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Iclepertin

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.

Table of Contents

Trial overview

The available trial data show two interventional studies of Iclepertin, one in people with schizophrenia and one in healthy women.[1][2] 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.[1][2]

Schizophrenia extension study

The larger study was a phase 3 extension trial in people with schizophrenia.[1] 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.[1]

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.[1] The intervention listed was oral Iclepertin 10 mg.[1]

The main endpoint was the occurrence of treatment-emergent adverse events (TEAEs) during the extension study.[1] TEAEs are health problems that begin or get worse after the study treatment starts.[1]

Healthy women study

The second study was a phase 1 trial in healthy women, with 16 participants.[2] 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.[2]

This kind of study helps researchers check whether one treatment changes how another treatment appears in the blood.[2] In simple terms, it asks whether taking Iclepertin changes the amount of contraceptive hormone in the body after repeated dosing.[2]

Outcomes and endpoints

The schizophrenia extension study measured the number of TEAEs throughout the study period.[1] This is a safety endpoint, meaning it helps researchers see what health problems happened during treatment.[1]

The healthy women study measured pharmacokinetics, which is how much of a substance gets into the blood and how it changes over time.[2] The specific outcomes were AUCτ,ss, Cmax,ss, and Cmin,ss for ethinylestradiol and levonorgestrel at steady state.[2]

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.[2]

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.[1] This makes the study an extension for people already known to the research program.[1]

In the phase 1 study, the participants were healthy women.[2] 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.[2]

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.[1][2]

The trial data do not describe symptom benefit, so these records are mainly about safety and interaction testing in specific study groups.[1][2]

Trial ID Phase Condition studied Status Enrollment
2024-511560-93-00 Phase 3 Schizophrenia Completed 1509
2022-500050-42-00 Phase 1 Healthy Completed 16

FAQ

  • What are the Iclepertin trials studying? The trials are studying long-term safety in people with schizophrenia and possible effects on contraceptive blood levels in healthy women. They do not focus on treating symptoms in this summary.
  • Who can take part in the schizophrenia study? People with schizophrenia who already took part in and finished a previous 26-week CONNEX study could join the extension study. It was designed for patients with cognitive impairment due to schizophrenia.
  • Who can take part in the healthy women study? Healthy women were enrolled in the phase 1 study. The trial tested whether Iclepertin changes the blood levels of a combined oral contraceptive.
  • What phases were the Iclepertin trials? The data include a phase 1 study and a phase 3 study. Phase 1 usually checks early effects in a small group, while phase 3 studies are larger and often look at safety in a patient population.
  • What outcomes were measured? One study measured treatment-emergent adverse events, which are health problems that start or get worse after treatment begins. The other study measured blood exposure levels of ethinylestradiol and levonorgestrel, including AUC, Cmax, and Cmin.

Ongoing Clinical Trials on Iclepertin

  • Effect of iclepertin on the blood levels of ethinylestradiol and levonorgestrel in healthy premenopausal women

    Not recruiting

    1 1 1 1
    Investigated drugs:
    Germany

  • Study on Long-Term Safety of Iclepertin for Patients with Schizophrenia Who Completed Previous Trials

    Not recruiting

    3 1 1
    Investigated drugs:
    Austria Belgium Bulgaria Croatia Czechia Denmark +15

Glossary

  • Schizophrenia: A long-term mental health condition that can affect thinking, feelings, and behavior.
  • Cognitive impairment: Problems with memory, attention, or thinking skills.
  • Phase 1: An early clinical trial phase that usually studies a treatment in a small group.
  • Phase 3: A later trial phase that studies a treatment in a larger group of people.
  • Interventional study: A study where researchers give a treatment or intervention and then measure the results.
  • Treatment-emergent adverse events (TEAEs): Health problems that begin or become worse after a study treatment is started.
  • Pharmacokinetics: How a substance moves through the body, including how much gets into the blood.
  • AUC: A measure of total drug exposure in the blood over time.
  • Cmax: The highest measured level of a substance in the blood.
  • Cmin: The lowest measured level of a substance in the blood before the next dose.
  • Steady state: A point where the amount of a substance in the body stays fairly stable with regular dosing.
  • Combined oral contraceptive: A birth control pill that contains two hormones.

References

  1. https://clinicaltrials.gov/study/2024-511560-93-00
  2. https://clinicaltrials.gov/study/2022-500050-42-00