Clinical Trials Logo

Pharmacodynamics clinical trials

View clinical trials related to Pharmacodynamics.

Filter by:

NCT ID: NCT06469450 Recruiting - Pharmacodynamics Clinical Trials

KF2023#1-Trial: Influence of Statin Intake on Cellular Readouts

Start date: April 20, 2024
Phase: Phase 1
Study type: Interventional

A majority of high-risk patients does not achieve their cholesterol target levels and most of these patients do not receive more effective combination therapy, which goes beyond statin monotherapy. Large interindividual differences in treatment outcomes have been observed for patients receiving statins. Statins block cholesterol synthesis and increase cellular low-density lipoprotein (LDL) uptake. Importantly, LDL uptake is highly divergent in individuals.The aim of this trial is to investigate how atorvastatin influences leukocyte readouts of LDL uptake and lipid storage in humans. The trial is a single-arm, open-label, interventional trial. A total of 15 healthy volunteers will receive 40 mg atorvastatin once a day for 4 weeks. The participants will provide blood samples before starting the atorvastatin intervention, each week when taking atorvastatin, and one week after the end of the intervention for the measurement of leukocyte readouts of LDL uptake and lipid storage.

NCT ID: NCT06072170 Completed - Pharmacokinetics Clinical Trials

Single Ascending Doses of Kratom in Healthy Nondependent Adults With Opioid Experience

Start date: September 12, 2023
Phase: Phase 1
Study type: Interventional

Kratom (Mitragyna speciosa) is a plant often used to self-treat conditions such as pain, coughing, diarrhea, anxiety and depression, opioid use disorder, and opioid withdrawal. Due to limited data availability, the goal of this clinical trial is to learn about safety, pharmacokinetics (what the body does to the drug) and pharmacodynamics (what the drug does to the body) of Kratom in adult recreational polydrug users with opioid experience.

NCT ID: NCT05795192 Completed - Pharmacokinetics Clinical Trials

SB17170 Phase1 Trial in Healthy Volunteer

Start date: May 24, 2023
Phase: Phase 1
Study type: Interventional

This clinical trial aims to learn about the safety, tolerability, and pharmacokinetic properties of SB17170 and its active metabolite SB1703 in single and multiple oral administration in healthy adults. The main questions it aims to answer are the safety, tolerability, and PK characteristics of SB17170 in healthy adults.

NCT ID: NCT05764356 Not yet recruiting - Bleeding Clinical Trials

Imapct of bioMarkers on Pharmacodynamics and Bleeding Risk of Direct Oral AntiCoagulants and Ticagrelor Study II

Start date: March 2023
Phase:
Study type: Observational

Individual differences in drug efficacy and adverse reactions are common in the clinical application of drugs. Individual differences are caused by many factors, among which genetic factors account for more than 20%. Novel oral anticoagulant drugs (NOACs, including rivaroxaban, apixaban, edoxaban, dabigatran, etc.) and novel antiplatelet drug ticagrelor have the advantages of convenient use and no need for monitoring. But novel oral antithrombotic drugs also increase the risk of bleeding, and there is currently a lack of effective antagonists when antithrombosis is excessive or emergency surgery is required. At present, there are few studies on the causes of individual differences in novel antithrombotic drugs, and there is a lack of predictable biomarkers or drug genotypes, especially in China. Therefore, on the basis of previous studies on NOACs and ticagrelor individualized medication cohorts, this study plans to establish a validation cohort for novel antithrombotic drugs bleeding related biomarkers, conduct multi-omics testing and long-term follow-up, and explore markers related to pharmacodynamics of antithrombotic drugs, adverse bleeding reactions and clinical outcomes.

