Clinical trials: Pharmacokinetic Study
- Condition Pharmacokinetic Study
- Funder type Industry (pharma, biotech, devices)
- Age group Children (under 18)
Rheumatoid Arthritis (RA)
Evaluation of Patient Performance Using the Metoject Device for Subcutaneous Injection in Rheumatoid Arthritis (RA)Patient
To evaluate the human factors/usability of Rheumatoid Arthritis (RA) patients with the Metoject® prefilled pen (including a label comprehension assessment and a device robustness evaluation).
- Trial name
- NCT01871961
- Testing
- Methotrexate (Metoject® prefilled pen)
- Where
- United States
- Volunteers
- 105 people
- Sponsor
- medac GmbH
Sickle Cell Disease, Sickle-Cell; Hemoglobin Disease, Thalassemia
Pharmacokinetics of Oral Hydroxyurea Solution
An open label, safety and pharmacokinetic study of oral hydroxyurea solution administered to children from 6 months to 17.99 years (i.e.
- Conditions
- Sickle Cell Disease, Sickle-Cell; Hemoglobin Disease, Thalassemia, Sickle Cell-beta-thalassemia, Sickle Cell Hemoglobin C
- Trial name
- HUPK (NCT03763656)
- Testing
- Oral Hydroxyurea (100 mg/mL) Solution
- Where
- 6 sites in Jamaica, United Kingdom
- Volunteers
- 33 people
- Sponsor
- Nova Laboratories Limited
Nausea and Vomiting Chemotherapy-Induced, Nausea Post Chemotherapy
Study With IV NEPA (Fosnetupitant/Palonosetron) for the Prevention of Chemotherapy-induced Nausea and Vomiting in Paediatric Cancer Patients Undergoing Highly Emetogenic Chemotherapy (HEC)
Chemotherapy often causes nausea and vomiting (CINV), and this is a major problem for the children being treated for cancer. To prevent this, a combination of two substances in fixed proportion (IV NEPA) was developed.
- Trial name
- NCT06904235
- Testing
- IV NEPA (fosnetupitant/palonosetron), Reference Treatment: IV ondansetron infusion, Reference Treatment: IV fosaprepitant infusion
- Where
- 20 sites in Greece, Poland and 2 more
- Volunteers
- 95 people
- Sponsor
- Helsinn Healthcare SA
Prostate Cancer, Hormone Refractory Prostate Cancer
A Phase 1 Study of MDV3100 in Patients With Castration-Resistant (Hormone-Refractory) Prostate Cancer
This is a multi-center open-label dose-escalation study of a novel compound (MDV3100) to treat patients with castration-resistant (hormone-refractory) prostate cancer.
- Trial name
- NCT00510718
- Testing
- MDV3100
- Where
- 9 sites in United States
- Volunteers
- 140 people
- Sponsor
- Pfizer
Gram Positive Infection, Concurrent Antibiotic Treatment
PK and Safety Evaluation of Daptomycin in Children Ages 2-6 With Proven or Suspected Gram-positive Infections
This is a research study designed to look at the pharmacokinetics (distribution, breakdown, and removal) and tolerability of a single dose of daptomycin in patients aged 2 to 6 years who have infections that are caused by a…
- Trial name
- NCT00679835
- Testing
- daptomycin
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Short Bowel Syndrome
Study of Teduglutide in Japanese Participants With Short Bowel Syndrome
The objectives of this clinical study are to evaluate the safety, efficacy, and pharmacokinetics (PK) of teduglutide in Japanese participants with short bowel syndrome (SBS) who are dependent on parenteral nutrition/intravenous…
- Trial name
- NCT03663582
- Testing
- Teduglutide, Syringe, Needle
- Where
- 5 sites in Japan
- Volunteers
- 7 people
- Sponsor
- Shire
Respiratory Syncytial Virus Infections
Study to Evaluate Safety and Antiviral Activity of Doses of JNJ-53718678 in Children (>=28 Days to <=3 Years) With Respiratory Syncytial Virus Infection
The purpose of this study is to evaluate the antiviral activity, clinical outcomes, safety, tolerability, and pharmacokinetic/pharmacodynamic relationships of different oral dose levels of JNJ-53718678 in children greater than or…
- Trial name
- NCT03656510
- Testing
- JNJ-53718678
- Where
- 169 sites in United States, Argentina and 20 more
- Volunteers
- 246 people
- Sponsor
- Janssen Research & Development, LLC
HIV Infections
A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of a New Formulation of Cabotegravir Long-Acting Administered Intramuscularly in a 4-month Dosing Interval (Q4M)
This study will evaluate the pharmacokinetics (PK), safety, and tolerability of a new formulation of Cabotegravir (CAB) dosed every 4-months (Q4M) for pre-exposure prophylaxis (PrEP) in participants at risk of HIV-1 acquisition.
- Trial name
- NCT06741397
- Testing
- CAB LA, New formulation of CAB LA
- Where
- 27 sites in United States, Puerto Rico
- Volunteers
- 229 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
Intubated and Mechanically Ventilated Pediatric Subjects
Pharmacokinetics and Pharmacodynamics of Dexmedetomidine in Pediatrics Subjects
The objective of this study is to characterize the pharmacokinetic and pharmacodynamic profile of dexmedetomidine administered as an intravenous loading dose followed by a continuous intravenous infusion in pediatric subjects…
- Trial name
- NCT00652028
- Testing
- Dexmedetomidine, midazolam; fentanyl
- Where
- 9 sites in United States, Guatemala
- Volunteers
- 69 people
- Sponsor
- Hospira, now a wholly owned subsidiary of Pfizer
Invasive Fungal Infections
Rezafungin Paediatric PK Study in Paediatric Subjects From Birth to <18 Years of Age
This study aimed to learn what levels of rezafungin were in the blood after dosing and how safe it was, in children and adolescents below 18 years old who were already receiving treatment for a fungal infection, a suspected…
- Trial name
- NCT05534529
- Testing
- Rezafungin Acetate
- Where
- 10 sites in Germany, Spain and 1 more
- Volunteers
- 32 people
- Sponsor
- Mundipharma Research Limited
Severe Hemophilia A
A Study of Repeat Dosing of PEG Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection
Primary objective: To assess the pharmacokinetics, Safety and immunogenicity of Repeat Dosing of PEG Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection With Severe Hemophilia A(FRSW117) Secondary…
- Trial name
- NCT05265286
- Testing
- FRSW117
- Where
- 5 sites in China
- Volunteers
- 15 people
- Sponsor
- Hangzhou Gensciences Biopharmaceutical Co., Ltd.
Anesthesia
Safety and Pharmacokinetics of Kovacaine Nasal Spray in Pediatric Subjects
The purpose of this study is to determine the pharmacokinetics and safety of a nasal spray containing the anesthetic drug Tetracaine in combination with Oxymetazoline in healthy pediatric subjects.
- Trial name
- NCT01952990
- Testing
- Tetracaine HCl 3% and Oxymetazoline HCl 0.05%
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- St. Renatus, LLC
Secondary Hyperparathyroidism
A Phase 3 Study of Etelcalcetide in Children With Secondary Hyperparathyroidism Receiving Hemodialysis
Assess the efficacy, safety, pharmacokinetics (PK) and pharmacodynamics (PD) of etelcalcetide in the treatment of secondary hyperparathyroidism (SHPT) in pediatric participants between ≥ 2 to < 18 years of age, with chronic…
- Trial name
- NCT03969329
- Testing
- Etelcalcetide
- Where
- 23 sites in Belgium, Czechia and 10 more
- Volunteers
- 24 people
- Sponsor
- Amgen
Cushing Syndrome
Pharmacokinetic (PK), Pharmacodynamic (PD) and Tolerability of Osilodrostat in Pediatric Patients With Cushing's Syndrome
Multicenter, open-label, non-comparative study to evaluate the pharmacokinetics, pharmacodynamics, and tolerability of osilodrostat in children and adolescent patients with Cushing's syndrome.
- Trial name
- NCT03708900
- Testing
- LCI699
- Where
- 15 sites in United States, Belgium and 5 more
- Volunteers
- 12 people
- Sponsor
- RECORDATI GROUP
Hereditary Angioedema
PK Subtrial in Adolescent Patients With HAE Type I or II Participating in the KVD900-302 Trial
This is a multicenter pharmacokinetic (PK) subtrial to investigate the PK profile of KVD900 (sebetralstat) in adolescent patients 12 to 17 years of age with Hereditary Angioedema (HAE) type I or II.
- Trial name
- NCT05511922
- Testing
- KVD900 600 mg, Drug: KVD900 300 mg
- Where
- 61 sites in United States, Australia and 15 more
- Volunteers
- 11 people
- Sponsor
- KalVista Pharmaceuticals, Ltd.
Atopic Dermatitis
Safety, Efficacy and Pharmacokinetic Study of Allegra in Pediatric Patients With Atopic Dermatitis (AD)
Primary Objective: To evaluate safety (4 weeks) Secondary Objectives: To evaluate the long-term safety (12 weeks) To evaluate the efficacy To characterize the pharmacokinetic profile
- Trial name
- NCT01244230
- Testing
- fexofenadine/Allegra (M016455)
- Where
- 13 sites in Japan
- Volunteers
- 100 people
- Sponsor
- Sanofi
Ewing's Sarcoma, Primitive Neuroectodermal Tumor (PNET)
Study of Zalypsis® (PM00104) in Patients With Unresectable Locally Advanced and/or Metastatic Ewing Family of Tumors (EFT) Progressing After at Least One Prior Line of Chemotherapy
This is a phase II Multicenter, Open-label, Clinical and Pharmacokinetic Study of Zalypsis® (PM00104) in Patients with Unresectable Locally Advanced and/or Metastatic Ewing Family of Tumors (EFT) Progressing After at Least One…
- Conditions
- Ewing's Sarcoma, Primitive Neuroectodermal Tumor (PNET), Askin's Tumor of the Chest Wall, Extraosseous Ewing's Sarcoma (EOE)
- Trial name
- NCT01222767
- Testing
- Zalypsis
- Where
- 7 sites in United States, France and 1 more
- Volunteers
- 17 people
- Sponsor
- PharmaMar
Primary Immunodeficiency Diseases (PID)
Efficacy, Safety and Pharmacokinetic of Virchow IVIG in PID Patients
The study duration for individual patients will be up to 55 weeks for the 4-weekly and 3- weekly schedule of the treatment which includes 3 weeks for screening, 48 weeks for Study Medication administration and 4 weeks for…
- Trial name
- VBPL-IVIGP3 (NCT07017036)
- Testing
- IVIG-VImmune, IVIG-Immuglo
- Where
- 2 sites in India
- Volunteers
- 44 people
- Sponsor
- Virchow Group
Attention Deficit Hyperactivity Disorder
Pharmacokinetic Study of DYANAVEL XR (Amphetamine) Extended-release Oral Suspension, in Children Aged 4 to 5 Years
The objective of this study was to evaluate the plasma amphetamine concentration/time profile of amphetamine extended release oral suspension in children aged 4 to 5 years with attention-deficit/hyperactivity disorder, following…
- Trial name
- NCT03610464
- Testing
- Amphetamine Extended Release Suspension [Dyanavel]
- Where
- United States
- Volunteers
- 5 people, healthy volunteers welcome
- Sponsor
- Tris Pharma, Inc.
Postoperative Pain, Acute Pain
Pharmacokinetic, Efficacy and Safety Study of Tapentadol Oral Solution in Children With Postoperative Pain
To find out if a drug called tapentadol administered by mouth safely relieves pain in children. Look at the amount of tapentadol in the blood after a single oral dose.
- Trial name
- NCT01729728
- Testing
- Tapentadol
- Where
- United States
- Volunteers
- 86 people
- Sponsor
- Grünenthal GmbH