Clinical trials: Normal Physiology
Gout, Hyperuricemia
PK and Safety Evaluation Study of SAP-001 in Adult Subjects With Normal and Impaired Renal Function
This is a multicenter, open-label, non-randomized, parallel-group, single-dose, 2-part, adaptive study in which up to approximately 32 adult subjects will be enrolled in one of 4 groups (8 subjects per group) with varying degrees…
- Trial name
- NCT06729853
- Testing
- SAP-001
- Where
- 2 sites in United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Shanton Pharma Pte. Ltd.
Healthy Volunteer
A Study of Danoprevir in Healthy Volunteers And Patients With Hepatic Impairment
This non-randomized, multi-center, open-label study will evaluate the pharmacokinetics and the safety and tolerability of danoprevir (RO5190591) and ritonavir in healthy volunteers and patients with mild, moderate or severe…
- Trial name
- NCT01185873
- Testing
- danoprevir, ritonavir
- Where
- 5 sites in United States, Czechia and 1 more
- Volunteers
- 81 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Kidney Diseases, Hyponatremia
Study to Compare Conivaptan Pharmacokinetics in Subjects With Mild & Moderate Kidney Function Impairment to Subjects With Normal Kidney Function
A study to compare a conivaptan PK in subjects with mild or moderate kidney function impairment to subjects with normal kidney function after a 48-hour continuous infusion of conivaptan.
- Trial name
- NCT00887627
- Testing
- conivaptan hydrochloride
- Where
- United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Cumberland Pharmaceuticals
Hepatic; Functional Disturbance
Open-label Study to Assess the Pharmacokinetics of NKTR-118 in Patients With Impaired Hepatic Function
The purpose of this study is to assess the pharmacokinetics of NKTR-118 in patients with impaired hepatic function versus subjects with normal hepatic function.
- Trial name
- NCT01392807
- Testing
- NKTR-118
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Atopic Dermatitis
Dupilumab-pediatric Skin Barrier Function and Lipidomics Study in Patients With Atopic Dermatitis in China
This is a 32-week, open-label, exploratory study with a 4-week screening period, 16-week treatment phase designed to investigate dupilumab's effect on skin barrier function as measured by TEWL before and after STS in…
- Trial name
- PELISTAD CN (NCT05680298)
- Testing
- Dupilumab
- Where
- China
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Sanofi
Hepatic Impairment
A PK Study Testing Single Oral Dose of Elacestrant in Subjects With Normal or Severely Impaired Hepatic Function
This is a Phase 1, multi-center, open-label, non-randomized, parallel group study to evaluate the effect of severe hepatic impairment on the PK, safety and tolerability of a single oral dose of Elacestrant.
- Trial name
- NCT06126575
- Testing
- Elacestrant dihydrochloride
- Where
- 3 sites in United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Stemline Therapeutics, Inc.
Healthy, Renal Dysfunction
Study of Danicopan in Participants With Normal Kidney Function and Participants With Kidney Dysfunction
This was an open-label, nonrandomized, multi-center, single-dose, parallel group study to evaluate the effect of severe renal impairment (RI) on the safety, tolerability, pharmacokinetics, and pharmacodynamics of danicopan…
- Trial name
- NCT04935294
- Testing
- Danicopan
- Where
- 4 sites in United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Alexion Pharmaceuticals, Inc.
Contrast Enhancement in Magnetic Resonance Imaging
A Study to Evaluate the Pharmacokinetics (How it Moves Into, Through and Out From the Body) of a New Gadolinium-based Contrast Agent (GBCA) After Injection and How Safe it is in Participants With Normal and Impaired Renal Function
Researchers in this study want to learn how a new contrast agent for magnetic resonance imaging (MRI) called BAY1747846 moves into, through and out of the body (pharmacokinetics) after injection in participants with normal and…
- Trial name
- NCT05061979
- Testing
- BAY1747846
- Where
- 2 sites in United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Bayer
Renal Impairment, Healthy
A Study to Learn How the Body Processes the Study Medicine PF-07328948 in People With Reduced Kidney Function
The purpose of this study is to learn how the study medicine PF-07328948 is processed by the body and how safe and tolerable it is in adults with different levels of kidney function.
- Trial name
- NCT07315360
- Testing
- PF-07328948
- Where
- 4 sites in United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Pfizer
Hepatic Impairment, Healthy Volunteers
A Study of HDM1002 in Subjects With And Without Varying Degrees Of Hepatic Impairement
The current study is proposed to evaluate whether there is any clinically meaningful effect of hepatic impairment on the plasma Pharmacokinetic (PK) of HDM1002
- Trial name
- NCT06985615
- Testing
- Single dose of HDM1002 on Day 1
- Where
- China
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
Hepatic Impairment
A Study to Evaluate the Effect of Hepatic Impairment on the Pharmacokinetics of Glasdegib
This is a Phase 1, open-label, parallel group, single dose study to investigate the effect of moderate or severe hepatic impairment on the PK of glasdegib, compared to subjects with normal hepatic function.
