Clinical trials: Pharmacodynamics
Obese Adolescents, Obesity
A Study of XW003 Injection in Chinese Adolescents With Obesity
The aim of the study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of XW003 injection in Chinese adolescents with obesity
- Trial name
- NCT07143227
- Testing
- XW003 injection
- Where
- China
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Hangzhou Sciwind Biosciences Co., Ltd.
Healthy
Study of ALXN1820 in Healthy Adult Participants
This is a Phase 1, randomized, double-blind, placebo-controlled single and multiple ascending dose study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of ALXN1820…
- Trial name
- NCT04631562
- Testing
- ALXN1820 SC, ALXN1820 IV
- Where
- 3 sites in Australia, United Kingdom
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- Alexion Pharmaceuticals, Inc.
Healthy Volunteers, Propionic Acidemia
A First in Human, Dose Escalation Study to Evaluate the Safety and Tolerability of BBP-671 in Healthy Volunteers and Patients With Propionic Acidemia or Methylmalonic Acidemia
The purpose of this study is to assess the safety, tolerability, PK and PD of BBP-671 in healthy volunteers and patients with Propionic Acidemia or Methylmalonic Acidemia.
- Conditions
- Healthy Volunteers, Propionic Acidemia, Methylmalonic Acidemia, Organic Acidemia
- Trial name
- NCT04836494
- Testing
- BBP-671
- Where
- 3 sites in United States
- Volunteers
- 79 people, healthy volunteers welcome
- Sponsor
- CoA Therapeutics, Inc., a BridgeBio company
Hypotension
Study to Determine the Pharmacokinetics and Pharmacodynamic Effects of Phenylephrine on BP Via IV
The primary objective of this study is to evaluate the dose effect of Phenylephrine Hydrochloride Injection on the treatment of clinically relevant decreased blood pressure in the pediatric population, ≥12 to 16 year old patients…
- Trial name
- NCT02323399
- Testing
- Phenylephrine
- Where
- 10 sites in United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- West-Ward Pharmaceutical
Gram Negative Infection, Antimicrobial Resistance (AMR)
PK/PD Analysis of Ceftazidime/Avibactam or Cefiderocol With or Without Fosfomycin for the Treatment of Difficult To-treat Gram-negative Infections
A multicenter, national, prospective, observational pharmacological study of patients with difficult-to-treat Gram-negative infections treated with ceftazidime/avibactam (CAZ/AVI) or cefiderocol (CEF) monotherapy or combination…
- Trial name
- PACCOF (NCT06651047)
- Where
- 11 sites in Italy
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- University of Bologna
Other
A Study of IW-6463 in Healthy Volunteers
Stage 1: To assess the safety and tolerability of single-ascending-dose levels of IW-6463 tablets when administered orally to healthy subjects Stage 2: To assess the safety and tolerability of multiple-ascending-dose levels of…
- Trial name
- NCT03856827
- Testing
- IW-6463
- Where
- Netherlands
- Volunteers
- 110 people, healthy volunteers welcome
- Sponsor
- Tisento Therapeutics
Osteoporosis
Assessment of Anti-RANKL Antibody in Post-menopausal Women
This is a single-center, open-label, dose-escalating study to evaluate the safety, pharmacokinetics, immunogenicity, and preliminary efficacy of single dose subcutaneous injection of a fully human monoclonal antibody of receptor…
- Trial name
- NCT03242512
- Testing
- TK006
- Where
- China
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Jiangsu T-Mab Biopharma Co.,Ltd
Elevated Lipoprotein(a), Cardiovascular Diseases
Drug-drug Interaction Study to Evaluate the Effect of ISIS 681257 on Warfarin
This is a single center, open label, single sequence, two-treatment, two-period drug-drug interaction study to evaluate the effect of multiple doses of ISIS 681257 on the pharmacokinetics of a single dose of warfarin.
- Trial name
- NCT03426033
- Testing
- ISIS 681257, Warfarin
- Where
- Canada
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Akcea Therapeutics
Chronic Hepatitis B
A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Food Effect of Oral HRS5091 in Healthy Subjects and Chronic Hepatitis B Patients
The study is a randomized, Double-Blind, Placebo-Controlled study to evaluate the safety, tolerability and pharmacokinetics, pharmacodynamics and food effect of HRS5091.