NCT ID: NCT05716854 Completed - Pharmacokinetics Clinical Trials

Electrophysiological Effects of Potential QT Prolonging Drugs

Start date: March 21, 2023
Phase: Phase 1
Study type: Interventional

Since 2005, FDA has required almost all new drugs be tested for their ability to prolong the QT interval through clinical studies. This requirement stems from the increased TdP risk QT interval prolongation can cause. However, the QT interval is an imperfect biomarker, as there are multiple drugs that can prolong the QT interval, without causing increased TdP occurrence. As such, numerous drugs labeled as causing QT prolongation, may in fact have no impact on TdP occurrence. To address this problem, FDA, in collaboration with multiple external partners, has led an initiative to combine novel preclinical in vitro experiments within silico modeling and simulation followed by pharmacodynamic electrocardiographic (ECG) biomarkers. The goal is to use these novel computational and analytical tools to better predict TdP risk (beyond just the QT interval) by focusing on understanding the underlying mechanisms and applying an integrated biological systems approach. This clinical study consists of 2 parts: a 3-arm, 22-subject crossover study (Part 1) and a 4-arm, 22-subject crossover study (Part 2). These parts are included in the same protocol and study due to the similarity of the inclusion and exclusion criteria, similar procedures, and similar primary goals.

NCT ID: NCT05652595 Recruiting - Pharmacokinetics Clinical Trials

Double-blind, Randomized Comparative Cross-sectional Study of Pharmacodynamics and Pharmacokinetics of Drugs GP40141

Start date: June 3, 2022
Phase: Phase 1
Study type: Interventional

Bioequivalence Study of GP40141 (GEROPHARM) versus Enplate®. The study of comparative pharmacodynamics, pharmacokinetics and safety of drugs containing romiplostim in healthy volunteers after a single subcutaneous injection.

NCT ID: NCT05539872 Completed - Pharmacokinetics Clinical Trials

Comparison of the Pharmacokinetics (PK) and Pharmacodynamics (PD) Biosimilarity of Proposed Biosimilar Rapid-Acting Insulin Aspart (I004) and NovoLog After Single-Dose Subcutaneous Administration to Healthy Volunteers

Start date: August 22, 2022
Phase: Phase 2/Phase 3
Study type: Interventional

This study is a randomized, double-blinded, two-treatment, two-period, two-sequence crossover pivotal Biosimilar study. The purpose of this study is to establish pharmacokinetic (PK) and pharmacodynamics (PD) biosimilarity of proposed biosimilar I004 and the US-approved NovoLog.

NCT ID: NCT05153837 Recruiting - Clinical trials for Fluid Responsiveness

Effect of Oral Water in Healthy Volunteers on Cardiac Output, Regional Flow and Microcirculation in Healthy Volunteers

WATERNAL
Start date: November 30, 2021
Phase: N/A
Study type: Interventional

Human digestive system physiologically ensures the absorption of oral water and hydration of the human body. Water is quickly absorbed by the digestive tract with a peak between 15 and 20 minutes. It has demonstrated that oral water remains the best hydration solution that have an effect on plasma volume expansion and cardiovascular system during exercise. While the cardiovascular effect of fluid expansion by saline serum is well known (venous return, preload and cardiac output), effect of oral water varies in the literature depending on the physiological state of the patient and the clinical state. Thus, the investigators aim to investigate oral water effects on fluid responsiveness, regional blood flow and microcirculatory changes.

NCT ID: NCT05005520 Completed - Healthy Volunteers Clinical Trials

Study of DTRI-031 in Healthy Volunteers

Start date: October 20, 2021
Phase: Phase 1
Study type: Interventional

A randomized, double-blind, single center, placebo-controlled phase 1 study in healthy volunteers to assess safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of a single intravenous (iv) injection of DTRI-031

NCT ID: NCT04911270 Active, not recruiting - Pharmacokinetics Clinical Trials

Clinical Decision Support Tool for Vancomycin Dosing in Children

Start date: May 9, 2022
Phase: N/A
Study type: Interventional

This study will evaluate the pharmacokinetic and pharmacodynamic dosing properties of intravenous vancomycin in pediatric patients using a novel computer decision support (CDS) tool called Lyv. Dosing will be individualized based on AUC24/MIC. The results will be compared to matched historical controls.