Study to Assess Adverse Events and How Oral Emraclidine Moves Through the Body of Adult Healthy Volunteers

Study Identifier
M26-506
CT.gov Identifier
NCT07587008
EudraCT Identifier
Not available
EUCTIS ID
Not available
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844-663-3742 or [email protected]

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Study Details

Medical Condition
  • Healthy Volunteer
    • Study Drug
  • Emraclidine
    • Phase
    Phase 1
    Sex
    Female & Male
    Age
    18 - 55 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Body mass index of 18.5 to 32.0 kg/m2, inclusive. * Total body weight \>= 50 kg.
    Exclusion Criteria:
    * History of suicidal ideation within one year prior to study treatment administration and/or history of suicidal behavior or non-suicidal self-injury within two years prior to study treatment administration as evidenced by any "yes" answer to questions on the Columbia-Suicide Severity Rating Scale (C-SSRS) at the screening visit or upon initial confinement. * Vital sign measurements, at Screening and Check-in: * Systolic blood pressure \>= 140 mmHg or \< 100 mmHg * Diastolic blood pressure \>= 90 mmHg or \< 60 mmHg * Heart rate \> 100 bpm or \< 50 bpm * Orthostatic hypotension, defined as a decrease of \>= 20 mmHg in systolic blood pressure upon standing compared with the supine/sitting blood pressure measurement. * Female participants of childbearing potential

    Protocol Summary

    The objective of this study is to evaluate the pharmacokinetics (PK) and relative bioavailability of emraclidine following single oral administration of different immediate-release (IR) tablet formulations in healthy adult participants.

    Study Locations

    No locations found.