Clinical trials: Pharmacokinetics
Neuroblastoma
Oral Liquid 13-cis-retinoic Acid (13-CRA)
An open label, randomised, multiple dose, cross-over relative bioavailability and pharmacokinetics trial of a novel oral liquid and capsule formulations of 13-CRA administered to patients from 0 months - < 21 years.
- Trial name
- My-CRA (NCT03291080)
- Testing
- Liquid 13-Cis Retinoic Acid, Extracted capsules 13-CRA
- Where
- 10 sites in United Kingdom
- Volunteers
- 20 people
- Sponsor
- Nova Laboratories Limited
HIV Infection, Malaria
Pharmacology of Antimalarial Therapy With or Without Antiretroviral Therapy
The purpose of this study is to see if taking nevirapine (NVP) for HIV changes the way artemether/lumefantrine (AL) works in children who are co-infected with both HIV and malaria.
- Trial name
- NCT01728961
- Testing
- Artemether/Lumefantrine (AL)
- Where
- 3 sites in Malawi, Uganda
- Volunteers
- 19 people
- Sponsor
- International Maternal Pediatric Adolescent AIDS Clinical Trials Group
Heart Septal Defects, Ventricular, Atrioventricular Septal Defect
Aberrations in Carnitine Homeostasis in Congenital Heart Disease With Increased Pulmonary Blood Flow
Infants with congenital heart disease and increased pulmonary blood flow have altered carnitine homeostasis that is associated with clinical outcomes; and L-carnitine treatment will attenuate these alterations and improve…
- Trial name
- L-carn (NCT01825369)
- Testing
- IV L-carnitine
- Where
- United States
- Sponsor
- University of California, San Francisco
Asthma
A Randomized Study To Evaluate The Efficacy And Safety Of An Investigational Drug In Adolescent And Adult Subjects With Asthma Uncontrolled on Non-steroidal Therapy.
This study is designed to determine if the investigational drug is effective and safe in individuals with asthma.
- Trial name
- NCT00603382
- Testing
- GW685698X
- Where
- 149 sites in United States, Bulgaria and 12 more
- Volunteers
- 599 people
- Sponsor
- GlaxoSmithKline
Meningitis
Pharmacokinetics and Safety of Meropenem in Infants Below 90 Days of Age With Probable and Confirmed Meningitis
This phase I-II multicenter international trial is designed to study the pharmacokinetics of meropenem and to characterize the safety profile of meropenem in the treatment of infants ≤ 90 days of postnatal age with probable or…
- Trial name
- NeoMero-2 (NCT01554124)
- Testing
- Meropenem
- Where
- United Kingdom
- Volunteers
- 51 people
- Sponsor
- PENTA Foundation
Centronuclear Myopathy
Early Phase Human Drug Trial to Investigate Dynamin 101 (DYN101) in Patients ≥ 16 Years With Centronuclear Myopathies
There are no available treatments aside from supportive care for patients with Centronuclear myopathy (CNM). This trial will assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD)/preliminary efficacy of…
- Trial name
- Unite-CNM (NCT04033159)
- Testing
- DYN101
- Where
- 8 sites in Belgium, Denmark and 4 more
- Volunteers
- 14 people
- Sponsor
- Dynacure
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.
Congenital Adrenal Hyperplasia, Classic Congenital Adrenal Hyperplasia
A Study in Pediatric Participants With Congenital Adrenal Hyperplasia (Balance-CAH)
The purpose of this study is to evaluate the safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of atumelnant treatment in pediatric participants with classic congenital adrenal hyperplasia (CAH).
- Trial name
- NCT07159841
- Testing
- Atumelnant
- Where
- 52 sites in United States, Argentina and 11 more
- Volunteers
- 153 people
- Sponsor
- Crinetics Pharmaceuticals Inc.
Chickenpox, Herpes Zoster
Famciclovir Oral Pediatric Formulation in Children 1-12 Years of Age With Varicella Zoster Infection
Varicella zoster virus causes chickenpox in children and shingles in adults. Chickenpox is usually a self-limiting illness characterized by fever and a rash.
- Trial name
- NCT00098046
- Testing
- famciclovir
- Where
- 5 sites in United States, Costa Rica and 2 more
- Volunteers
- 76 people
- Sponsor
- Novartis
Obesity, Childhood
Acetaminophen Dosing in Obese Adolescents
Although there are numerous studies investigating the pharmacokinetic properties of intravenous acetaminophen in infants and children with normal weight, there are none in the obese pediatric patient .
