Clinical trials: Drug Kinetics
Metastatic Prostate Cancer
64Cu-TLX592 Phase I Safety, PK, Biodistribution and Dosimetry Study (CUPID Study)
This is a Phase 1 trial of TLX592, a humanised, engineered monoclonal antibody HuX592r conjugated with a DOTA chelator and radiolabelled with 64Cu (64Cu-TLX592).
- Trial name
- CUPID (NCT04726033)
- Testing
- 64Cu-DOTA-TLX592
- Where
- 2 sites in Australia
- Volunteers
- 14 people
- Sponsor
- Telix Pharmaceuticals (Innovations) Pty Limited
Dravet Syndrome
A Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Fenfluramine (Hydrochloride) in Infants 1 Year to Less Than 2 Years of Age With Dravet Syndrome
The primary purpose of this study is evaluate the safety and tolerability of fenfluramine hydrochloride (HCl) 0.2 to 0.8 mg/kg/day in infants 1 year to less than 2 years of age with Dravet syndrome.
- Trial name
- ORCHID (NCT06118255)
- Testing
- fenfluramine
- Where
- 12 sites in United States, Belgium and 3 more
- Volunteers
- 25 people
- Sponsor
- UCB BIOSCIENCES, Inc.
Hypoplasminogenemia, Congenital Plasminogen Deficiency
A Study of Prometic Plasminogen IV Infusion in Subjects With Hypoplasminogenemia
This is a Phase 2/3 pivotal study to evaluate pharmacokinetics (PK), efficacy, and safety of Prometic Plasminogen (Human) Intravenous Lyophilized Solution, the investigational medicinal product (IMP), in pediatric and adult…
- Trial name
- NCT02690714
- Testing
- Plasminogen (Human) intravenous
- Where
- 2 sites in United States, Norway
- Volunteers
- 15 people
- Sponsor
- Prometic Biotherapeutics, Inc.
Acute Pain
Pharmacokinetics and Safety of MNK-155 in Postsurgical Adolescent Subjects With Moderate to Severe Acute Pain
An open-label study of the pharmacokinetics (PK) and safety of MNK-155 in postsurgical adolescent subjects aged 12 to 17 years with moderate to severe acute pain.
- Trial name
- NCT02767349
- Testing
- MNK-155
- Where
- United States
- Sponsor
- Mallinckrodt
Congenital Bleeding Disorder, Haemophilia A
A Multinational, Open-Label, Non-Controlled Trial on Safety, Efficacy and Pharmacokinetics of NNC 0129-0000-1003 in Previously Treated Paediatric Patients With Severe Haemophilia A
This trial is conducted globally. The aim of the trial is to investigate safety, efficacy and pharmacokinetics (the exposure of the trial drug in the body) of NNC 0129-0000-1003 (N8-GP) in children with severe haemophilia A who…
- Trial name
- pathfinder™5 (NCT01731600)
- Testing
- turoctocog alfa pegol
- Where
- 51 sites in United States, Brazil and 14 more
- Volunteers
- 68 people
- Sponsor
- Novo Nordisk A/S
Attention Deficit Hyperactivity Disorder
Open-label, Single-dose Trial to Assess the Pharmacokinetics of Centanafadine Extended-release Capsules in Pediatric Participants With Attention-deficit Hyperactivity Disorder (ADHD)
With the pharmacokinetics (PK) of centanafadine currently being evaluated in adults. The PK of extended-release centanafadine may differ in children compared to adults due to physiological differences in the gastrointestinal…
- Trial name
- NCT04081363
- Testing
- Centanafadine
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
GM2 Gangliosidosis, Niemann-Pick Type C Disease
A Study to Evaluate the Safety and Efficacy of Nizubaglustat (AZ-3102) in Patients With GM2 Gangliosidosis or Niemann-Pick Type C Disease
This open-label study aims to gather long-term safety, tolerability, PK, biomarker, and clinical efficacy data relating to daily administration of Nizubaglustat in participants previously enrolled in the Phase 2 RAINBOW study…
- Trial name
- PRISMA (NCT07399704)
- Testing
- AZ-3102
- Where
- 3 sites in Brazil
- Volunteers
- 21 people
- Sponsor
- Azafaros B.V.
HIV Infections
Pharmacokinetics and Safety Study of Tipranavir in Combination With Low Dose Ritonavir in Human Immunodeficiency Virus (HIV)-Infected Children
The primary objective of this study is to assess the safety and tolerability of tipranavir (TPV) oral formulation and soft gelatin capsules together with low-dose ritonavir in HIV-infected children and adolescents, to provide…
- Trial name
- NCT00076999
- Testing
- TPV oral solution, RTV oral solution
- Where
- 30 sites in United States, Argentina and 8 more
- Volunteers
- 115 people
- Sponsor
- Boehringer Ingelheim
Influenza a
Pharmacokinetics，Safety and Efficacy of ZSP1273 in Children 2-17 Years Old With Influenza A
This trial is conducted in China. The aim of the trial is to investigate safety,pharmacokinetics and pharmacodynamics of ZSP1273 granules
- Trial name
- NCT06656026
- Testing
- ZSP1273 granules
- Where
- China
- Volunteers
- 72 people
- Sponsor
- Guangdong Raynovent Biotech Co., Ltd
Lupus Erythematosus, Systemic
Personalised Pharmacological Approach to the Tapering of Corticosteroid Doses in Systemic Lupus Patients Treated With Prednisone
This research study is a multicentre prospective pharmacokinetic study. The clinical and biological data will be collected in the framework of a prospective study.
