291583 as a tablet taken by mouth. Participants are divided into 4 groups based on how well their liver works: 1 group without liver problems, and 3 groups with mild, moderate, and severe liver problems. Each participant without liver problems is matched with participants from the other groups based on factors such as age, sex, smoking habits, and body weight to ensure accurate comparisons. Participants are in the study for about 3 months. They stay for 3 days at the study site and also visit the study site up to 9 times. During these visits, the doctors collect information about participants' health. To assess the study endpoints, the doctors regularly take blood samples from the participants. The doctors regularly check participants' health and take note of any unwanted effects.

Participants needed: 32
Trial details
Phase: Phase 1Age: 18-80Biological sex: AllType: InterventionalSponsor: Boehringer IngelheimUpdated: Jun 9, 2026Locations: 3
Eligibility criteria

Male or female trial participants aged ≥18 and ≤80 years at screening [+13]

Any medical condition or finding in the medical examination that in the investig... [+8]

Status: Recruiting

A Study to Evaluate the Effect of Moderate or Severe Hepatic Impairment on the Pharmacokinetics (PK) of Inavolisib

This open-label study will evaluate the effect on the pharmacokinetics (PK), safety, and tolerability of a single oral dose of inavolisib in participants with moderate or severe hepatic impairment compared with demographically matched healthy participants with normal hepatic function.

Participants needed: 32
Trial details
Phase: Phase 1Age: 18-80Biological sex: AllType: InterventionalSponsor: Genentech, Inc.Updated: Jun 8, 2026Locations: 4
Eligibility criteria

Body Mass Index 18.0 to 40.0 kilogram per meter square (kg/m²), inclusive, and b... [+10]

History of Type 1 diabetes or Type 2 Diabetes that is insulin-dependent or requi... [+14]

Status: Recruiting

A Phase I Study to Investigate the Effect of Hepatic Impairment of AZD9550 and AZD6234

The purpose of this study is to examine the safety and tolerability of AZD6234 and AZD9550 in participants with hepatic impairment and participants with normal hepatic function.

Participants needed: 28
Trial details
Phase: Phase 1Age: 18-85Biological sex: AllType: InterventionalSponsor: AstraZenecaUpdated: Jun 3, 2026Locations: 4
Eligibility criteria

Age 18-85 years at consent. [+7]

Any clinically significant disease; Diabetes; [+30]

Status: Recruiting

A Study to Learn How the Body Processes the Study Medicine PF-07328948 in People With and Without Reduced Liver Function

The purpose of this study is to understand the effects of decreased liver function on the study medicine (PF-07328948). People with decreased liver function may process the study medicine differently from healthy people. Study is seeking participants who: * Are between 18 and 75 years of age. * Have a BMI (body mass index) of 17.5 to 40 kg/m2, inclusive, and a total body weight of more than or equal to 45 kilograms or 99 pounds. Participants will take the study medicine as a tablet once at the study clinic and then will stay onsite for about 6 days. During this time, the study team will check for the participant's treatment experience and take some blood samples to test the level of PF-07328948. This will help understand if certain level of decreased liver function could affect the study medicine being processed in the body.

Participants needed: 26
Trial details
Phase: Phase 1Age: 18-74Biological sex: AllType: InterventionalSponsor: PfizerUpdated: May 26, 2026Locations: 3
Eligibility criteria

Male or female of nonchildbearing potential, between the ages of 18 (inclusive)... [+6]

Any condition possibly affecting drug absorption [+21]

Status: Recruiting

A Study to Test How BI 3000202 is Taken up in the Blood of People With and Without Liver Problems

This study is open to healthy people and people with liver problems. Adults between 18 and 80 years can participate. The purpose of this study is to compare how a medicine called BI 3000202 is handled by the body in people with and without liver problems. All participants take 1 tablet of BI 3000202. Participants with liver problems may also continue their regular treatment for their liver condition. Participants are in the study for about 1 month. During this time, participants visit the study site about 11 times. Where possible, some of these visits may happen by phone. For some visits, participants stay at the study site overnight. Doctors regularly test the amount of BI 3000202 in the blood and check for any health problems.

Participants needed: 44
Trial details
Phase: Phase 1Age: 18-80Biological sex: AllType: InterventionalSponsor: Boehringer IngelheimUpdated: May 14, 2026Locations: 1
Eligibility criteria

Adult participants ≥18 years and ≤80 years of age at Visit 1. [+7]

Participation in another clinical trial within 30 days or 5 half-lives of the in... [+11]

Status: Recruiting

Radiprodil in Participants With Hepatic Impairment

This Phase 1, open-label study will evaluate the pharmacokinetics (PK), safety, and tolerability of a single oral dose of radiprodil in adults with varying degrees of hepatic impairment compared with healthy participants. Radiprodil is being developed as a potential treatment for GRIN-related neurodevelopmental disorders, tuberous sclerosis complex, and focal cortical dysplasia. Approximately 40 adults aged 18 to 75 years will be enrolled into five cohorts based on liver function (mild, moderate, or severe hepatic impairment) or healthy status. Participants will receive a single 15 mg oral dose of radiprodil and remain in the clinical research unit for intensive PK and safety monitoring through Day 6. The primary objective is to characterize the PK profile of radiprodil in participants with hepatic impairment compared with healthy participants. Safety and tolerability will also be assessed. Results from this study will help determine whether dose adjustments are needed in individuals with impaired liver function.

Participants needed: 40
Trial details
Phase: Phase 1Age: 18-75Biological sex: AllType: InterventionalSponsor: GRIN Therapeutics, Inc.Updated: May 8, 2026Locations: 2
Eligibility criteria

Male or female participants aged 18 to 75 years, inclusive, at Screening. [+6]

History or presence of clinically significant medical conditions that could inte... [+7]

Status: Recruiting

Study of Bemnifosbuvir/Ruzasvir as a Fixed-dose Combination in Subjects With Normal or Severely Impaired Renal or Hepatic Function

To Assess the Effect of Severe Hepatic or Renal Impairment on the Pharmacokinetics of Bemnifosbuvir/Ruzasvir After a Single Dose

Participants needed: 28
Trial details
Phase: Phase 1Age: 18-80Biological sex: AllType: InterventionalSponsor: Atea Pharmaceuticals, Inc.Updated: Apr 13, 2026Locations: 2
Eligibility criteria

Must agree to use two methods of birth control from Screening through 90 days af... [+9]

Pregnant or breastfeeding [+11]

Status: Recruiting

Assessment of Quizartinib Pharmacokinetic in Subjects With Severe Hepatic Impairment

This study will evaluate and compare the PK in subjects with severe HI to that of matched healthy control subjects with normal hepatic function.

Participants needed: 12
Trial details
Phase: Phase 1Age: 18-75Biological sex: AllType: InterventionalSponsor: Daiichi SankyoUpdated: Apr 1, 2026Locations: 3
Eligibility criteria

Voluntarily consents to participate in this study and provides written informed... [+8]

Status: Recruiting

A Study of Calderasib (MK-1084) in Participants With Hepatic Impairment and Healthy Volunteers (MK-1084-017)

The purpose of this study is to learn what happens to calderasib levels in a person's body over time. Researchers will measure what happens to calderasib levels in the body when it is given to participants with hepatic (liver) impairment and healthy participants. Researchers also want to learn about the safety of MK-1084 when it is given to people with hepatic impairment and if people with hepatic impairment can tolerate it.

Participants needed: 58
Trial details
Phase: Phase 1Age: 18-80Biological sex: AllType: InterventionalSponsor: Merck Sharp & Dohme LLCUpdated: Mar 5, 2026Locations: 3
Eligibility criteria

Has a body mass index (BMI) between 18.0 and 42.0 kg/m² [+2]

Has a history of gastrointestinal disease which may affect food and drug absorpt... [+16]

Status: Recruiting

Hepatic Impairment With Cirrhosis Due to Cholestatic Liver Disease

A Phase 1, Open-label Extension Groups Study in Subjects having Hepatic Impairment with Cirrhosis due to Cholestatic Liver Disease

Participants needed: 30
Trial details
Phase: Phase 1Age: 18-80Biological sex: AllType: InterventionalSponsor: Zydus Therapeutics Inc.Updated: Feb 17, 2026Locations: 1
Eligibility criteria

Ability to comprehend and willingness to sign a written ICF for the study. [+13]

Any significant, unstable medical condition or other instability that would prev... [+23]

Status: Recruiting

Study to Evaluate the Pharmacokinetics (PK) of E7090 (Herein Referred to as Tasurgratinib) and Its Metabolite in Participants With Mild and Moderate Hepatic Impairment Compared to Healthy Participants

The primary purpose of the study is to evaluate the effects of mild and moderate hepatic impairment on PK of tasurgratinib after a single dose administration.

