Clinical Research Directory

Pharmacokinetic Study of Long-acting Antiretrovirals and Contraceptives in HIV

This study is being done to understand how long-acting injectable cabotegravir (CAB-LA) used for HIV pre-exposure prophylaxis (PrEP) and hormonal contraceptive methods affect each other when used at the same time. Women who are already using CAB-LA or not using PrEP will choose to join one of several groups based on whether they use injectable contraceptive (IM DMPA), an etonogestrel implant, or no hormonal contraceptive. Participants will have study visits every 4 to 12 weeks for up to 12 or 24 weeks after starting a contraceptive method to collect blood samples and measure levels of CAB-LA and hormone concentrations. The study will compare these levels to see if taking CAB-LA changes hormone concentrations or if using hormonal contraception changes CAB-LA drug levels. Safety, side effects, satisfaction, and continuation of CAB-LA PrEP and contraceptive methods will also be evaluated.

A Study to Learn About How Safe BAY3389934 is and How it Affects Blood Clotting When Given Alone or With Aspirin in Healthy Participants

The study treatment BAY3389934 is under development for people with blood clotting problems that occur due to sepsis. Sepsis is a serious condition that happens when the body's reaction to an infection causes organ damage. It can eventually lead to tiny blood clots formation throughout the body. BAY3389934 aims to work by blocking two important blood clotting proteins, called Factor IIa (thrombin) and Factor Xa, both of which help in blood clotting. By blocking them, BAY3389934 may slow down or stop excessive clotting. Aspirin is a drug that prevents platelets from clumping together. People with sepsis are often given aspirin for underlying heart-related problems. Since aspirin and BAY3389934 both affect how the blood clots, each in a different way, it is important to check whether using them together is safe and whether they change each other's effects on blood clotting. The main purpose of this study is to find out how safe BAY3389934 is when given together with aspirin and to see how the two affect blood clotting in healthy participants. To do this, the researchers will assess the number and severity of medical problems in healthy adult participants after receiving BAY3389934 alone and in combination with aspirin and compare them with the medical problems when participants received either drug alone. These medical problems are also known as "adverse events". Doctors keep track of all medical problems that happen in studies, even if they do not think they are related to study treatments. All participants will receive a single dose of aspirin tablet prior to the study. Researchers will check their response to decide whether they can participate in the study. Eligible participants will then receive the following three treatments, each at different time and in a different order assigned randomly. Treatment A: • no treatment the day prior to receiving study treatment. • BAY3389934 as an infusion into a vein on Day 1. Treatment B: • a single high-dose aspirin tablet on the day prior to receiving study treatment. • a single-low dose aspirin tablet on Day 1. Treatment C: • a single high-dose aspirin tablet on the day prior to receiving study treatment. • a single low-dose aspirin tablet followed by BAY3389934 4 hours continuous infusion into a vein on Day 1. There will be a gap of 3 days after Treatment A, and 14 days after Treatments B and C, when participants will not be given any treatment. Each participant will be in the study for around 2 months with up to 6 visits to the study clinic. They will visit the study clinic: • twice, before the treatment starts •once, during each of the three treatment periods •once, at the end of the treatment During the study, the doctors and their study team will •check participants' health by performing tests such as blood and urine tests, measuring blood pressure, heart rate and checking heart health using an electrocardiogram (ECG). •ask the participants questions about how they are feeling and any adverse events they are having. In this study, the participants will not benefit from taking of BAY3389934. However, the study will provide information on how BAY3389934 may be helpful in people with blood clotting problems caused due to sepsis.

Pharmacokinetic Effect of Y-3 on Repaglinide，Warfarin and Omeprazole in Healthy Participants

The primary goal of this clinical trial is to evaluate the effect of Y-3 for injection on the pharmacokinetic profile of the sensitive finger substrates repaglinide tablets, warfarin sodium tablets, and omeprazole enteric-coated capsules for CYP2C8, CYP2C9, and CYP2C19 in Chinese healthy participants, to evaluate whether Y-3 for injection(40mg) will have clinical drug interactions with repaglinide tablets, warfarin sodium tablets and omeprazole enteric-coated capsules, so as to provide a reference for the drafting of Y-3 drug instructions for injection and a basis for the safe and rational use of the drug after marketing. The secondary goal of this clinical trial is to observe the effect of Y-3 for injection on the safety of repaglinide tablets, warfarin sodium tablets and omeprazole enteric-coated capsules. The main questions it aims to answer are: What the pharmacokinetic profiles of repaglinide tablets, warfarin sodium tablets, and omeprazole enteric-coated capsules when using Y-3 (40 mg) in healthy participants. If Y-3 for injection (40mg) will have clinical drug interactions with repaglinide tablets, warfarin sodium tablets and omeprazole enteric-coated capsules If Y-3 for injection (40mg) is safe in participants who using repaglinide tablets, warfarin sodium tablets, and omeprazole enteric-coated capsules. Researchers will see what the pharmacokinetic profiles and safety of repaglinide tablets, warfarin sodium tablets, and omeprazole enteric-coated capsules when using Y-3 (40 mg) in healthy participants. Participants will: Take repaglinide tablets, warfarin sodium tablets and omeprazole enteric-coated capsules without Y-3. Take repaglinide tablets, warfarin sodium tablets and omeprazole enteric-coated capsules during the use of Y-3. Answer questions regarding your medical history. Comply with the study procedures and requests. Complete all tests and collections of PK Sampling. Must not have any special dietary requirements and be able to consume the food (low-fat) provided by Tranquil Clinical Research during your 4-night stay. Must avoid excessive (\> 8 cups per day) caffeine consumption (i.e. coffee or tea) during your time in the study. Must not consume any food or beverage rich in grapefruit, papaya, or mango during your time in the study. Must not take any other medications, including traditional Chinese medicines and herbal medicines, during your time in the study. Must avoid sexual activity or use non-drug contraceptive measures (i.e. condoms) during your time in the study. Female participants must not become pregnant while in the study. Must not receive any vaccinations during your time in the study. Must not donate blood for purposes outside of study procedures during your time in the study. Must not drink alcohol during your time in the study. Must not smoke during your time in the study. Inform your Study Doctor if you no longer wish to participate in the study.

Kuwa Free! - Live Free!

The study investigators are conducting foundational pharmacokinetic (PK) and qualitative studies, among 15-24 years old (inclusive) adolescent girls and young women living with HIV (AGYWLHIV) already on oral antiretroviral therapy (ART) and virally suppressed, leading up to a hybrid type I effectiveness-implementation trial randomizing individual AGYWLHIV to receive long-acting (LA) injectable cabotegravir/rilpivirine vs. standard of care within one of Kenya's largest HIV treatment programs. The PK and qualitative studies will investigate potential issues arising from co-delivery and guide delivery of the effectiveness-implementation trial. The PK and qualitative studies will largely be conducted with a sentinel cohort of AGYWLHIV. Learning from this early LA ART use, the investigators will refine the procedures in the LA ART hybrid trial.

Pharmaco-proteomic Platform to Evaluate Drug Interactions in Liver Transplant Patients

The goal of this observational study is to enhance the ability to forecast kidney failure in liver transplant patients in the ICU under multidrug treatment by developing a computer platform that integrates mathematical models of drug interactions, proteomics, and clinical data. The main outcomes it aims to develop are: 1. Design the multidrug web computing platform with available information on drug pair interactions (DDIs). 2. Integrate the proteomic and clinical data of liver transplant patients into the IT platform. 3. Implement the multidrug web platform to predict the clinical evolution of liver transplant patients.

Drug-drug Interactions With Anti-tuberculous Drugs

This study aims to assess the prevalence and the outcome of prescribing drugs known to have major drug-drug interactions with anti-tuberculous drugs among Kasr Alainy tuberculous patients.