- Trial name
- DECOR (NCT03187743)
- Testing
- Blood samples
- Where
- France
- Volunteers
- 72 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Fabry Disease
A Study to Learn About the Safety and Effects of the Study Drug PRX-102 in Children and Adolescents With Fabry Disease
A Study to Learn About the Safety and Effects of the Study Drug PRX-102 in Children and Adolescents with Fabry Disease.
- Trial name
- FLY (NCT06328608)
- Testing
- PRX-102 1 mg/kg every two weeks
- Where
- 12 sites in United States, Austria and 4 more
- Volunteers
- 22 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Sickle Cell Disease (SCD)
Pharmacokinetics and Pharmacodynamics Study of SEG101 (Crizanlizumab) in Sickle Cell Disease (SCD) Patients With Vaso- Occlusive Crisis (VOC)
The purpose of the CSEG101A2202 study was to characterize the Pharmacokinetic (PK) and Pharmacodynamic (PD) of SEG101/crizanlizumab and to evaluate the safety and efficacy of SEG101/crizanlizumab in sickle cell disease (SCD)…
- Trial name
- NCT03264989
- Testing
- crizanlizumab
- Where
- 12 sites in United States
- Volunteers
- 57 people
- Sponsor
- Novartis Pharmaceuticals
Heart Failure, Left Ventricular Systolic Dysfunction
Efficacy, Safety, and Pharmacokinetics of Vericiguat in Pediatric Participants With Heart Failure Due to Left Ventricular Systolic Dysfunction (MK-1242-036)
This study aims to compare the efficacy of vericiguat versus placebo on change in n-terminal pro-brain natriuretic peptide (NTproBNP) from baseline to Week 16 of the Base Period.
- Trial name
- NCT05714085
- Testing
- Vericiguat tablet, Vericiguat suspension
- Where
- 111 sites in United States, Belgium and 28 more
- Volunteers
- 342 people
- Sponsor
- Merck Sharp & Dohme LLC
HIV Infections
A Phase I Study of the Safety and Pharmacokinetics of Recombinant CD4 (rCD4) in Infants and Children Infected With or at Risk for HIV Infection
AMENDED: As of 10/19/90 only Children 0 to 3 months are being enrolled. Original design: To determine whether the experimental drug recombinant CD4 (rCD4), which is produced through genetic engineering technology, is safe and…
- Trial name
- NCT00000984
- Testing
- CD4 Antigens
- Where
- 6 sites in United States
- Volunteers
- 40 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Duchenne Muscular Dystrophy (DMD)
A Study to Evaluate the Safety and Tolerability of RAG-18 in Pediatric Patients With Duchenne Muscular Dystrophy
This is an open-label, single-arm, dose-escalation trial to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of RAG-18 in pediatric patients with Duchenne Muscular…
- Trial name
- NCT07282652
- Testing
- RAG-18
- Where
- China
- Volunteers
- 12 people
- Sponsor
- Peking Union Medical College Hospital
Adolescence Obesity
Phase Ib Study of Efsubaglutide Alfa Injection in Obese Adolescents
This is a Phase Ib, randomized, double-blind, placebo-controlled clinical study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of Efsubaglutide Alfa Injection following multiple-dose…
- Trial name
- NCT07693426
- Testing
- Efsubaglutide Alfa 5 mg QW, Efsubaglutide Alfa 10 mg QW, Efsubaglutide Alfa 20 mg QW
- Where
- 5 sites in China
- Volunteers
- 36 people
- Sponsor
- Shanghai Yinnuo Pharmaceutical Technology Co., Ltd.
Constipation, Signs and Symptoms, Digestive
Phase I Pharmacokinetics and Safety Study of Naloxegol in Paediatric OIC Patients
To characterize the pharmacokinetics (PK) of naloxegol after single oral dose and through population PK in paediatric patients with opioid induced constipation (OIC) or at risk of OIC.
- Trial name
- NCT02099591
- Testing
- Naloxegol
- Where
- 16 sites in Denmark, Israel and 3 more
- Volunteers
- 61 people
- Sponsor
- Kyowa Kirin Pharmaceutical Development Ltd
Epidermolysis Bullosa
Topical BPM31510 3.0% Cream in Patients With Epidermolysis Bullosa
This is a single-center study to investigate the effects of a topical cream on patients 12 years of age and older that have been diagnosed with epidermolysis bullosa.
- Trial name
- NCT02793960
- Testing
- topical BPM31510 3.0% Cream
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- Shasa Hu
Muscular Atrophy, Spinal
Investigate Safety, Tolerability, PK, PD and Efficacy of Risdiplam (RO7034067) in Infants With Type1 Spinal Muscular Atrophy
Open-label, multi-center clinical study is to assess the safety, tolerability, pharmacokinetic (PK), pharmacodynamics (PD), and efficacy of Risdiplam (RO7034067) in infants with Type 1 spinal muscular atrophy (SMA).
- Trial name
- FIREFISH (NCT02913482)
- Testing
- Risdiplam
- Where
- 32 sites in United States, Belgium and 14 more
- Volunteers
- 62 people
- Sponsor
- Hoffmann-La Roche
Neonatal Abstinence Syndrome
The Pharmacokinetics of Oral Methadone in the Treatment of Neonatal Abstinence Syndrome
The chronic use of opiate medications during pregnancy is a major public health challenge. Prolonged exposure to opiates in utero may result in withdrawal symptoms in infants commonly referred to as neonatal abstinence syndrome…
- Trial name
- NCT01754324
- Testing
- Methadone
- Where
- 2 sites in United States
- Volunteers
- 20 people
- Sponsor
- Children's Hospital Medical Center, Cincinnati
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