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NCT07587008
Study to Assess Adverse Events and How Oral Emraclidine Moves Through the Body of Adult Healthy Volunteers
Conditions: Healthy Volunteers
Sex: All
Ages: 18 Years – 55 Years
Healthy volunteers: Yes
Phase: PHASE1
Enrollment: 12
Sponsor: AbbVie
Location: Acpru /Id# 283349 Grayslake Illinois
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.
Eligibility 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
Source: ClinicalTrials.gov (NCT07587008). StuddyBuddy aggregates publicly available trial information.