RecruitingPhase 1NCT07587008
Study to Assess Adverse Events and How Oral Emraclidine Moves Through the Body of Adult Healthy Volunteers
A Phase 1, Open-label, Single Dose, Crossover Study to Assess the Relative Bioavailability of Emraclidine Formulations in Healthy Adult Subjects
Sponsor
AbbVie
Enrollment
12 participants
Start Date
May 12, 2026
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 18 YearsMax Age: 55 Years
Inclusion Criteria2
- Body mass index of 18.5 to 32.0 kg/m2, inclusive.
- Total body weight >= 50 kg.
Exclusion Criteria7
- 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
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Interventions
DRUGEmraclidine
Oral tablet
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07587008
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