Clinical trials: Severe Functional Impairment
Hepatic Insufficiency, Neoplasms
A Study to Evaluate CC-486/Onureg in Participants With Moderate or Severe Hepatic Impairment Compared With Normal Hepatic Function in Participants With Myeloid Malignancies
The purpose of this study is to evaluate the effect of moderate or severe liver impairment on the drug levels of oral azacitidine and the safety and tolerability of oral azacitidine in participants with myeloid malignancies.
- Trial name
- NCT05209295
- Testing
- Onureg
- Where
- 18 sites in United States, Argentina and 3 more
- Volunteers
- 2 people
- Sponsor
- Bristol-Myers Squibb
Hepatitis B
A Study to Evaluate Blood Levels of Bepirovirsen in Adult Participants With Severe or Moderate Kidney Disease
This is a 2-part study where all participants will receive bepirovirsen. The study will measure how much bepirovirsen from a single dose gets into the blood, and how long it stays in the blood.
- Trial name
- B-Kind (NCT07168356)
- Testing
- Bepirovirsen
- Where
- 3 sites in United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Severe Hepatic Impairment, Normal Hepatic Function
A Study to Investigate the Effect of Severely Diminished Liver Function on the Metabolism, Safety, and Tolerability of a Single Oral Dose of Enzalutamide in Men
The influence of severely diminished liver function on the metabolism, safety, and tolerability of a single oral dose of enzalutamide in a group of 8 men.
- Trial name
- NCT02138162
- Testing
- enzalutamide
- Where
- Bulgaria
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Europe B.V.
Renal Impairment
Pharmacokinetics (PK) and Safety of a Single Intravenous (IV) Dose of MK-3866 in Participants With Impaired Renal Function and in Healthy Controls (MK-3866-005)
The purpose of this study is to compare plasma and urine PK parameters of MK-3866 between participants with impaired renal function and healthy control participants, to investigate the extent to which MK-3866 is removed from the…
- Trial name
- NCT03259087
- Testing
- MK-3866
- Where
- 2 sites in United States
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Multiple Myeloma, Advanced Solid Tumors
Pharmacokinetics Study of Oral Ixazomib (MLN9708) in Relapsed/Refractory Multiple Myeloma and Advanced Solid Tumors Participants With Normal Renal Function or Severe Renal Impairment
The purpose of this study is to characterize the single-dose pharmacokinetic (PK) parameters of ixazomib (MLN9708) in cancer participants with either normal renal function or severe renal impairment (RI), including participants…
- Trial name
- NCT01830816
- Testing
- Ixazomib
- Where
- 11 sites in United States, Canada
- Volunteers
- 41 people
- Sponsor
- Millennium Pharmaceuticals, Inc.
Pharmacokinetics, Renal Impaired
Multiple Dose Pharmacokinetics of LCZ696 and Its Metabolites in Subjects With Severe Renal Impairment vs. Matched Healthy Subjects With Normal Renal Function
An open label, parallel-group study to determine multiple dose pharmacokinetics of LCZ696 and its metabolites in subjects with severe renal impairment compared to matched healthy subjects with normal renal function
- Conditions
- Pharmacokinetics, Renal Impaired, Healthy Volunteer
- Trial name
- NCT01569828
- Testing
- LCZ696A
- Where
- 3 sites in Germany, Russia and 1 more
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Renal Insufficiency, Healthy
Study of the Way the Body Takes up, Distributes, and Gets Rid of ACT-541468 in Subjects With Abnormal Kidney Function Compared to Healthy Subjects
Study of the way the body takes up, distributes, and gets rid of ACT-541468 in subjects with abnormal kidney function compared to healthy subjects
- Trial name
- NCT04024332
- Testing
- ACT-541468
- Where
- Germany
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Idorsia Pharmaceuticals Ltd.
Diabetes, Diabetes Mellitus, Type 2
Pharmacokinetics, Safety and Tolerability of Oral Semaglutide in Subjects With Hepatic Impairment
This trial is conducted in Europe. The aim of the trial is to investigate the pharmacokinetics (the exposure of the trial drug in the body), safety and tolerability of oral semaglutide (NNC0113-0217) in subjects with mild…
- Conditions
- Diabetes, Diabetes Mellitus, Type 2, Healthy
- Trial name
- NCT02016911
- Testing
- semaglutide
- Where
- 6 sites in Czechia, Poland and 1 more
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Novo Nordisk A/S
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
Known or Suspected Focal Liver Lesions, Severe Renal Impairment
Safety and Diagnostic Efficacy of Mangoral in Participants With Focal Liver Lesions and Reduced Kidney Function
The overall objective of this study is to evaluate the safety and diagnostic efficacy of Mangoral in liver MRI in participants with known or suspected focal liver lesions and severe renal impairment.
