Clinical trials: Normal Physiology
Renal Insufficiency
Study to Evaluate Pharmacokinetics of ITCA 650 in Subjects With Renal Impairment Compared to Normal Subjects
A Phase 1 study to evaluate the pharmacokinetics of ITCA 650 in subjects with mild and moderate renal impairment compared to the pharmacokinetics of subjects with normal renal function
- Trial name
- NCT02320045
- Testing
- ITCA 650 (Exenatide in osmotic mini pump)
- Where
- 4 sites in United States, Germany
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Intarcia Therapeutics
Hepatic Impairment, Healthy Volunteers
A Research Study Looking at How a Single Dose of the Medicine Cagrilintide Works in Participants With Reduced Liver Function and in Healthy Participants With Normal Liver Function and How Cagrilintide is Absorbed and Used by the Body
The study is divided into two parts - Part A and Part B. Cagrilintide in combination with semaglutide, is under development for weight management.
- Trial name
- NCT05564104
- Testing
- Cagrilintide
- Where
- 4 sites in Czechia, Germany and 1 more
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Novo Nordisk A/S
Obesity/Overweight
Study of Pharmacokinetics and Safety of GZR18 Injection in Subjects With Renal Impairment and Normal Renal Function
This study adopts a multicenter, single-dose, open-label, and parallel design, which is aimed at assessing the PK and safety profiles of GZR18 Injection in subjects with normal renal function and those with mild, moderate or…
- Trial name
- NCT07141030
- Testing
- GZR18 injection
- Where
- China
- Volunteers
- 32 people
- Sponsor
- Gan & Lee Pharmaceuticals.
Non-alcoholic Steatohepatitis (NASH)
A Research Study Looking Into Blood and Urine Levels of the Medicine NNC0194-0499 in the Body and How Well it is Tolerated in Participants With Reduced Kidney Function and Normal Kidney Function
Novo Nordisk is developing the study medicine NNC0194-0499 for the treatment of non-alcoholic steatohepatitis (NASH). NASH is a serious disease where fat, inflammation and scar tissue builds up in the liver.
- Trial name
- NCT05727644
- Testing
- NNC0194-0499
- Where
- Germany
- Volunteers
- 42 people
- Sponsor
- Novo Nordisk A/S
Renal Impairment, Healthy
Pharmacokinetics Study of MCI-186 in Subjects With Mild or Moderate Renal Impairment
To assess the pharmacokinetics of MCI-186 after a single intravenous infusion of 30mg/hour in subjects with mild or moderate renal impairment compared to subjects with normal renal function.
- Trial name
- NCT03289208
- Testing
- MCI-186
- Where
- Japan
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Shionogi
Mild Cognitive Impairment (MCI), Alzheimer's Disease (AD)
A Clinical Study Evaluating the Diagnostic Performance and Safety of PET for the Deposition of Aβ Plaques in the Brain of Participants With Normal Cognitive Function, MCI and AD Using [18F]Fluorbetazine Injection
A multicenter phase III clinical study evaluating the diagnostic performance and safety of PET for the deposition of Aβ plaques in the brain of participants with normal cognitive function, MCI and AD using [18F]Fluorbetazine…
- Trial name
- NCT07764679
- Testing
- [18F]Fluorbetazine injection
- Where
- China
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- HTA Co., Ltd.
Severe Renal Impairment
A Phase 1 Study to Assess the Effect of Severe Renal Impairment on the Pharmacokinetics, as Well as Safety/Tolerability, of Ranolazine
The purpose of this study is to assess the effect of severe renal impairment on the steady-state PK, as well as safety and tolerability, of ranolazine, compared to subjects with normal renal function.
- Trial name
- NCT01675973
- Testing
- RANEXA
- Where
- United States
- Volunteers
- 4 people, healthy volunteers welcome
- Sponsor
- Gilead Sciences
Chronic Hepatitis B Infections
Single-Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Pevifoscorvir Sodium (ALG-000184) in Subjects With Moderate Hepatic Impairment and in Healthy Subjects With Normal Hepatic Function
This Phase 1 non-randomized, open-label, single-dose hepatic impairment study consists of 2 cohorts, conducted in 16 subjects, 8 subjects with moderate hepatic impairment (Cohort 1) and 8 subjects without hepatic impairment…
- Trial name
- NCT07342868
- Testing
- Pevifoscorvir Sodium (ALG-000184)
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Aligos Therapeutics
Type 2 Diabetes Mellitus
A Study to Assess the Pharmacokinetics, Pharmacodynamics of ASP1941 in Diabetes Mellitus Patients With Renal Impairment
The primary objective of this study is to compare the pharmacokinetics of ASP1941 in type 2 diabetes mellitus patients with normal renal function and those with mild or moderate renal impairment.