- Trial name
- NCT04480294
- Testing
- HRS5091
- Where
- China
- Volunteers
- 108 people, healthy volunteers welcome
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Anesthesia
Pharmacokinetic/Pharmacodynamic Model of Propofol in Children
By measuring plasmatic concentration of propofol at different intervals during surgery of children aged 1 to 12 years old and measuring Bispectral Index (BIS) as a surrogate for cerebral activity, the investigators aim to create…
- Trial name
- NCT02544854
- Testing
- Propofol
- Where
- Chile
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Pontificia Universidad Catolica de Chile
Tay-Sachs Disease, Sandhoff Disease
A Multinational, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy, Pharmacodynamics, Pharmacokinetics, and Safety of Venglustat in Late-onset GM2
Primary Objectives: Primary population (adult participants with late-onset GM2 gangliosidosis): To assess the efficacy and pharmacodynamics (PD) of daily oral dosing of venglustat when administered over a 104-week period…
- Trial name
- AMETHIST (NCT04221451)
- Testing
- venglustat GZ402671
- Where
- 23 sites in United States, Argentina and 11 more
- Volunteers
- 75 people, healthy volunteers welcome
- Sponsor
- Genzyme, a Sanofi Company
Sickle Cell Disease
A Phase I/II Study of ITU512 in Healthy Participants and Patients With Sickle Cell Disease
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary food effect of ITU512 as well as the fetal hemoglobin (HbF)-inducing capacity of ITU512.
- Trial name
- NCT06546670
- Testing
- ITU512
- Where
- 14 sites in United States, Brazil and 1 more
- Volunteers
- 161 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Healthy
A Two Part Study to Assess Safety, PK, PD, and Food Effect of Oral HTL0016878
Phase 1, first in human, two-part, single centre, placebo-controlled, single and multiple ascending dose trial in healthy younger and elderly adult subjects, with an open-label, randomised, crossover arms to assess the effect of…
- Trial name
- NCT03244228
- Testing
- HTL0016878
- Where
- United Kingdom
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Nxera Pharma UK Limited
Primary Hyperoxaluria Type 1 (PH1)
Study of Lumasiran in Healthy Adults and Patients With Primary Hyperoxaluria Type 1
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single-ascending doses (SAD) and multiple-ascending doses (MAD) of lumasiran in healthy adult volunteers and subjects…
- Trial name
- NCT02706886
- Testing
- Lumasiran
- Where
- 9 sites in France, Germany and 3 more
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- Alnylam Pharmaceuticals
Cystic Fibrosis
Improving Treatment of Nontuberculous Mycobacterial Infection in Cystic Fibrosis
The purpose of this study is to determine antimycobacterial drug pharmacokinetics (PK) and pharmacodynamics (PD) in patients with cystic fibrosis (CF) to improve treatment of nontuberculous mycobacterial (NTM) lung disease.
- Trial name
- NCT02372383
- Testing
- Ethambutol, Rifampin, Azithromycin
- Where
- United States
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- University of Colorado, Denver
BIS, BIS-EEG
Deep Learning Framework for Continuous Depth of Anesthesia Forecasting
The integration of Artificial Intelligence (AI) in anesthesiology offers the potential to shift patient monitoring from reactive to predictive.
- Conditions
- BIS, BIS-EEG, Artifical Intelligence, Intraoperative
- Trial name
- NCT07536230
- Where
- Belgium
- Volunteers
- 115 people, healthy volunteers welcome
- Sponsor
- Universitair Ziekenhuis Brussel
Fetal Anesthesia
Pharmacokinetic and Pharmacodynamic Investigations of Fetal Anesthesia During Maternal Fetal Surgery
This study examines how three medications commonly used during fetal surgery, fentanyl, rocuronium, and atropine, behave in the fetus.
- Trial name
- NCT07571811
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Boston Children's Hospital
Healthy Volunteers.
AZD6423 SAD/MAD Study in Healthy Volunteers
This is a randomized, double-blind, placebo-controlled study of single and multiple ascending dosage levels of AZD6423 in healthy volunteers.
- Trial name
- AZD6423 (NCT01926366)
- Testing
- AZD6423
- Where
- United States
- Volunteers
- 175 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Lysosomal Storage Diseases
Cellular Pharmacodynamics of Small Molecules in Lysosomal Storage Disorders
The purpose of this study is to evaluate the effect of small molecule therapy in primary cells derived from patients with lysosomal storage disease.
- Trial name
- NCT03812055
- Where
- United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Lysosomal and Rare Disorders Research and Treatment Center, Inc.
Pain, Drug Effect
Development of a Morphine Pharmacokinetic and Pharmacodynamic Model for the Neonatal Population
This research aims to study what the baby's body does with morphine and how morphine works in the baby's body. One hundred newborn babies will be enrolled in this study.
- Trial name
- NCT03035578
- Testing
- Morphine
- Volunteers
- healthy volunteers welcome
- Sponsor
- The Hospital for Sick Children