Clinical trials: Impairment
Healthy Volunteer
A Study of The Effect of Hepatic Impairment on The Pharmacokinetics of Aleglitazar
This open-label study will assess the effects of hepatic impairment on the pharmacokinetics of a single oral dose of aleglitazar in subjects with mild or moderate hepatic impairment (Child-Pugh class A or B) and in matched…
- Trial name
- NCT01197911
- Testing
- aleglitazar
- Where
- 2 sites in United States
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Congestive Heart Failure
Study to Evaluate the Effect of SLV320 in Addition to Chronic Furosemide Treatment on Renal Function in Subjects With Congestive Heart Failure and Impaired Renal Function
This is a randomized, double-blind, placebo-controlled, multi-center, sequential cohort study in subjects with congestive heart failure (CHF) and impaired renal function who are on stable furosemide treatment (³ 40 mg daily).
- Trial name
- NCT00568009
- Testing
- SLV320
- Where
- 72 sites in United States, Argentina and 8 more
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Solvay 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
Idiopathic Thrombocytopenic Purpura
Study of the Safety and Immunogenicity of Long-term GNR-069 Therapy in ITP Patients
It is a phase III extension study to assess safety and immunogenicity of long-term therapy with GNR-069 in patients with idiopathic thrombocytopenic purpura
- Trial name
- NCT05492409
- Testing
- GNR-069
- Where
- 13 sites in Russia
- Volunteers
- 160 people
- Sponsor
- AO GENERIUM
Hepatic Impairment, Healthy
Pharmacokinetics Study of MCI-186 in Subjects With Mild or Moderate Hepatic Impairment
To assess the pharmacokinetics of MCI-186 after a single intravenous infusion of 30mg/hour in subjects with mild or moderate Hepatic impairment compared to subjects with normal hepatic function
- Trial name
- NCT03289234
- Testing
- MCI-186
- Where
- 2 sites in Japan
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Shionogi
Mild Cognitive Impairment, Alzheimer's Disease
Aftobetin-HCl and Fluorescence Detection Measured by Sapphire II to Determine the Number and Timing of Administrations
This is an open-label study to evaluate Aftobetin-HCl and florescence detection as measured by the Sapphire II device. Performance of Part I of the study has been completed (15 subjects received a single administration of…
- Trial name
- NCT02928211
- Testing
- Sapphire II, Aftobetin-HCl, Positron Emission Tomography
- Where
- United States
- Volunteers
- 105 people, healthy volunteers welcome
- Sponsor
- Cognoptix, Inc.
Hepatic Impairment
EVP-6124 Hepatic Impairment Study
The purpose of this study is to assess the pharmacokinetics of EVP-6124 and metabolites after a single oral dose in subjects with mild, moderate and severe hepatic impairment compared with subjects with normal hepatic function.
- Trial name
- NCT01984736
- Testing
- Experimental: EVP-6124
- Where
- 3 sites in Czechia, Poland and 1 more
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- FORUM Pharmaceuticals Inc
Type 2 DM Patients With Moderate or Severe Renal Impairment
A Phase IIIb Study to Evaluate the Safety and Efficacy of Gemigliptin in Type 2 Diabetes Mellitus Patients With Moderate or Severe Renal Impairment(GUARD Study)
Therapuetic options are limited for Type 2 Diabetes Mellitus (T2DM) pateints with renal impairment. This clinical study is to asses safety and efficacy of the DPP-4 inhibitor gemigliptin in patients with type 2 DM and moderate or…
- Trial name
- GUARD (NCT01968044)
- Testing
- Gemigliptin
- Where
- South Korea
- Volunteers
- 132 people
- Sponsor
- LG Life Sciences
Hepatic Impairment
A Study to Evaluate the Pharmacokinetics, Safety, and Pharmacodynamics of Olpasiran in Participants With Various Degrees of Hepatic Impairment
The primary objective of the study is to evaluate the pharmacokinetics (PK) of a single dose of olpasiran in participants with mild, moderate, or severe hepatic impairment compared to participants with normal hepatic function.
- Trial name
- NCT05481411
- Testing
- Olpasiran
- Where
- 3 sites in United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Amgen
Renal Insufficiency
PK Study of ACHN-490 Injection in Renally Impaired Subjects
The purposes of this study is to assess the relationship between renal function and pharmacokinetics of ACHN-490 Injection.
- Trial name
- NCT01462136
- Testing
- ACHN-490 Injection
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Achaogen, Inc.
Alzheimer's Disease
Evaluation of Safety & Tolerability of Multiple Dose Regimens of CHF 5074
To evaluate the safety and tolerability of ascending oral doses of CHF 5074 administered once per day for up to 12 weeks to patients with mild cognitive impairment.