- Trial name
- NCT01097681
- Testing
- ASP1941
- Where
- 2 sites in Japan
- Volunteers
- 25 people
- Sponsor
- Astellas Pharma Inc
Hepatic Impairment
Assessment of the Single Dose Pharmacokinetics and Tolerability of Sativex in Patients With Impaired Hepatic Function and Healthy Patients
A Phase I open-label study to evaluate the pharmacokinetics (what the body does to a drug), safety and tolerability of a single dose of Sativex (containing 10.8 mg tetrahydrocannabinol [THC] and 10 mg cannabidiol [CBD]) in…
- Trial name
- NCT01887301
- Testing
- Sativex
- Where
- 2 sites in United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Jazz Pharmaceuticals
Pharmacokinetics of MDV3100, Healthy Subjects
Hepatic Impairment Study With MDV3100 in Subjects With Mild and Moderate Hepatic Impairment Compared to a Healthy Control Group
This study will assess the influence of hepatic impairment on the pharmacokinetics, safety and tolerability of a single dose of MDV3100 in male subjects. The study will consist of two treatment arms.
- Conditions
- Pharmacokinetics of MDV3100, Healthy Subjects, Kidney Diseases
- Trial name
- NCT01901133
- Testing
- MDV3100
- Where
- Moldova
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Europe B.V.
Renal Impairment
The Study is to Investigate D-2570 in Participants With Different Levels of Kidney Function.
This study is divided two parts into: Part A and Part B. Part A will recruit 24 research participants, and Part B will recruit 16 research participants.
- Trial name
- D2570-107 (NCT07715175)
- Testing
- D-2570
- Where
- China
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- InventisBio Co., Ltd
Advanced Malignancies
To Evaluate the Safety, and Pharmacokinetics of Parscaclisib in Participants With Normal Hepatic Function and Hepatic Impairment.
The purpose of the study is to evaluate the pharmacokinetics and safety of parsaclisib in participants With normal hepatic function and participants with hepatic impairment.
- Trial name
- NCT04831944
- Testing
- parsaclisib
- Where
- 5 sites in United States
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- Incyte Corporation
Renal Impairment, Healthy Volunteers
A Study of Mobocertinib Capsules in People With Severe Kidney Problems and People With Healthy Kidneys
It is hoped that mobocertinib will eventually help people with cancer with severely reduced kidney function. The main aim of this study is to learn about the levels of mobocertinib in the blood and urine of participants with…
- Trial name
- NCT04056455
- Testing
- Mobocertinib
- Where
- 2 sites in United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Millennium Pharmaceuticals, Inc.
Renal Insufficiency
Study to Evaluate Safety and Tolerability of Iberdomide (CC-220) in Participants With Kidney Impairment Compared to Participants With Normal Kidney Function
This is an open-label study of iberdomide in participants with severe renal impairment or participants receiving dialysis compared to participants with normal renal function.
- Trial name
- NCT04933747
- Testing
- Iberdomide
- Where
- 3 sites in United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Celgene
Hepatic Impairment, Advanced Malignant Solid Tumor
A Study to Compare the Blood Levels and Safety of Tazemetostat in Participants With Advanced Cancer and Moderate/Severe Liver Impairment to Participants With Advanced Cancer and Normal Liver Function
This main aim of this trial will be to study the blood levels (known as pharmacokinetics) of the study drug tazemetostat. The pharmacokinetics of the study drug in participants with advanced solid tumors and moderate or severe…
- Trial name
- NCT04241835
- Testing
- Tazemetostat
- Where
- 14 sites in United States, Belgium and 3 more
- Volunteers
- 18 people
- Sponsor
- Epizyme, Inc.
Migraine
Pharmacokinetic Single Dose Study of Oral Lasmiditan in Participants With Normal and Impaired Hepatic Function
This is a multicenter, open-label, non-randomized, parallel-group, single dose study. This study will enroll up to 24 participants and will include 2 hepatic impaired participant groups and one group of control participants with…
- Trial name
- NCT03040479
- Testing
- lasmiditan 200 mg
- Where
- 3 sites in United States, Canada
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Hepatic Impairment
A Study to Evaluate the Pharmacokinetics of the Hydrocodone Extended-Release Tablet (CEP-33237) in Subjects With Normal Hepatic Function and Subjects With Moderate Hepatic Impairment
The purpose of this study is: 1. To assess the pharmacokinetics of the hydrocodone bitartrate extended-release tablet in subjects with moderate hepatic impairment and in subjects with normal hepatic function. 2.
- Trial name
- NCT01319279
- Testing
- Hydrocodone bitartrate extended-release tablet
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Cephalon
Anaemia
Assessment of the Pharmacokinetics of GSK1278863 and Metabolites in Normal Subjects and Subjects With Renal Impairment
This will be an open-label, parallel-group study to evaluate the pharmacokinetics of GSK1278863 and metabolites in normal subjects and subjects with impaired renal function, including those who are hemodialysis dependent.
- Trial name
- NCT01406340
- Testing
- 5 mg GSK1278863
- Where
- 3 sites in United States
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hepatic Impairment
A Study to Assess the Effect of Hepatic Impairment on Safinamide Pharmacokinetics
The primary purpose of this study is to investigate the pharmacokinetics (behavior of the compound in the body) of safinamide in patients with different degrees of hepatic (liver) impairment in comparison to matched subjects with…
- Trial name
- NCT01027169
- Testing
- safinamide
- Where
- Germany
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Newron Pharmaceuticals SPA