- Trial name
- SPARKLE (NCT04119843)
- Testing
- Mangoral
- Where
- 60 sites in United States, Argentina and 8 more
- Volunteers
- 87 people
- Sponsor
- Ascelia Pharma AB
Breast Cancer
A Study to Learn About the Relationship Between Hepatic Impairment and Myelosuppression (Decreased Bone Marrow Function) in Breast Cancer Patients Treated With the Study Medicine Palbociclib (Pal-bow-sai-klib)
The purpose of this study is to evaluate incidence of grade 4 neutropenia in patients who have hepatic impairment and use the study medicine Palbociclib.This study is seeking participants: - treated with the study medicine…
- Trial name
- NCT05912933
- Where
- United States
- Volunteers
- 1,342 people
- Sponsor
- Pfizer
Liver Dysfunction, Healthy
A Study of Lepodisiran (LY3819469) in Participants With Normal, Mild, Moderate, or Severe Liver Function
The main purpose of this study is to evaluate how much lepodisiran gets into the blood stream and how long it takes the body to get rid of it when given as a subcutaneous (SC) injection under the skin to participants with mild…
- Trial name
- NCT06916078
- Testing
- Lepodisiran
- Where
- 4 sites in United States, Hungary
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Study of Lutetium (177Lu) Vipivotide Tetraxetan in mCRPC Participants With Moderately and Severely Impaired and With Normal Renal Function
This study will address health authorities' requests to determine whether moderate and severe renal impairment have an impact on the biodistribution, dosimetry and safety of lutetium (177Lu) vipivotide tetraxetan (AAA617)…
- Trial name
- NCT06004661
- Testing
- AAA617, 68Ga-PSMA-11
- Where
- 9 sites in United States, France and 3 more
- Volunteers
- 23 people
- Sponsor
- Novartis Pharmaceuticals
Kidney Dysfunction
Pharmacokinetics Study of Nemonoxacin Malate Capsules in Subjects With Severe Impaired Renal Function
This is a single center, open-label, non-randomized, 1:1 parallel control and single dose administration study design. Healthy subjects will be matched to severe renal function impaired (eGFR≤30mL/min/1.73m2，CKD-EPI estimated)…
- Trial name
- NCT02840812
- Testing
- Nemonoxacin
- Where
- China
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Zhejiang Medicine Co., Ltd.
Renal Insufficiency
Pharmacokinetic Evaluation of Tirofiban Using a Single High-Dose Bolus In Subjects With Varying Degrees of Renal Function
The purpose of this study is to evaluate tirofiban concentration in the blood over a period of 24 hours after tirofiban administration. Subjects with varying degrees of renal insufficiency (i.e.
- Trial name
- NCT01766154
- Testing
- Tirofiban
- Where
- United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Medicure
Obesity
Study Examining The Effect Of Renal Impairment On Safety, Toleration And How The Body Processes An Experimental Drug
CP-945,598 is eliminated following extensive metabolism. For some drugs, decreased renal (kidney) function can affect their elimination from the body via metabolism.
- Trial name
- NCT00472836
- Testing
- CP-945,598
- Where
- 2 sites in United States
- Volunteers
- 17 people, healthy volunteers welcome
- Sponsor
- Pfizer
Hepatic Cirrhosis, Alcoholism
Pharmacokinetics and Safety of Single Subcutaneous Pasireotide (SOM230) in Subjects With Varying Degrees of Hepatic Function
The purpose of this study is to evaluate the effect of varying degrees of hepatic function (Child-Pugh classification) on the pharmacokinetics and safety of pasireotide s.c. in subjects.
- Trial name
- NCT00698464
- Testing
- Pasireotide
- Where
- 4 sites in United States, Belgium and 2 more
- Volunteers
- 34 people
- Sponsor
- Novartis Pharmaceuticals