- Trial name
- CT04 (NCT01303744)
- Testing
- CHF 5074 1x, CHF 5074 2x, CHF 5074 3x
- Where
- 9 sites in United States, Italy
- Volunteers
- 96 people
- Sponsor
- CERESPIR
Chronic Kidney Disease
A Research Study Looking Into Levels of the Medicine NNC0385-0434 in the Body and How Well it is Tolerated in Participants With Impaired Kidney Function Compared to Participants With Normal Kidney Function
Novo Nordisk is developing a new medicine, NNC0385-0434, to help people lower their cholesterol level. The aim of this study is to look at how NNC0385-0434 works in the body and how it is removed from the body in people with…
- Trial name
- NCT05094934
- Testing
- NNC0385-0434 A 100 mg
- Where
- Germany
- Volunteers
- 60 people
- Sponsor
- Novo Nordisk A/S
Renal Impairment
A Study to Evaluate Pharmacokinetics (PK) and Safety of Inaxaplin in Participants With Renal Impairment
The purpose of this study is to evaluate the pharmacokinetics and safety of a single dose of Inaxaplin (IXP) in participants with severe renal impairment and healthy participants with normal renal function.
- Trial name
- NCT05865171
- Testing
- IXP
- Where
- 2 sites in United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Vertex Pharmaceuticals Incorporated
Long Bone Non-Union
Study on Autologous Osteoblastic Cells Implantation in Hypotrophic Non-Union Fractures
Fracture healing is a complex physiological process caused by interaction of cellular elements, cytokines and signaling proteins, which results in the formation of new bone (Gerstenfeld et al., 2003).
- Trial name
- NCT01756326
- Testing
- PREOB® Implantation, Bone Autograft
- Where
- 16 sites in Belgium, France and 1 more
- Volunteers
- 5 people
- Sponsor
- Bone Therapeutics S.A
Solid Tumours
Study to Assess the Blood Levels and Safety of Olaparib in Patients With Advanced Solid Tumours and Normal Liver Function or Mild or Moderate Liver Impairment
This is a 2-part study in patients with advanced solid tumours. Part A will investigate the PK of olaparib in patients with mild or moderate hepatic impairment compared to patients with normal hepatic function; Part B will allow…
- Trial name
- NCT01894243
- Testing
- Olaparib tablet dosing
- Where
- 12 sites in Czechia, France and 3 more
- Volunteers
- 31 people
- Sponsor
- AstraZeneca
Pain
A Study Of GW406381 In Volunteers With Moderate Hepatic Impairment
This study will assess the pharmacokinetics and tolerability of a single dose of GW406381 in subjects with moderate hepatic impairment in comparison to matched healthy volunteers.
- Trial name
- NCT00373243
- Testing
- GW406381
- Where
- 2 sites in Hungary
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Pruritus
Phase I Study of Linerixibat in Adults With Moderate Hepatic Impairment and Healthy Controls
This is a phase 1, open-label, single-dose study in adults with moderate hepatic impairment (defined as Child-Pugh B cirrhosis) and matched healthy control participants with normal hepatic function.
- Trial name
- NCT05393076
- Testing
- Linerixibat
- Where
- 2 sites in United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Mild Cognitive Impairment, Alzheimer's Disease
A Validation Study of the Novel Application of Telehealth in Clinical Drug Development in Subjects With Mild Cognitive Deficits
REINVENT is a non-interventional, multi-center, research network-based cross-over study evaluating the potential utility of a telehealth platform in improving the efficiency of clinical trials.
- Trial name
- REINVENT (NCT02778438)
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Quintiles, Inc.
Vaccine Response Impaired, Vaccine Adverse Reaction
Vaccine Observation to Include All Communities for Equitable Science
VOICES is a longitudinal, prospective, observational study that will enroll up to 10,000 subjects of diverse racial backgrounds being administered an emergency use authorized COVID-19 vaccine, for collection and analysis of stool…
- Trial name
- VOICES (NCT04770649)
- Testing
- COVID-19 vaccine
- Where
- United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Persephone Biosciences
Healthy, Liver Diseases
A Study to (1) Compare How BI 456906 is Taken up in the Body of Healthy People and People With Liver Problems and (2) Find Out How People With Overweight and Obesity, With and Without Liver Problems, Tolerate Different Doses of BI 456906
This study is open to adults who have different levels of liver problems and adults who are healthy. People with or without overweight or obesity can take part. This study has 2 parts.
- Conditions
- Healthy, Liver Diseases, Obesity
- Trial name
- NCT05296733
- Testing
- BI 456906
- Where
- 13 sites in United States, Germany and 4 more
- Volunteers
- 82 people
- Sponsor
- Boehringer Ingelheim
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