Clinical trials: Drug Kinetics
Healthy, HIV
A Study of the Safety, Pharmacokinetics and Antiretroviral Activity of 10-1074
This is a phase 1 clinical trial to evaluate the safety, pharmacokinetics and the antiretroviral effects of the highly neutralizing anti-HIV-1 monoclonal antibody 10-1074 in HIV-infected and HIV-uninfected individuals.
- Trial name
- NCT02511990
- Testing
- 3 mg/kg, single dose IV administration of 10-1074, 10 mg/kg, single dose IV administration of 10-1074, 30 mg/kg, single dose IV administration of 10-1074
- Where
- 2 sites in United States, Germany
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- Rockefeller University
Advanced Solid Tumors
Safety, Dose Tolerance, Pharmacokinetics, and Pharmacodynamics Study of CPX-POM in Patients With Advanced Solid Tumors
This is a first-in-human, Phase I, multicenter, open label, dose escalation study to evaluate the DLTs and MTD and to determine the recommended Phase 2 dose (RP2D) of CPX-POM administered IV in patients with any histologically…
- Trial name
- NCT03348514
- Testing
- CPX-POM - 30 mg/m^2, CPX-POM - 60 mg/m^2, CPX-POM - 120 mg/m^2
- Where
- 5 sites in United States
- Volunteers
- 19 people
- Sponsor
- CicloMed LLC
Respiratory Syncytial Virus (RSV)
Safety, Pharmacokinetics, and Antiviral Activity of Remdesivir (VEKLURY®) in Hospitalized Children With RSV
THAI-CARES RSV Study is a Phase II, open-label, multicenter, randomized controlled trial with a two-arm, parallel-group design. The study aims to assess the safety, efficacy, and acceptability of a five-day course of Remdesivir…
- Trial name
- THAI-CARES RSV (NCT06873633)
- Testing
- Remdesivir
- Where
- 8 sites in Thailand
- Volunteers
- 120 people
- Sponsor
- PENTA Foundation
Nontuberculous Mycobacterial Diseases
PK and PD of Drugs for Nontuberculous Mycobacterial Diseases in Dutch Patients
A prospective observational study in which pharmacokinetic and pharmacodynamic parameters are evaluated in a cohort of patients with NTM diseases.
- Trial name
- NTM (NCT01051752)
- Where
- 2 sites in Netherlands
- Volunteers
- 26 people
- Sponsor
- Radboud University Medical Center
Type 2 Diabetes Mellitus
Drug-drug Interaction Study of Dapagliflozin With Voglibose in Japanese Type 2 Diabetes Mellitus Patients
The purpose of this study is to evaluate the pharmacokinetics of dapagliflozin when administered alone or in combination with voglibose in Japanese patients with type 2 diabetes by assessment of AUC and Cmax of dapagliflozin
- Trial name
- NCT01055652
- Testing
- Dapagliflozin
- Where
- 2 sites in Japan
- Volunteers
- 28 people
- Sponsor
- AstraZeneca
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
Psoriasis
A First in Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Intravenous (IV) Dose of GSK2831781 in Healthy Volunteers and Patients With Plaque Psoriasis
This study is a phase I, randomised, double blind (sponsor unblinded), placebo-controlled, single ascending dose study GSK2831781 administered by IV.
- Trial name
- NCT02195349
- Testing
- GSK2831781
- Where
- 3 sites in Germany, United Kingdom
- Volunteers
- 67 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Neoplasms
A Dose-Escalation Study of RO5126766 in Patients With Advanced Solid Tumors.
This study will determine the maximum tolerated dose and the dose limiting toxicities (Part 1 of study) and the activity (Part 2 of study) of RO5126766 in patients with metastatic or advanced solid tumors.
- Trial name
- NCT00773526
- Testing
- RO5126766
- Where
- 3 sites in France, Spain and 1 more
- Volunteers
- 52 people
- Sponsor
- Hoffmann-La Roche
Obesity
A Study to Assess Safety, Tolerability, and Pharmacokinetics of MEDI0382 in Non-diabetic Obese Participants
This is a Phase 1, randomized, blinded, placebo-controlled study in up to approximately 51 non-diabetic obese participants with a body mass index (BMI) ≥ 35 kg/m^2.
- Trial name
- NCT03625778
- Testing
- MEDI0382
- Where
- 2 sites in United States
- Volunteers
- 51 people
- Sponsor
- MedImmune LLC
Hereditary Angioedema Types I and II
A Study to Evaluate the Safety and Pharmacokinetics of Two Formulations of C1-esterase Inhibitor
A new formulation of Berinert (CSL830) is being investigated for the management of hereditary angioedema (HAE). The main aim of the study is to assess the safety of a single 1500 IU dose of the new formulation of Berinert.
- Trial name
- NCT01760343
- Testing
- Berinert, CSL830
- Where
- Germany
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- CSL Behring
Pharmacokinetics of Ciprofloxacin in Neonates
TINN Pharmacokinetics (PK) Study Treat Infections iN Neonates
Phase I, open-label study to evaluate the pharmacokinetics, tolerability and short-term safety of ciprofloxacin in neonates with suspected (or proven) Gram Negative infection.
