Gieres

Researchers are conducting a Phase 1 study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of Leucettinib-21 in healthy volunteers as well as people with Down Syndrome and Alzheimer's Disease. The study is divided into six parts, including single and multiple ascending doses in healthy subjects, the effect of food on the drug's absorption, and single-dose evaluation in individuals with Down Syndrome or Alzheimer's Disease. The main goal is to assess how the drug behaves and its safety in these populations. The study includes different dosing schedules: Parts 1 and 5 involve single ascending doses, Parts 3 and 6 involve multiple ascending doses, and Part 2 evaluates the impact of a high-fat meal on drug absorption compared to fasting. Part 4 focuses on a single dose given to individuals with Down Syndrome or Alzheimer's Disease. Participants will receive oral administration of Leucettinib-21, and doses will increase in a stepwise manner for certain parts. Participants will attend multiple visits for safety and tolerability monitoring, including blood pressure, heart rate, ECGs, laboratory tests, and pharmacokinetic assessments. The study will track adverse events up to 21 days after dosing depending on the part. Secondary objectives include studying pharmacodynamic biomarkers. The total duration of follow-up ranges from up to 8 days for single doses to up to 21 days for multiple dose administrations.

Researchers are studying the pharmacokinetic (PK) and pharmacodynamic (PD) profiles of EYP651 at two different dose levels and comparing them to Vonafexor Acid. The study is divided into two parts: Part A focuses on comparing PK and PD profiles, while Part B evaluates potential drug-drug interactions with a high dose of EYP651. This is an open-label, Phase 1 trial involving healthy adult male and female volunteers aged 18 to 65 years. In Part A, participants receive repeated daily doses of either EYP651 or Vonafexor Acid for five days in a randomized, two-period cross-over design. Part B uses a three-period parallel-arm design where participants receive EYP651 alone and then in combination with different index drugs that affect CYP3A4, transporter substrates, and CYP2C8/CYP2C9 enzymes. The expected duration is about eight weeks for Part A and twelve weeks for Part B. Participants will undergo clinical assessments including medical history, physical exams, ECGs, and laboratory tests to confirm health status. Researchers will monitor drug levels in the body and measure effects on enzyme activity and drug interactions over one to five days. Safety and tolerability will be observed throughout the study. Total participation time varies by study part but includes multiple treatment periods and follow-up assessments.