View clinical trials related to Pharmacokinetics.
Filter by:Non-interventional PK sub-study of QUILT-3.032 (CA-ALT-803-01-16) and QUILT-2.005 (CA-ALT-803-01-14)
This study will help provide information about how patients with burn handle two antibiotics (ceftolozane and tazobactam) and use that information to guide dosing recommendations for these patients. The 12 patients who complete the study will receive a single dose of 3 grams ceftolozane/tazobactam intravenously. We will collect blood and urine samples to determine how much of each antibiotic is in the body and urine at various times over a 24 hour period. This information will be used with previously published information from microbiology laboratories to perform simulations that will provide recommendations on optimal dosing recommendations of these antibiotics in patients with burns.
The purpose of this study is to evaluate the safety and tolerability of single and multiple oral dosing of MLN3126 in ascending doses in healthy non-Japanese and Japanese participants.
Background: - (11C)mGlu1 is a new drug that helps to show where a protein, mGluR1, is found in the brain. The drug contains a small amount of radioactivity that can be detected by imaging studies like positron emission tomography (PET) scans. By looking at the mGluR1 receptors, researchers hope to better understand how they are involved in general health, brain disorders, and addiction. Objectives: - To test how (11C)mGlu1 is distributed in the brain and body. - To measure how mGluR1 receptors display (11C)mGlu1 during imaging studies. Eligibility: - Healthy volunteers between 18 and 50 years of age. Design: - Participants will be screened with a medical history, physical exam, and blood and urine tests. This study requires four visits to the NIH Clinical Center. - Participants will have an initial evaluation, a magnetic resonance imaging (MRI) scan, a PET scan, and a final blood sample after the PET scan, all at different visits. - The MRI and PET scans will focus on the brain. Participants will receive (11C)mGlu1, and have scans to see how it shows up in the brain. - Some participants will have whole body imaging studies to see how (11C)mGlu1 shows up in the body.
First in man study with single and multiple rising doses with SLV342
1. To investigate the effect of kidney function on the elimination of a single dose of PD 0332334 from the body. 2. To investigate the safety and tolerability of a single dose of PD 0332334 in patients with impaired kidney function.
RhuDex® (code number AV1142742) is a novel, orally bioavailable, low molecular weight modulator of co-stimulation of T lymphocytes. RhuDex® binds to the protein CD80 (also known as B7-1) on the surface of antigen-presenting cells and inhibits its interaction with CD28 (but not with CTLA-4) presented by CD4+ T lymphocytes. RhuDex® is being developed for the treatment of rheumatoid arthritis. To improve oral bioavailability, the study drug has to be co-administered with an alkaline buffer that increases gastric pH values. In previous in vitro and phase I studies, meglumine has been identified as the most effective buffer. Study CT 5002 is designed to evaluate the bioavailability of four increasing doses of RhuDex®, combined with a fixed amount of meglumine using a tablet formulation, under fed and fasted conditions as well as with co-administration of the proton pump inhibitor pantoprazole. Furthermore, dose/plasma concentration proportionality for single dosing and accumulation effects for repeat dosing of RhuDex® will be evaluated.
The purpose of this study is to compare the blood levels of valproic acid in subjects with different body weights and to evaluate whether the pharmacokinetic parameters of this drug is altered in the obese population.