- Trial name
- TINN-PK (NCT01319435)
- Testing
- Collection of biological samples
- Where
- 2 sites in United Kingdom
- Volunteers
- 63 people
- Sponsor
- Liverpool Women's NHS Foundation Trust
Lung Injury, Acute
The Safety, Tolerability, PK and PD of GSK2586881 in Patients With Acute Lung Injury
This is an early phase (phase IIa), randomized, multi-center study in subjects with acute lung injury (ALI) or acute respiratory distress syndrome (ARDS).
- Trial name
- NCT01597635
- Testing
- Dose 1 GSK2586881, Dose 2 GSK2586881, Dose 3 GSK2586881
- Where
- 19 sites in United States, Canada
- Volunteers
- 44 people
- Sponsor
- GlaxoSmithKline
Glycogen Storage Disease Type II, Pompe Disease
A Study of the Safety and Pharmacokinetics of rhGAA in Siblings With Glycogen Storage Disease Type II
GSD-II (also known as Pompe disease) is caused by a deficiency of a critical enzyme in the body called acid alpha-glucosidase (GAA).
- Conditions
- Glycogen Storage Disease Type II, Pompe Disease, Acid Maltase Deficiency Disease, Glycogenosis 2
- Trial name
- NCT00051935
- Testing
- Alglucosidase alfa
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- Genzyme, a Sanofi Company
Refractory Cancer, Recurrent Cancer
A Study of RO7617991 in Patients With Locally Advanced or Metastatic MAGE-A4-Positive Solid Tumors
This study will evaluate the safety, tolerability, and pharmacokinetics of RO7617991, and will make a preliminary assessment of the anti-tumor activity of RO7617991 in human leukocyte antigen (HLA)-A*02 eligible patients with…
- Conditions
- Refractory Cancer, Recurrent Cancer, Solid Tumor, Adult
- Trial name
- NCT06372574
- Testing
- RO7617991, Tocilizumab
- Sponsor
- Genentech, Inc.
Healthy Subjects
Study Evaluation LXR-623 in Healthy Adults
To evaluate the safety and tolerability of multiple doses of LXR in healthy adults.
- Trial name
- NCT00379860
- Testing
- LXR-623
- Volunteers
- healthy volunteers welcome
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Uncomplicated Malaria
Pharmacokinetics of Dihydroartemisinin-Piperaquine in the Treatment of Uncomplicated Malaria in Children in Burkina Faso
This will be an open-label trial in Burkina Faso assessing the pharmacokinetics of the antimalarial combination of dihydroartemisinin/piperaquine (DP, Duocotexcin) in children.
- Trial name
- NCT00845533
- Testing
- Dihydroartemisinin-Piperaquine
- Sponsor
- University of California, San Francisco
Peanut Allergies
Study to Evaluate the Safety, Pharmacokinetic, and Pharmacodynamic Effects of MY006 in Healthy Volunteers and Patients With Peanut Allergy
The goal of this clinical trial is to evaluate the safety, pharmacokinetics, and effectiveness of MY006, a therapy designed to prevent severe or potentially life-threatening allergic reactions caused by accidental peanut intake.
- Trial name
- NCT07287033
- Testing
- MY006 Low Dose, MY006 Mid Dose, MY006 High Dose
- Where
- 9 sites in United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Mabylon AG
Respiratory Syncytial Virus Infections
A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of ALS-008176 in Healthy Japanese Adult Participants
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of ALS-008176 following oral administration of single ascending dose of ALS-008176 in healthy Japanese adult participants.
- Trial name
- NCT02478333
- Testing
- ALS-008176 (250 mg), ALS-008176 (500 mg), ALS-008176 (750 mg)
- Where
- Japan
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Janssen Pharmaceutical K.K.
Major Depressive Disorder
Efficacy, Safety and Pharmacokinetic Study of Inhaled Esketamine in Treatment-resistant Depression
The purpose of the study is to determine the efficacy, safety and pharmacokinetics of inhaled Esketamine in participants with treatment-resistant depression (TRD) in the course of Major Depressive Disorder (MDD).
- Trial name
- NCT03965858
- Testing
- Esketamine DPI - low dose, Esketamine DPI - medium dose, Esketamine DPI - high dose
- Where
- 12 sites in Poland
- Volunteers
- 88 people
- Sponsor
- Celon Pharma SA
Heartburn, Indigestion
A First-in-Human Study to Learn How Well a Bi-Layer Calcium Carbonate Antacid Tablet Works Compared to a Standard, Non-Layered Calcium Carbonate Tablet in Healthy Male Participants
Researchers are looking for a better way to treat people who have heartburn, indigestion, and problems due to excessive stomach acid. These are common problems which can affect daily life and disturb sleep during the night-time.
- Conditions
- Heartburn, Indigestion, Stomach Acid Related Symptoms, Nocturnal Stomach Acid Related Symptoms
- Trial name
- NCT06293326
- Testing
- bi-layer calcium carbonate tablet (BAY1180654), Immediate release calcium carbonate tablet (BAY1180654)
- Where
- United Kingdom
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- Bayer