Clinical trials: Functional Impairment
Hepatic Impairment, Healthy, Hepatic Insufficiency
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.
- Conditions
- Hepatic Impairment, Healthy, Hepatic Insufficiency, Healthy Adults
- Trial name
- NCT07677358
- Testing
- Atirmociclib
- Where
- 3 sites in United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Pfizer
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
Renal Impairment
Assessment of the Pharmacokinetics and Safety of ANT3310 Combined With Meropenem in Renally Impaired Subjects
This is an open-label, non-randomized, single-center, single i.v. dose Phase 1 trial to evaluate the pharmacokinetics and safety of a combination of ANT3310 and meropenem in participants with different degrees of renal function…
- Trial name
- NCT06527677
- Testing
- ANT3310, Meropenem
- Where
- Germany
- Volunteers
- 41 people, healthy volunteers welcome
- Sponsor
- Antabio
Cardiac Failure, Myocardial Failure
An Investigational Study of Continuous 8-Hour Intravenous Administrations of BMS-986231 in Participants With Heart Failure and Reduced Heart Function Given a Standard Dose of Loop Diuretic
The purpose of this study is to investigate continuous 8-hour introductions of BMS-986231 in participants with heart failure and weakened heart function given a standard dose of diuretic.
- Conditions
- Cardiac Failure, Myocardial Failure, Congestive Heart Failure, Heart Decompensation
- Trial name
- NCT03730961
- Testing
- BMS-986231, Furosemide
- Where
- 2 sites in United Kingdom
- Volunteers
- 23 people
- Sponsor
- Bristol-Myers Squibb
Hepatic Impairment
To Evaluate the Pharmacokinetics (PK) and Safety of Tavapadon in Participants With Mild and Moderate Hepatic Impairment Compared to Participants With Normal Hepatic Function
The primary purpose of the study is to assess the effect of hepatic impairment on the PK of tavapadon following administration of a single oral dose in participants with mild and moderate hepatic impairment relative to age, body…
- Trial name
- NCT05404529
- Testing
- Tavapadon
- Where
- 3 sites in United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Cerevel Therapeutics, LLC
Glomerulonephritis
Study of HRS-5965 in Healthy Subjects and Subjects With Renal Insufficiency
The trial is the first human trial. The safety, tolerability, PK and PD of HRS-5965 tablets will be evaluated in healthy subjects and subjects with impaired renal function.
- Trial name
- NCT05505955
- Testing
- HRS-5965
- Where
- China
- Volunteers
- 83 people, healthy volunteers welcome
- Sponsor
- Chengdu Suncadia Medicine Co., Ltd.
Acute Myocardial Infarction
A Study of CSL112 in Healthy Adults and in Adults With Moderate Renal Impairment
This is a phase 1 multicenter, randomized, double-blind, placebo-controlled, ascending dose study to investigate the pharmacokinetics (PK), safety, and tolerability of CSL112 in adult subjects with moderate renal impairment and…
- Trial name
- NCT02427035
- Testing
- CSL112
- Where
- 4 sites in Germany, United Kingdom
- Volunteers
- 32 people
- Sponsor
- CSL Behring
Hepatic Impairment
A Study to Evaluate the Pharmacokinetics and Safety of DBPR108 in Subjects With Hepatic Impairment
This is an open-label, single-dose study to evaluate the pharmacokinetics and safety of DBPR108 in subjects with mild or moderate hepatic impairment (HI) compared to the matched control subjects with normal hepatic function.
- Trial name
- NCT04859426
- Testing
- DBPR108 tablets
- Where
- China
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Renal Impairment, Renal Insufficiency
Elafibranor Pharmacokinetic Parameters in Renal Impaired Patients
This study is being conducted in order to assess the need for dose adjustment for elafibranor in participants with renal impairment.
- Conditions
- Renal Impairment, Renal Insufficiency, Kidney Diseases, Pharmacokinetics
- Trial name
- NCT03844555
- Testing
- Elafibranor
- Where
- 2 sites in France, Romania
- Volunteers
- 23 people, healthy volunteers welcome
- Sponsor
- Genfit
Healthy Volunteers, Patients
To Compare the Pharmacokinetics of a Single Oral Dose of TC-5214 in Subjects With Renal Impairment and With Subjects With Normal Renal Function
The purpose of this study is to compare the absorption and distribution of a single oral dose of TC-5214 in subjects with renal impairment and with subjects with normal renal function.
