Clinical trials: Pharmacokinetic
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
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
Hemophilia
Impact of Moderate Intensity Physical Activities on PK-guided EHL FVIII Concentrates Prophylaxis Severe HA Patients
To compare clinical outcomes before and after using combination between moderate to vigorous-intensity physical activities and pharmacokinetic-guided extended half-life FVIII concentrates prophylaxis in moderate to severe…
- Trial name
- NCT05728528
- Testing
- combination between moderate to vigorous-intensity physical activities and pharmacokinetic-guided extended half-life FVIII concentrates prophylaxis, pharmacokinetic-guided extended half-life FVIII concentrates prophylaxis alone
- Where
- Thailand
- Volunteers
- 13 people
- Sponsor
- Chulalongkorn University
Tuberculosis, HIV
Rifapentine and Isoniazid TB Preventive Therapy (3HP) for Children Taking Dolutegravir-based Antiretroviral Treatment (DOLPHIN KIDS)
Single-arm, multi-center, Phase I/II clinical trial, in two groups. Individuals with HIV infection taking Efavirenz (EFV), nevirapine (NVP) or lopinavir/ritonavir (LPV/r) and two nucleoside reverse transcriptase inhibitors (NRTI)…
- Trial name
- DOLPHIN KIDS (NCT05122767)
- Testing
- Dolutegravir, 3HP
- Where
- 2 sites in South Africa
- Volunteers
- 92 people
- Sponsor
- The Aurum Institute NPC
Graft vs Host Disease
GVH 022P: Study Using Anti Tumor Necrosis Factor Antibody (Infliximab) for Treatment of Acute Graft Versus Host Disease
Acute graft versus host disease (GVHD) remains one of the most significant and potentially lethal complications of allogeneic bone marrow transplantation.
- Trial name
- NCT00228839
- Testing
- Infliximab
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Emory University
Heart Disease
Pharmacokinetic Study of Dexmedetomidine After Intra-nasal Dosing in Children
This research study is examining the absorption of the sedative dexmedetomidine (DEX) in the blood when given by nasal spray. The study will help us determine the best dosing amount for children undergoing sedation or anesthesia…
- Trial name
- NCT02836431
- Testing
- Dexmedetomidine 1mcg/kg Intranasal, Dexmedetomidine 2mcg/kg Intranasal, Dexmedetomidine 1mcg Intravenous
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- Children's Hospital Medical Center, Cincinnati
HIV Infection
The Intensive Pharmacokinetics Sub-study of Encore1 (ENCORE1-PK)
Safety and efficacy are key issues in antiretroviral therapy (ART) selection. Efavirenz (EFV) is an important component of combination ART in treatment naive individuals.
- Trial name
- NCT01271894
- Testing
- Efavirenz
- Where
- 4 sites in Argentina, South Africa and 2 more
- Volunteers
- 40 people
- Sponsor
- Kirby Institute
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
Malignant Solid Tumour
Hydroxychloroquine + Vorinostat in Advanced Solid Tumors
This study is an open label non randomized study of hydroxychloroquine (HCQ) with histone deacetylase (HDAC) inhibitor Vorinostat in patients with advanced solid tumors to determine the maximum tolerated dose (MTD) and to…
- Trial name
- NCT01023737
- Testing
- Hydroxychloroquine, Vorinostat
- Where
- United States
- Volunteers
- 72 people
- Sponsor
- The University of Texas Health Science Center at San Antonio
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)
Respiratory Syncytial Virus (RSV)
Peginterferon α-2b Injection for Aerosol Therapy in Pediatric Respiratory Syncytial Virus Pneumonia
This is a multicenter, randomized, open-label, parallel-controlled, prospective clinical study. It aims to evaluate the efficacy and safety of aerosolized Peginterferon α-2b injection in the treatment of pediatric respiratory…
- Trial name
- NCT06881056
- Testing
- Peginterferon α-2b injection, symptomatic and supportive treatment
- Where
- 2 sites in China
- Volunteers
- 90 people
- Sponsor
- West China Second University Hospital
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
Solid Tumors
rhEndostatin Protein Involving Pediatric Patients With Cancer
The purpose of this study is to assess the safety of rhEndostatin, to determine how much of the drug stays in the patients blood (pharmacokinetics), to assess the development of proteins in the blood that are produced by the body…
- Trial name
- NCT00165373
- Testing
- rhEndostatin
- Where
- United States
- Volunteers
- 21 people
- Sponsor
- Dana-Farber Cancer Institute
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
Acute Myeloid Leukemia
Crenolanib in Combination With Sorafenib in Patients With Refractory or Relapsed Hematologic Malignancies
PRIMARY OBJECTIVE: This is a pilot study to characterize the toxicity profile, to determine the maximum tolerated dose of the combination of crenolanib and sorafenib, and to determine the feasibility of administering these drugs…
- Trial name
- NCT02270788
- Testing
- Crenolanib, Sorafenib, methotrexate, hydrocortisone and cytarabine with leucovorin
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- St. Jude Children's Research Hospital
Infant, Newborn, Infant, Low Birth Weight
Multi-dose Pharmacokinetics and Dose Ranging of Inositol in Premature Infants (INS-2)
This pilot study is a randomized, placebo-controlled, clinical trial to measure changes in blood and urine levels of inositol in premature infants at high risk for retinopathy of prematurity (ROP) following repeated doses of…
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Trial name
- INS-2 (NCT01030575)
- Testing
- Inositol lower volume, Inositol mid-level volume, Inositol high volume
- Where
- 17 sites in United States
- Volunteers
- 125 people, healthy volunteers welcome
- Sponsor
- NICHD Neonatal Research Network