- Trial name
- NCT03627754
- Testing
- Glasdegib 100 mg single oral dose
- Where
- 3 sites in United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Pfizer
Hepatic Impairment, Healthy Volunteers
A Research Study Looking at How a Single Dose of the Study Medicine NNC0194-0499 Behaves in Participants With Reduced Liver Function Compared to Participants With Normal Liver Function
The study medicine NNC0194-0499 is under development for non-alcoholic fatty liver disease (NAFLD) including non-alcoholic steatohepatitis (NASH).
- Trial name
- NCT05917938
- Testing
- NNC0194-0499
- Where
- 5 sites in Germany, Poland and 1 more
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- Novo Nordisk A/S
Type 2 Diabetes
A Study of the Pharmacokinetics, Pharmacodynamics, and Safety of Rongliflozin in Type 2 Diabetic Subjects With Renal Impairment
To evaluate the pharmacokinetic characteristics of pyroglutamate rongliflozin capsules in type 2 diabetic subjects with normal renal function and mild to moderate renal impairment.
- Trial name
- NCT05374343
- Testing
- pyroglutamate rongliflozin capsules
- Where
- China
- Volunteers
- 32 people
- Sponsor
- Sunshine Lake Pharma Co., Ltd.
Schizophrenia, Hepatic Impairment
A Study of the Pharmacokinetics of Paliperidone in Volunteers With Normal or Impaired Liver Function
The purpose of this study is 1) to investigate the single-dose pharmacokinetics of immediate release (IR) paliperidone, after oral administration, in patients having moderate hepatic impairment compared to patients having normal…
- Trial name
- NCT00791284
- Testing
- Intermediate release (IR) Paliperidone
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Renal Impairment
Pharmacokinetics and Safety of ALKS 5461 in Subjects With Renal Impairment and Normal Renal Function
This study will evaluate the effect of various degrees of renal function on the pharmacokinetics and safety of ALKS 5461.
- Trial name
- NCT02508506
- Testing
- ALKS 5461
- Where
- 3 sites in United States
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Alkermes, Inc.
Hepatic Impairment, Healthy Participants
Safety and Pharmacokinetics Study of Linzagolix in Female Subjects With Normal and Impaired Hepatic Function
The primary objective of this study is to assess the pharmacokinetics (PK) of linzagolix in subjects with varying degrees of impaired hepatic function compared to match control subjects with normal hepatic function
- Trial name
- NCT03962049
- Testing
- Linzagolix
- Where
- 2 sites in United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- ObsEva SA
Rosacea, Systemic Inflammation
Effects of Oral Supplement Containing L-Histidine and Antioxidants on the Skin Barrier Function and Systemic Inflammation in Rosacea
The purpose of this study is to evaluate how supplementation will alter the skin and the gut barrier and inflammation in those with rosacea.
- Trial name
- NCT06072066
- Testing
- Skin Barrier Oral Supplement
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Integrative Skin Science and Research
Renal Insufficiency, Kidney Disease
A Study to Evaluate the Pharmacokinetics Of Sativex® in Subjects With Severe Renal Impairment or End Stage Renal Disease, Compared to Matched Subjects With Normal Renal Function.
The study aims to determine the pharmacokinetic (PK) profile of a single oromucosal dose of Sativex® (i.e. how the body absorbs, distributes, metabolises and excretes the drug) when subjects have severe renal impairment or end…
- Trial name
- NCT02325024
- Testing
- Sativex
- Volunteers
- healthy volunteers welcome
- Sponsor
- GW Pharmaceuticals Ltd
Pharmacokinetics of Vepoloxamer, Healthy Volunteers
Study of the Effect of Renal Impairment on the Pharmacokinetics of Vepoloxamer
This is an open-label study designed to evaluate the effect of renal disease on the pharmacokinetics of vepoloxamer relative to the pharmacokinetics in healthy subjects with normal renal function.
- Conditions
- Pharmacokinetics of Vepoloxamer, Healthy Volunteers, Renal Impaired
- Trial name
- NCT02646358
- Testing
- Vepoloxamer
- Where
- 2 sites in United States
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- Mast Therapeutics, Inc.
Systemic Lupus Erythematosus
Effect of Simvastatin on Endothelial Function in Premenopausal Women With Systemic Lupus Erythematosus (0733-271)(TERMINATED)
Women with Systemic Lupus Erythematosus (SLE) are prone to cardiovascular disease. Early detection of improvement of endothelial function with simvastatin could be a clue for future intervention trials.
- Trial name
- NCT00739050
- Testing
- simvastatin
- Volunteers
- 4 people
- Sponsor
- Organon and Co