- Conditions
- Healthy Volunteers, Patients, Pharmacokinetics, Renal Impairment
- Trial name
- NCT01240967
- Testing
- TC-5214
- Where
- 2 sites in United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Hepatic Impairment
Safety and Pharmacokinetics of CMX001 in Impaired Hepatic Function and Healthy Subjects
This is an open-label, non-randomized, multi-center, sequential group, safety, tolerance, and Pharmacokinetic study of a single dose of CMX001 administered at 2 mg/kg of ideal body weight rounded to the closest 20 mg in fasted…
- Trial name
- NCT05391724
- Testing
- CMX001
- Where
- 3 sites in United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Jazz Pharmaceuticals
Graft Rejection, Kidney Failure
Study Of The Safety And Efficacy Of Conversion From A CNI To Sirolimus In Renally-Impaired Heart Transplant Recipients
The primary purpose of this study is to determine whether converting from calcineurin inhibitor (CNI) therapy to sirolimus therapy will be more effective than continuing calcineurin inhibitor therapy with respect to renal…
- Trial name
- NCT00369382
- Testing
- cyclosporine or tacrolimus, sirolimus
- Where
- 23 sites in United States, Australia and 5 more
- Volunteers
- 121 people
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Hepatic Impairment, NASH - Nonalcoholic Steatohepatitis
Phase 1 Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Multiple Oral Doses of MGL-3196 in Subjects With Varying Degrees of Hepatic Impairment and Healthy Matched Control Subjects
The purpose of this study is to directly characterize the pharmacokinetic (PK) profiles of MGL-3196 and its major metabolite (MGL-3623) following administration of multiple oral doses (QD x 6 days) in subjects with varying…
- Conditions
- Hepatic Impairment, NASH - Nonalcoholic Steatohepatitis, Cirrhosis, Liver
- Trial name
- NCT04643795
- Testing
- MGL-3196
- Where
- 3 sites in United States
- Volunteers
- 87 people, healthy volunteers welcome
- Sponsor
- Madrigal Pharmaceuticals, Inc.
Gram-negative Bacterial Infections
Pharmacokinetics and Safety of HRS-8427 in Healthy Volunteers and in Patients With Impaired Renal Function
This study evaluated the pharmacokinetic profile, safety, and tolerability of HRS-8427 injection in subjects with mild, moderate, severe, or end-stage renal disease (ESRD) requiring dialysis, using subjects with normal renal…
- Trial name
- NCT07070375
- Testing
- HRS-8427
- Where
- China
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Renal Impairment
An Open-label, Non-randomized, Parallel Group Study in Subjects With Mild, Moderate, Severe, or No Renal Impairment
Multi-center, non-randomized, open-label, single-dose, parallel group study to determine the effect of impaired renal function on the PK of deferiprone and its 3-O-glucuronide metabolite following a single oral dose of 33mg/kg…
- Trial name
- NCT01770652
- Testing
- Deferiprone
- Where
- 2 sites in Canada
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- ApoPharma
Diabetes Mellitus, Type 2
Pharmacokinetic, Safety/Tolerability Study of a Single SC Dose of PB1023 Injection in Subjects With Normal and Impaired Renal Function
Primary objective: To compare the pharmacokinetic profile of Glymera (PB1023) Injection after a single dose administered by subcutaneous injection to subjects with normal renal function and impaired renal function.
- Trial name
- NCT01478399
- Testing
- PB1023 Injection
- Where
- 2 sites in United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- PhaseBio Pharmaceuticals Inc.
Severe Hepatic Impairment, Healthy
PK Study in Subjects With Severe Hepatic Impairment
This is an open-label, single-dose study in male and female subjects with severe hepatic impairment and in male and female subjects with normal hepatic function.
- Trial name
- MCI-186-E05 HP (NCT03664544)
- Testing
- MCI-186
- Where
- 3 sites in Czechia, Hungary and 1 more
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Shionogi
Chronic Kidney Disease, Acute Kidney Injury
FAST GFR: Pilot Study to Evaluate the Safety of the FAST GFR Test in Patients.
This is a single site study designed to evaluate the FAST mGFR Test™ in healthy adult volunteers, patients with varying degrees of chronic kidney disease (CKD), and patients with acute kidney injury (AKI).
- Trial name
- NCT01978314
- Testing
- 75 mg / 6 mL VFI™
- Where
- United States
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- FAST BioMedical
Diabetes Mellitus, Type 2
To Compare the Safety and PK/PD Characteristics of Subjects With Between Hepatic Impairment and Normal Hepatic Function
This study aims to evaluate the pharmacokinetics, pharmacodynamics, safety, and tolerability of DWP16001 in subjects with hepatic impairment compared with subjects with normal hepatic function.
- Trial name
- NCT05747664
- Testing
- DWP16001
- Where
- South Korea
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Daewoong Pharmaceutical Co. LTD.
Healthy
BI 1744 CL in Patients With Severe Renal Impairment in Comparison to Subjects With Normal Renal Function
Study to assess the influence of severe renal impairment on the pharmacokinetics (PK), safety, and selected pharmacodynamic (PD) parameters of BI 1744 CL (30 μg administered by inhalation with the Respimat® Inhaler)
- Trial name
- NCT02172118
- Testing
- BI 1774 CL
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim