Clinical trials: Moderate to Severe Functional Impairments
Schizophrenia, Renal Impairment
A Study of the Pharmacokinetics of ER OROS Paliperidone in Volunteers With Normal or Impaired Renal Function
The purpose of this study is to evaluate the pharmacokinetics of a single oral dose of 3 mg extended release paliperidone (ER OROSÃ' paliperidone) in patients with varying degrees of renal impairment (mild, moderate, and severe)…
- Trial name
- NCT00791401
- Testing
- ER OROS Paliperidone
- Volunteers
- 47 people, healthy volunteers welcome
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Normal Hepatic Function, Impaired Hepatic Function
Effect of Hepatic Impairment on LDE225..
This study is to evaluate the pharmacokinetics and safety of 800 mg of LDE225 in subjects with impaired hepatic function and healthy subjects with normal hepatic function.
- Trial name
- NCT01764776
- Testing
- LDE225
- Where
- 5 sites in United States, Belgium and 3 more
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Renal Impairment
A Pharmacokinetic Study of YM178 in Normal Subjects and Those With Mild, Moderate, and Severe Renal Impairment
The objective of this study is to assess and compare the pharmacokinetic properties of YM178 in normal subjects and those with mild, moderate and severe renal impairment.
- Trial name
- NCT00750620
- Testing
- YM178
- Where
- 2 sites in United States
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Inc
Healthy, Hepatic Insufficiency
A Study of the Pharmacokinetics and Safety of LY3537031 in Participants With Normal Liver Function and With Mild, Moderate, or Severe Liver Impairment
The purpose of this study is to measure how much LY3537031 gets into the bloodstream and how long it takes the body to eliminate it in participants with mild, moderate and severe impaired liver function and in healthy…
- Trial name
- NCT07165002
- Testing
- LY3537031
- Where
- 3 sites in Hungary, New Zealand and 1 more
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Hepatic Impairment
MEK162 in Healthy Subjects With Normal Hepatic Function and Subjects With Impaired Hepatic Function
This study is a phase I, multi-center, open-label, single oral dose, parallel group study to assess the PK and safety of MEK162 in subjects with impaired hepatic function and healthy subjects with normal hepatic function.
- Trial name
- MEK162 (NCT02050815)
- Testing
- MEK162
- Where
- 5 sites in United States
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- Array Biopharma, now a wholly owned subsidiary of Pfizer
Thrombosis
Evaluate Pharmacokinetics and Safety of BMS-986177 in Participants With Normal Renal Function and With Moderate or Severe Renal Impairment
Assess the pharmacokinetics, safety, and tolerability of a single dose of BMS-986177 in participants with normal renal function and moderate to severe renal impairment.
- Trial name
- NCT03196206
- Testing
- BMS-986177
- Where
- 3 sites in United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Renal Insufficiency
A Study to Test How Iclepertin is Taken up in the Blood of People With and Without Kidney Problems
This study is open to people with and without kidney problems. People can join the study if they are 18 years or older and have a body mass index (BMI) between 18.5 and 35 kg/m2.
- Trial name
- NCT05718843
- Testing
- BI 425809
- Where
- Germany
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Moderate Hepatic Impairment, Severe Hepatic Impairment
A Study to Learn About the Study Medicine (Called Lorlatinib) in People With Liver Dysfunction
The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called Lorlatinib) in health participants.
- Conditions
- Moderate Hepatic Impairment, Severe Hepatic Impairment, Healthy Volunteers
- Trial name
- NCT05224609
- Testing
- Lorlatinib
- Where
- 3 sites in United States
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- Pfizer
Renal Impairment, Healthy Volunteer
A Study to Evaluate the Pharmacokinetics of Entinostat in Adult Subjects With Normal and Impaired Renal Function
This purpose of this study is to evaluate the effects of a single dose of entinostat on subjects with varying levels of renal impairment.
- Trial name
- NCT03192111
- Testing
- Entinostat
- Where
- 3 sites in United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Syndax Pharmaceuticals
Chronic Hepatitis C
A Phase 1 Study to Evaluate the Pharmacokinetics of GS-5816 in Subjects With Normal Hepatic Function and Moderate or Severe Hepatic Impairment
This is a Phase 1 Open-Label, Parallel-Group, Single-Dose Study to evaluate the Pharmacokinetics of GS-5816 in subjects with normal hepatic function and moderate or severe hepatic impairment.
- Trial name
- NCT01817985
- Testing
- GS-5816
- Where
- 6 sites in United States, Puerto Rico
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- Gilead Sciences
Renal Impairment, Healthy Volunteers
A Study of ASP0367 in People With Kidneys That do Not Work Well and in Healthy People
This study is for adults whose kidneys do not work well (renal impairment) and adults whose kidneys work normally. This study will provide more information on a potential new treatment, called ASP0367.
