Clinical trials: Severe Functional Impairment
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
Renal Impairment
Study of a Single Intravenous (IV) Dose of MK-3402 in Participants With Impaired Renal Function and in Healthy Controls (MK-3402-004)
The purpose of this study is to compare the plasma and urine pharmacokinetics (PK) of MK-3402 in participants with impaired renal function and healthy control participants, to investigate the extent to which MK-3402 is removed…
- Trial name
- NCT04678505
- Testing
- MK-3402
- Where
- 2 sites in United States
- Volunteers
- 9 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Gastrointestinal Cancer
Oxaliplatin With FOLFOX4 in Patients With Normal and Abnormal Renal Function
This trial is a phase II study in patients with advanced gastrointestinal (GI) malignancies who will be assigned to one of 4 cohorts (normal, mild, moderate and several renal dysfunction) based on their baseline measured…
- Trial name
- FOLFOX4 (NCT00094965)
- Testing
- Oxaliplatin (SR96669)
- Where
- United States
- Volunteers
- 43 people
- Sponsor
- Sanofi
Kidney Disease, Renal Insufficiency Chronic
A Study of Eloralintide (LY3841136) in Participants With Renal Impairment and in Participants With Normal Renal Function
The purpose of the study is to assess the amount of Eloralintide (LY3841136) that reaches the bloodstream and the time it takes for the body to get rid of it when given to participants with renal (kidney) impairment and to…
- Conditions
- Kidney Disease, Renal Insufficiency Chronic, Kidney Failure, Chronic, Renal Impairment
- Trial name
- NCT07426380
- Testing
- LY3841136
- Where
- 2 sites in United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Hepatitis C
To Assess the Effect of Renal Impairment on the Blood Levels of Daclatasvir (DCV), Asunaprevir (ASV) and BMS-791325 After Multiple Doses of a Fixed Dose Combination Tablet
Assess the effect of renal function on the blood levels of DCV, ASV, BMS-791325.
- Trial name
- NCT02108639
- Testing
- DCV 3DAA FDC, BMS-791325
- Where
- 4 sites in United States
- Volunteers
- 41 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
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.
Hepatitis C Virus
TMC435-TiDP16-C113: A Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics of TMC435
The purpose of the study is to investigate the effect of moderate and severe hepatic impairment on the pharmacokinetics of TMC435.
- Trial name
- NCT01046058
- Testing
- TMC435
- Where
- 3 sites in United States
- Volunteers
- 23 people, healthy volunteers welcome
- Sponsor
- Tibotec Pharmaceuticals, Ireland
Hyperlipidemia, Mixed Dyslipidemia
Estimation Study to Assess the Effect of Severe Renal Impairment and End-stage Renal Disease Hemodialysis on the Pharmacokinetics of Evolocumab
The primary objective of this study was to evaluate the pharmacokinetics of evolocumab after a single 140 mg subcutaneous (SC) dose in aduts with normal renal function or severe renal impairment or end-stage renal disease (ESRD)…
- Trial name
- NCT02275156
- Testing
- Evolocumab
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- Amgen
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
Hepatic Impairment
An Investigational Study of ESK-001 in Participants With Normal Liver Function and Participants With Mild, Moderate, and Severe Liver Damage
This a phase 1, open label, single dose, parallel cohort study to determine the pharmacokinetics (PK) of study drug (ESK-001) in healthy volunteer participants, and participants with mild, moderate, and severe hepatic impairment.
- Trial name
- NCT06952634
- Testing
- envudeucitinib
- Where
- 4 sites in United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Alumis Inc
Liver Dysfunction, Healthy Volunteers
An Investigational Study of BMS-986165 in Participants With Normal Liver Function and Participants With Mild to Severe Liver Damage
The purpose of this study is to investigate BMS-986165 in participants with different levels of liver function.
- Trial name
- NCT03890809
- Testing
- BMS-986165
- Where
- 4 sites in Czechia, Hungary and 1 more
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
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
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
Renal Impairment
A Pharmacokinetic Study of Saroglitazar Magnesium in Subjects with Severe Renal Impairment and Normal Renal Function
This will be a Phase 1, Open-label Study of Participants with Normal Renal Function and Participants with Sever Renal Impairment.
- Trial name
- NCT04446507
- Testing
- Saroglitazar magnesium
- Where
- 2 sites in United States
- Volunteers
- 32 people
- Sponsor
- Zydus Therapeutics Inc.
Early Intervention, Child of Impaired Parents
VIA Family - Family Based Early Intervention Versus Treatment as Usual
This RCT aims to investigate the effect of an early family-based intervention (VIA Family) focusing on reducing risk and increasing resilience for children in families where at least one parent has a severe mental illness.The…
- Conditions
- Early Intervention, Child of Impaired Parents, Child, Adolescent
- Trial name
- NCT03497663
- Testing
- VIA Family intervention, Treatment As Usual
- Where
- Denmark
- Volunteers
- 96 people, healthy volunteers welcome
- Sponsor
- Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
Hepatic Impairment
Assessment of Quizartinib Pharmacokinetic in Subjects With Severe Hepatic Impairment
This study will evaluate and compare the PK in subjects with severe HI to that of matched healthy control subjects with normal hepatic function.
- Trial name
- NCT06740799
- Testing
- Quizartinib
- Where
- 3 sites in United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Daiichi Sankyo
Cerebral Palsy, Arthrogryposis
Effects of Power Mobility on Young Children With Severe Motor Impairments
The purpose this study is to determine the effects of power mobility on the development and function of young children of young children whose severe physical disabilities limit their exploratory behaviors and may unnecessarily…
- Conditions
- Cerebral Palsy, Arthrogryposis, Spinal Muscular Atrophy, Other Central Nervous System or Musculoskeletal Disorders
- Trial name
- NCT01028833
- Testing
- Power mobility
- Where
- United States
- Volunteers
- 41 people
- Sponsor
- University of Oklahoma
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
Hepatic Function Abnormal
A Study in Adults to Investigate the Impact of Mild, Moderate, and Severe Hepatic Impairment on Pharmacokinetics of Venglustat Compared to Participants With Normal Hepatic Function
This is a parallel, Phase 1, four arm, open-label, single dose, multicenter study to evaluate the impact of hepatic impairment on venglustat exposure following treatment with venglustat.
- Trial name
- NCT05718258
- Testing
- Venglustat (GZ402671)
- Where
- 6 sites in United States, Germany
- Volunteers
- 26 people
- Sponsor
- Sanofi
Renal Impairment
A Study to Evaluate ID-085 in People With Mild, Moderate, and Severe Kidney Disease
The primary objective of this study is to evaluate the pharmacokinetics (PK), tolerabilty and safety of a single dose of ID-085 in subjects with mild, moderate, and severe renal function impairment compared to healthy subjects
- Trial name
- NCT03913000
- Testing
- ID-085
- Where
- Germany
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Idorsia Pharmaceuticals Ltd.