- Trial name
- NCT03192566
- Testing
- Tylenol
- Where
- United States
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Children's National Research Institute
Primary Immune Deficiency
Study to Evaluate the Pharmacokinetics, Efficacy, Tolerability, and Safety of Subcutaneous Human Immunoglobulin (Newnorm) in Patients With Primary Immunodeficiency Diseases
Prospective, open-label, single-arm, multicentre Phase 3 study to evaluate the pharmacokinetics, efficacy, tolerability, and safety of subcutaneous human immunoglobulin (Newnorm) in patients with primary immunodeficiency diseases
- Trial name
- NCT04640142
- Testing
- Newnorm
- Where
- 23 sites in United States, Germany and 5 more
- Volunteers
- 50 people
- Sponsor
- Octapharma
Secondary Hyperparathyroidism
Cinacalcet in Paediatric Secondary Hyperparathyroidism (SHPT) Due to Chronic Kidney Disease (CKD)
Twelve-month, multicenter, intra-subject controlled (retrospective-prospective), open-label, active-treatment study to evaluate the dose-response and pharmacokinetics (PK) of cinacalcet HCl for the treatment of Secondary…
- Trial name
- NCT01479088
- Testing
- Cinacalcet HCl
- Where
- 5 sites in Italy
- Volunteers
- 30 people
- Sponsor
- ENRICO VERRINA
Gaucher Disease, Type 1, Gaucher Disease, Type 3
Phase 1/2 Study of CAN103 in Subjects With Gaucher Disease
Gaucher disease is a rare lysosomal storage disorder caused by deficient activity of the enzyme acid β-glucosidase, causing glucosylceramide to accumulate within macrophages and leading to hepatosplenomegaly, anemia…
- Trial name
- NCT05447494
- Testing
- Low-dose CAN103, High-dose CAN103
- Where
- China
- Volunteers
- 40 people
- Sponsor
- CANbridge (Suzhou) Bio-pharma Co., Ltd.
Hemophilia A
Study of Pharmacokinetics, Efficacy and Safety of a Recombinant and Protein-Free Factor VIII (rAHF-PFM) in Hemophilia A Patients - A Continuation of Clinical Study 069901
The purpose of this study is to evaluate whether rAHF-PFM is safe and effective in the treatment of hemophilia A subjects. The study consists of 2 parts: Part 1 is a pharmacokinetic and safety study, and Part 2 is an evaluation…
- Trial name
- NCT00157053
- Testing
- Antihemophilic factor, recombinant, manufactured protein-free
- Where
- 24 sites in United States, Austria and 7 more
- Volunteers
- 82 people
- Sponsor
- Baxalta now part of Shire
HIV-1 Infections
Lopinavir/Ritonavir (LPV/r) Tablet in HIV Infected Children
To study the pharmacokinetics of low-dose lopinavir/ritonavir tablet in HIV-1 infected Thai children.
- Trial name
- NCT01139905
- Testing
- lopinavir/ritonavir
- Where
- Thailand
- Volunteers
- 24 people
- Sponsor
- The HIV Netherlands Australia Thailand Research Collaboration
Sepsis, Antibiotic Reaction
PK/PD of Ceftazidime Avitbatan Sodium in Children With Severe Infection
Ceftazidime avitbatan sodium is a broad-spectrum antibiotic with an antimicrobial spectrum covering resistant gram-negative bacteria. Its use in pediatric intensive care for severe infections is not unusual.
- Trial name
- NCT04961580
- Testing
- Ceftazidime Avitbatan Sodium
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Children's Hospital of Fudan University
Primary Immunodeficiency (PID)
Subcutaneous Ig NextGen 16% in PID Patients
This study aims to assess the safety, tolerability, efficacy and pharmacokinetics of Ig NextGen 16% in people with antibody deficiency currently being treated with IntragamP.
- Trial name
- NCT00391131
- Testing
- IgNextGen 16%
- Where
- 12 sites in Australia, New Zealand
- Volunteers
- 35 people
- Sponsor
- CSL Limited
HIV Infections
Lopinavir/Ritonavir Monotherapy in Children
The purpose of this study is to evaluate the efficacy (clinical, immunological, virological outcome), pharmacokinetics and safety of lopinavir/ritonavir (LPV/r) monotherapy maintenance in Thai children after viral load…
- Trial name
- NCT00626301
- Testing
- LPV/r
- Where
- 3 sites in Thailand
- Volunteers
- 40 people
- Sponsor
- The HIV Netherlands Australia Thailand Research Collaboration
Kidney Neoplasms, Neoplasm Metastasis
A Phase I Study of Continuous Intravenous Infusion of PSC 833 and Vinblastine in Patients With Metastatic Renal Cancer
Bolus PSC 833 is administered on Day 1 simultaneously with initiation of 24 hour continuous infusion of PSC 833, followed by another continuous infusion lasting an additional 6 days.
- Trial name
- NCT00001570
- Testing
- PSC 833, vinblastine
- Where
- United States
- Volunteers
- 46 people
- Sponsor
- National Cancer Institute (NCI)
Myelodysplastic Syndrome, Leukemia, Myelomonocytic, Juvenile
Study With Azacitidine in Pediatric Subjects With Newly Diagnosed Advanced Myelodysplastic Syndrome (MDS) and Juvenile Myelomonocytic Leukemia (JMML)
Indication Treatment of pediatric subjects with newly diagnosed advanced myelodysplastic syndrome (MDS) or juvenile myelomonocytic leukemia (JMML) prior to hematopoietic stem cell transplantation (HSCT).
- Trial name
- NCT02447666
- Testing
- Azacitidine
- Where
- 39 sites in Austria, Belgium and 11 more
- Volunteers
- 28 people
- Sponsor
- Celgene
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