Participants needed: 18
Trial details
Phase: Phase 1Age: 20-79Biological sex: AllType: InterventionalSponsor: Eisai Co., Ltd.Updated: Jan 23, 2026Locations: 8
Eligibility criteria

Body mass index (BMI) between 18 to 40 kilogram per square meter (kg/m²). [+2]

Following ocular disorders [+9]

Status: Recruiting

Pharmacokinetics (PK) and Safety of Zanzalintinib in Participants With Moderate Hepatic Impairment (HI)

The primary purpose of this study is to evaluate the plasma PK of zanzalintinib following a single dose in participants with moderate liver dysfunction compared to matched healthy participants with normal liver function.

Participants needed: 20
Trial details
Phase: Phase 1Age: 18-75Biological sex: AllType: InterventionalSponsor: ExelixisUpdated: Jun 22, 2025Locations: 2
Eligibility criteria

No clinically significant medical history (aside from the HI for participants in... [+6]

• History of any medical or surgical conditions that would potentially alter abs... [+6]

Status: Recruiting

Effect of Hepatic Impairment on the Pharmacokinetics and Safety of VIR-2218 and VIR-3434

In this study, a single dose of VIR-2218 up to 200 mg SC or VIR-3434 at 300 mg SC monotherapy or a combination of VIR-2218 and VIR-3434 will be administered to assess the pharmacokinetic (PK) exposure, safety, and tolerability of VIR-2218 and VIR-3434 in participants with cirrhosis and Hepatic Impairment, defined using the Child-Pugh-Turcotte (CPT) categorization.

Participants needed: 144
Trial details
Phase: Phase 1Age: 18-70Biological sex: AllType: InterventionalSponsor: Vir Biotechnology, Inc.Updated: Jun 13, 2025Locations: 5
Eligibility criteria

Must be ≥18 to ≤70 years of age at screening [+8]

Participants with unstable cardiac function or evidence of previous myocardial i... [+13]

Status: Recruiting

A Study of HDM1002 in Subjects With And Without Varying Degrees Of Hepatic Impairement

The current study is proposed to evaluate whether there is any clinically meaningful effect of hepatic impairment on the plasma Pharmacokinetic (PK) of HDM1002

Participants needed: 40
Trial details
Phase: Phase 1Age: 18-70Biological sex: AllType: InterventionalSponsor: Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.Updated: May 22, 2025Locations: 1
Eligibility criteria

Age and Sex: Chinese subjects aged 18-70 years (inclusive) at screening, regardl... [+1]

History or family history of medullary thyroid carcinoma, thyroid C-cell hyperpl... [+9]

Status: Recruiting

A Study of RAY1225 in Participants With Impaired Liver Function

The purpose of this study is to assess how fast RAY1225 gets into the blood stream and how long it takes the body to remove it in participants with impaired liver function compared to healthy participants.

Participants needed: 24
Trial details
Phase: Phase 1Age: 18-75Biological sex: AllType: InterventionalSponsor: Guangdong Raynovent Biotech Co., LtdUpdated: Mar 19, 2025Locations: 1
Eligibility criteria

Participant must be ≥ 18 to ≤ 75 years; [+6]

Participants with an allergic disposition (multiple drug and food allergies) or... [+9]

Status: Not yet recruiting

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 the dose of MDMA need to be adjusted in people with abnormal liver function? Researchers will compare people with abnormal liver function to people with normal liver function. Participants will receive a single dose of MDMA then undergo periodic vitals measurements. They will remain at the study site for two more days undergoing more vitals measurements and having subjective effects and adverse events measured.

Participants needed: 16
Trial details
Phase: Phase 1Age: 18-65Biological sex: AllType: InterventionalSponsor: Resilient PharmaceuticalsUpdated: Oct 30, 2024Locations: 1
Eligibility criteria

Participants with moderate hepatic impairment (class B according to Child- Pugh'... [+6]

Have a current psychiatric diagnosis. [+15]