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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1 | Experimental | Participants will receive Emraclidine in 3 different formulations in Sequence 1. |
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| Sequence 2 | Experimental | Participants will receive Emraclidine in 3 different formulations in Sequence 2. |
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| Sequence 3 | Experimental | Participants will receive Emraclidine in 3 different formulations in Sequence 3. |
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| Sequence 4 | Experimental | Participants will receive Emraclidine in 3 different formulations in Sequence 4. |
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| Sequence 5 | Experimental | Participants will receive Emraclidine in 3 different formulations in Sequence 5. |
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| Sequence 6 | Experimental | Participants will receive Emraclidine in 3 different formulations in Sequence 6. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Emraclidine | Drug | Oral tablet |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events (AEs) | An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study. | Up to approximately 44 days |
| Maximum Observed Plasma Concentration (Cmax) of Emraclidine | Cmax of Emraclidine. | Up to approximately 14 days |
| Time to Cmax (Tmax) of Emraclidine | Tmax of Emraclidine. | Up to approximately 14 days |
| Area Under the Concentration-Time Curve from Time 0 to Time t (AUC) of Emraclidine | AUC of Emraclidine. | Up to approximately 14 days |
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Inclusion Criteria:
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:
Female participants of childbearing potential
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ABBVIE CALL CENTER | Contact | 844-663-3742 | abbvieclinicaltrials@abbvie.com |
| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Acpru /Id# 283349 | Recruiting | Grayslake | Illinois | 60030 | United States |
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