- Trial name
- NCT05117294
- Testing
- Bocidelpar
- Where
- 4 sites in United States
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Global Development, Inc.
Renal Impairment, Normal Renal Function
PK Study in Subjects With Renal Impairment (Severe and if Required Mild & Moderate) Compared to Subjects With Normal Renal Function
This is an open-label, non randomised, single-dose, study in male and female subjects with renal impairment (severe and if required mild \& moderate) compared to male and female subjects with normal renal function.
- Trial name
- NCT04656795
- Testing
- MT-7117
- Where
- Germany
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Tanabe Pharma America, Inc.
Renal Impairment
Pharmacokinetics in Subjects With Renal Impairment
This is an open-label, non-randomized, parallel-group, mono-center, single intravenous dose, Phase I trial to investigate the Pharmacokinetic (PK) and safety of cilengitide in subjects with different grades of renal impairment as…
- Trial name
- NCT01504165
- Testing
- cilengitide 2000mg, cilengitide 1000mg, cilengitide > 1000mg and up to 2000mg
- Where
- 2 sites in Germany
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Merck KGaA, Darmstadt, Germany
Non-alcoholic Steatohepatitis, Hepatic Impairment
A Phase I Pharmacokinetic Study of TVB-2640 (Denifanstat) in Subjects With Mild, Moderate, or Severe Hepatic Impairment Compared to Subjects With Normal Hepatic Function
The goal of this phase 1 study is to assess the pharmacokinetics, safety and tolerability following multiple oral doses of TVB-2640 in subjects with mild, moderate, or severe hepatic impairment compared to healthy subjects with…
- Conditions
- Non-alcoholic Steatohepatitis, Hepatic Impairment, Cirrhosis
- Trial name
- NCT05835180
- Testing
- TVB-2640 - 50 mg
- Where
- 3 sites in United States, Hungary
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Sagimet Biosciences Inc.
Renal Impairment, Healthy Volunteer
A Study to Assess the Safety of Experimental Medication BMS986165 in Participants With Normal Kidney Function and Participants With Mild to End-Stage Kidney Disease.
The purpose of this study is to investigate BMS-986165 in participants with different levels of kidney function.
- Trial name
- NCT03890770
- Testing
- BMS-986165
- Where
- 6 sites in United States, Czechia and 2 more
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Renal Impairment
A Study to Evaluate Pharmacokinetic and Safety Trial of Emraclidine in Participants With Renal Impairment Compared With Participants With Normal Renal Function
The primary purpose of this study is to assess the effect of renal impairment on the pharmacokinetics (PK) of emraclidine following administration of a single oral dose in participants with mild, moderate, and severe renal…
- Trial name
- NCT05940402
- Testing
- Emraclidine
- Where
- 5 sites in United States
- Volunteers
- 58 people, healthy volunteers welcome
- Sponsor
- AbbVie
Renal Insufficiency, Healthy
A Study to Test How BI 1015550 is Taken up in the Blood of People With and Without Kidney Problems
This study is open to adults aged 18 years and older. People without kidney problems and people who have moderate or severe kidney problems can join the study.
- Trial name
- NCT05718648
- Testing
- BI 1015550
- Where
- Germany
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Participants With Moderate and Severe Renal Impairment and Healthy Participants
A Study to Investigate the Pharmacokinetics and Safety of PKN605 in Participants With Moderate and Severe Renal Impairment Compared to Matched Control Subjects With Normal Renal Function
The purpose of this trial is to assess any potential exposure increases of PKN605 in participants with reduced renal function to support decisions on participant eligibility and dosing in subsequent clinical trials of PKN605.
- Trial name
- NCT07797322
- Testing
- PKN605
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Hepatic Impairment
Pharmacokinetic (PK) and Safety Study of Iptacopan (LNP023) in Participants With Mild, Moderate, and Severe Hepatic Impairment Compared to Matched Control Healthy Participants With Normal Hepatic Function.
This was an open-label, single dose parallel group study to evaluate the PK of iptacopan in participants with mild, moderate, and severe hepatic impairment compared to matched healthy control participants.
- Trial name
- NCT05078580
- Testing
- Iptacopan
- Where
- United States
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Healthy, Renal Impairment
A Study to Test How BI 456906 is Taken up in the Blood of People With and Without Kidney Problems
This study is open to adults aged between 18 and 80 years of age with a body mass index (BMI) of 20 to 40 kg/m2. People with or without kidney problems can take part in the study.
- Trial name
- NCT06352411
- Testing
- BI 456906
- Where
- 2 sites in Germany
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim