Hepatitis A

Researchers are evaluating the safety, tolerability, and how the body processes pharmacokinetics two drugs, AZD9550 and AZD6234, in adults with different levels of liver impairment compared to those with normal liver function. This Phase I, open-label study includes participants with severe or moderate hepatic impairment as classified by the Child-Pugh score, as well as matched healthy controls. The goal is to understand how liver problems affect these drugs when given as single subcutaneous doses. Participants will receive separate single doses of AZD9550 and AZD6234 administered subcutaneously in two periods, with a washout period between the doses to reduce interference between drugs. The study groups include those with severe hepatic impairment Child-Pugh Class C, moderate hepatic impairment Child-Pugh Class B, and healthy individuals matched for sex, age, and body mass index. Approximately 16 participants with hepatic impairment and up to 12 healthy controls will be enrolled. During the study, participants will be assessed for drug levels in the body over 56 days after dosing to measure pharmacokinetic parameters such as AUCinf, AUClast, and Cmax. Safety and immune response will also be monitored through laboratory tests, vital signs, electrocardiograms, and adverse event reporting. The study duration includes screening, dosing periods, and follow-up visits to capture these outcomes under medical supervision.

Researchers are evaluating the protective efficacy and safety of a recombinant herpes zoster vaccine called LZ901 in healthy adults aged 40 years and older. This phase 3, randomized, double-blind, placebo-controlled trial aims to protect participants against shingles caused by the varicella zoster virus. The vaccine contains a tetramer of VZV glycoprotein E combined with an aluminum hydroxide adjuvant known to enhance immune response and widely used in vaccines worldwide. Participants will receive two doses of either the LZ901 vaccine or a placebo aluminum hydroxide adjuvant injected into the upper arm on day 0 and day 29. Around 26,000 participants will be enrolled, including a subgroup of about 3,000 to assess the consistency of immune response across three vaccine batches and monitor persistence of immunity up to 36 months. The study includes four groups treatment main, placebo main, treatment immunization, and placebo immunization groups. Participants will undergo up to 24 visits depending on their group, including on-site and in-person visits for screening, vaccination, and follow-up assessments. Researchers will monitor vaccine efficacy 30 days after full immunization, track adverse events from immediate to 12 months post-vaccination, and evaluate immune response through antibody tests at multiple time points. The study also explores the vaccines impact on reducing the severity and occurrence of postherpetic neuralgia in adults 40 years and older.

Researchers are investigating the use of 18F-DFA PET imaging to evaluate liver injury, a condition involving rapid liver function decline with symptoms like increased liver enzymes, jaundice, and abdominal discomfort. This observational study aims to assess how accurately this imaging method detects liver damage compared to standard clinical biochemical tests and liver biopsy, which is the current gold standard despite its sampling limitations. The study focuses on adults clinically diagnosed with liver damage or liver failure, exploring the correlation between 18F-DFA uptake in the liver and liver function indicators. Participants diagnosed with liver injury will undergo 18F-DFA PET imaging as part of the study. This radioactive tracer, based on vitamin C structure, is used to visualize liver function non-invasively. The imaging process involves a PET-CT scan lasting about 10 minutes, followed by a one-hour waiting period in the examination room before leaving. The study will compare imaging results with clinical liver function tests or liver biopsy findings to determine the sensitivity and specificity of this method. During the study, participants will have their liver function monitored using PET-CT scans and clinical biochemical markers. The primary outcomes include changes in liver uptake values on PET imaging at 6 months and the relationship between imaging results and standard liver function indicators. Participants will be followed up as needed, with assessments including liver enzyme levels and other blood tests. The total study duration depends on individual follow-up, and safety monitoring will address any issues related to PET imaging procedures.

Researchers are evaluating the effectiveness of low volume Transanal Irrigation TAI using the Qufora IrriSedo MiniGo device combined with standard conservative treatments compared to conservative treatment alone for patients with Low Anterior Resection Syndrome LARS. This condition affects individuals who have undergone surgery for rectal cancer. The study aims to assess improvements in clinical symptoms of LARS over a three-month period. Participants are divided into two groups one receiving low volume TAI with the MiniGo device plus standard conservative care, which includes dietary management, counseling, and prescribed medications excluding suppositories and physiotherapy and another group receiving only the standard conservative treatments. The study includes follow-ups at 6 weeks, 3 months, and up to 12 months to monitor various outcomes. During the study, participants will be regularly assessed using the LARS score to measure symptom changes, quality of life questionnaires EORTC QLQ-C30 and QLQ-CR29, incontinence scores, patient satisfaction, treatment compliance, bowel management time, and healthcare resource usage. Data will be collected at multiple intervals including 6 weeks, 3 months, 6 months, 9 months, and 12 months to thoroughly evaluate the treatment impact and patient preferences.

Researchers are evaluating the effect of liver function impairment on how the drug HDM1002 behaves in the blood. The study focuses on adults aged 18 to 70, including those with normal liver function and varying degrees of liver impairment. This Phase 1 trial aims to understand the drugs pharmacokinetics, safety, and tolerability in these different groups. Participants receive a single dose of HDM1002 on the first day of the study. The study includes separate groups for people without hepatic impairment and those with mild, moderate, or severe hepatic impairment. Researchers compare how the drug is processed in the body across these groups. During the trial, blood samples will be collected at multiple time points up to 72 hours after dosing to measure drug concentration and binding in plasma. Safety and tolerability are monitored throughout. The study is randomized and open-label, with participation lasting through the sampling period. The trial is sponsored by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

Researchers are studying how quickly the drug RAY1225 enters and leaves the bloodstream in adults with mild to moderate liver problems compared to those with healthy liver function. This phase 1 trial focuses on understanding the drugs behavior in participants with impaired liver function to gather basic scientific information. Participants are divided into three groups those with mild liver impairment, moderate liver impairment, and normal liver function. Each participant receives a single subcutaneous dose of 3 milligrams of RAY1225. The study measures how the drug is absorbed and processed over a period from day 1 to day 43. Throughout the study, participants undergo various assessments including blood tests to measure drug concentration and monitor for any adverse effects related to the drug. The main outcomes include the area under the drug concentration-time curve and the maximum drug concentration observed. Safety is also tracked by recording any drug-related side effects during the 43-day period. The total participation duration spans approximately six weeks.

Researchers are evaluating the pharmacokinetics and safety of the drug BMS-986435 in adults with normal liver function and those with mild or moderate liver impairment. The study aims to understand how the drug behaves in the body and its safety profile across these different liver function groups. This is a Phase 1, open-label study involving healthy volunteers and participants with hepatic impairment. Participants receive a single specified dose of BMS-986435. The study includes three groups those with mild hepatic impairment, moderate hepatic impairment, and matched participants with normal liver function. The study uses a parallel design and is non-randomized, with no blinding. During the study, participants will undergo assessments up to 45 days after dosing to measure drug concentration levels, including maximum concentration and the area under the concentration-time curve. Safety is monitored by recording adverse events and serious adverse events. Additional measures include drug half-life, time of maximum concentration, clearance, and volume of distribution. Participants must meet specific health criteria including adequate heart and kidney function. The total participation duration extends through these evaluation periods.

Researchers are evaluating how moderate or severe liver impairment affects the levels of inavolisib, a drug given as a single oral dose, in the body. The study focuses on participants with different degrees of hepatic impairment compared to healthy individuals with normal liver function. This phase 1 open-label study aims to understand the drugs pharmacokinetics, safety, and tolerability in these groups. Participants are divided into three groups based on their liver function healthy participants with normal hepatic function, those with moderate hepatic impairment, and those with severe hepatic impairment. Each participant receives one single oral dose of inavolisib on Day 1. The study uses a parallel design where each group is studied separately but concurrently. During the study, participants will have blood samples taken at multiple time points up to 96 hours after dosing to measure drug concentrations and pharmacokinetic parameters such as maximum concentration and area under the curve. Safety is monitored through reported adverse events up to Day 8. The total participation duration includes dosing and follow-up assessments to evaluate the drugs behavior and safety in participants with varying liver function.

Researchers are studying the effects of different levels of liver impairment on how the body processes treprostinil palmitil and treprostinil after a single dose of 80 micrograms of Treprostinil Palmitil Inhalation Powder TPIP. This Phase 1 trial aims to compare people with normal liver function to those with mild, moderate, or severe hepatic impairment to understand the drugs pharmacokinetics. Participants are divided into four groups based on liver function normal, mild, moderate, and severe impairment. Each participant receives one dose of TPIP by oral inhalation using a dry powder inhaler device on Day 1. The study monitors drug levels and safety after this single dose, with no placebo or randomization involved. During the study, participants undergo blood sampling at multiple timepoints up to three days after dosing to measure drug concentration and metabolism. Researchers also track adverse events up to seven days after dosing. Participants are assessed for eligibility with health evaluations and laboratory tests before receiving the dose. The total participation time includes screening, dosing, and follow-up assessments.

Researchers are studying how decreased liver function affects the way the body processes the medicine PF-07328948. The study involves adults aged 18 to 75 years with varying degrees of liver function, including healthy individuals and those with mild, moderate, or severe liver impairment. The goal is to understand if liver function changes the processing of this medicine in the body. Participants will receive a single oral dose of PF-07328948 tablet at the study clinic. Four groups are studied in parallel one with no liver impairment, and three with mild, moderate, or severe hepatic impairment. After taking the dose, participants will stay at the clinic for about six days for monitoring and testing. During the clinic stay, the study team will observe participants for treatment experience and collect blood samples at multiple time points to measure levels of PF-07328948. This helps assess how the liver function affects drug levels. Safety will be evaluated through adverse event monitoring up to 36 days. The total study duration includes dosing and follow-up assessments to understand the medicines behavior and tolerability.