In short
Clinical trials are investigating Iclepertin in people with schizophrenia and in healthy women. These studies look at long-term safety and whether Iclepertin changes the blood levels of a contraceptive. The trials include phase 1 and phase 3 research.
Key points
- Iclepertin is being studied in clinical trials for people with schizophrenia and in healthy women. One phase 3 extension study looked at long-term safety in patients who had already finished a previous CONNEX study. Another phase 1 study in healthy women tested whether Iclepertin changes the blood levels of a combined oral contraceptive. The trials were completed and included very different groups, from a large schizophrenia population to a small healthy volunteer group. The main outcomes were safety events in the schizophrenia study and blood exposure measures in the contraceptive study. Together, these trials focus on safety and drug interaction questions rather than symptom treatment.
Trial overview
The available trial data show two interventional studies of Iclepertin, one in people with schizophrenia and one in healthy women. Both studies were completed, and they looked at different research questions: long-term safety in patients and blood level changes of a contraceptive in healthy volunteers.
Schizophrenia extension study
The larger study was a phase 3 extension trial in people with schizophrenia. It enrolled 1,509 participants and was designed to collect extra safety data after people had already completed the 26-week treatment period in a previous CONNEX study program.
The study title and summary show that it focused on patients with cognitive impairment due to schizophrenia, which means problems with thinking, memory, or attention linked to the illness. The intervention listed was oral Iclepertin 10 mg.
The main endpoint was the occurrence of treatment-emergent adverse events (TEAEs) during the extension study. TEAEs are health problems that begin or get worse after the study treatment starts.
Healthy women study
The second study was a phase 1 trial in healthy women, with 16 participants. Its main goal was to see whether multiple oral doses of Iclepertin affect the steady-state blood levels of the combined oral contraceptive Microgynon, which contains ethinylestradiol and levonorgestrel.
This kind of study helps researchers check whether one treatment changes how another treatment appears in the blood. In simple terms, it asks whether taking Iclepertin changes the amount of contraceptive hormone in the body after repeated dosing.
Outcomes and endpoints
The schizophrenia extension study measured the number of TEAEs throughout the study period. This is a safety endpoint, meaning it helps researchers see what health problems happened during treatment.
The healthy women study measured pharmacokinetics, which is how much of a substance gets into the blood and how it changes over time. The specific outcomes were AUCτ,ss, Cmax,ss, and Cmin,ss for ethinylestradiol and levonorgestrel at steady state.
AUCτ,ss means total blood exposure over a dosing interval at steady state, Cmax,ss means the highest blood level, and Cmin,ss means the lowest blood level before the next dose.
Who could participate
In the phase 3 extension study, participation was limited to people with schizophrenia who had already taken part in and completed the earlier 26-week CONNEX treatment period. This makes the study an extension for people already known to the research program.
In the phase 1 study, the participants were healthy women. The trial title and summary do not describe a disease condition for this group because the goal was to study blood level effects in volunteers rather than treat an illness.
What the trials help answer
Together, these studies help answer two important research questions about Iclepertin: whether long-term use is safe in people with schizophrenia and whether it changes the blood levels of a contraceptive in healthy women.
The trial data do not describe symptom benefit, so these records are mainly about safety and interaction testing in specific study groups.