First-in-Human Study of GRT7041 to Evaluate Safety, Tolerability, and How the Drug Works in Healthy Adults Includes Single and Multiple Dosing in Males and Women Not Able to Bear Children

What this Trial Is About

Researchers are evaluating the safety, tolerability, pharmacokinetics how the drug moves through the body, and pharmacodynamics the drugs effects on the body of GRT7041 in healthy adult men and women who are not capable of childbearing. This Phase 1 trial aims to better understand how GRT7041 behaves in the body and its safety profile. The study is sponsored by Grnenthal GmbH and includes healthy volunteers aged 18 to 60 years. The trial has two parts. Part 1 involves single ascending doses SAD of GRT7041 in up to five groups, including adult males and women of non-childbearing potential, with dosing mainly under fasting conditions except for one group assessing the effect of food on drug absorption. Part 2 involves multiple ascending doses MAD given once daily for 14 days to adult males only, also under fasting conditions. The study also examines how GRT7041 interacts with another drug called midazolam in Part 2. Participants will undergo a screening visit, stay in the study facility during treatment periods, and attend follow-up or end-of-trial visits. Researchers will monitor adverse events, conduct physical exams, ECGs, vital signs, laboratory tests, and measure drug levels in the blood over time. The total duration for participants is up to approximately 6 to 8 weeks for Part 1 and up to 7 weeks for Part 2, including treatment and observation periods to evaluate safety and drug behavior in the body.

A First-in-human Trial of GRT7041 in Healthy Participants