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The primary purpose of this study is to assess the effect of hepatic impairment on the pharmacokinetics (PK) of emraclidine following administration of a single oral dose in participants with mild, moderate, and severe hepatic impairment relative to matched participants with normal hepatic function.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Severe Hepatic Impairment | Experimental | Participants will receive a single oral dose of 10 milligrams (mg) emraclidine. |
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| Moderate Hepatic Impairment | Experimental | Participants will receive a single oral dose of 10 mg emraclidine. |
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| Mild Hepatic Impairment | Experimental | Participants will receive a single oral dose of 10 mg emraclidine. |
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| Normal Hepatic Function | Experimental | Participants will receive a single oral dose of 10 mg emraclidine. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Emraclidine | Drug | Tablet |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) of Emraclidine | Pre-dose and at multiple timepoints post-dose up to Day 7 | |
| Maximum Observed Unbound Plasma Concentration (Cmax,u) of Emraclidine | Pre-dose and at multiple timepoints post-dose up to Day 7 | |
| Area Under the Plasma Concentration-time Curve from Time Zero to t (AUC0-t) of Emraclidine | Pre-dose and at multiple timepoints post-dose up to Day 7 | |
| Area Under the Unbound Plasma Concentration-time Curve from Time Zero to t (AUC0-t,u) of Emraclidine | Pre-dose and at multiple timepoints post-dose up to Day 7 | |
| Area Under the Plasma Concentration-time Curve from Time Zero to Infinity (AUCinf) of Emraclidine | Pre-dose and at multiple timepoints post-dose up to Day 7 | |
| Area Under the Unbound Plasma Concentration-time Curve From Time Zero to Infinity (AUCinf,u) of Emraclidine | Pre-dose and at multiple timepoints post-dose up to Day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and Severity of Treatment Emergent Adverse Events (TEAEs) | Day 1 up to Follow-up (Day 15) | |
| Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Values | Days 1 to 7 |
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Key Inclusion Criteria:
All Participants
- Male and female participants, body mass index of ≥18.0 to 42.0 kilograms per meter square (kg/m^2), inclusive, and a total body weight ≥50 kilograms (kg) (110 pounds [lbs]).
Additional Inclusion Criteria for Participants With Normal Hepatic Function
Additional Inclusion Criteria for Participants With Hepatic Impairment - Participants with stable hepatic impairment that meets the criteria for Class A, Class B, or Class C of the modified Child-Pugh Classification. Stable hepatic disease defined as no clinically significant change in disease status in the last 28 days prior to the screening visit.
Key Exclusion Criteria:
For All Participants
Any condition or surgery that could possibly affect drug absorption, including, but not limited to, bowel resections, bariatric weight loss surgery/procedures, gastrectomy, and cholecystectomy.
Receipt of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccination or booster within 7 days of planned dosing.
Have recently been diagnosed with symptomatic coronavirus disease 2019 (COVID-19) or test positive for SARS-CoV-2 within 15 days prior to signing the informed consent form (ICF).
Positive drug screen or a positive test for alcohol at Screening or Baseline (Check-in/Day -1) Visits.
Use of prohibited medications prior to randomization or likely to require prohibited concomitant therapy during the trial.
Current use of tobacco or nicotine-containing products (cigarettes, cigars, chewing tobacco, snuff, e-cigarettes, etc). Note: Light smokers (<5 cigarettes/day or equivalent) are allowed provided they abstain from the use of tobacco- or nicotine-containing products for at least 2 hours prior to PK assessments.
Known allergy or hypersensitivity to the investigational medicinal product (IMP), closely related compounds, or any of their specified ingredients.
Has received IMP in a clinical trial of emraclidine within 12 months of signing the ICF.
Participants with a 12-lead ECG demonstrating any of the following at the Screening Visit and at Check-in (Day -1):
Blood pressure measurements demonstrating any of the following at the Screening Visit and/or at Check-in (Day -1):
Additional Exclusion Criteria for Participants with Hepatic Impairment
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| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Miami, Florida | Miami | Florida | 33136 | United States | ||
| Orlando, Florida |
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| Number of Participants With Clinically Significant Changes in Vital Signs | Days 1 to 7 |
| Number of Participants With Clinically Significant Changes in Laboratory Assessments | Days 1 to 7 |
| Number of Participants With Clinically Significant Changes in Physical and Neurological Examination Results | Days 1 to 7 |
| Changes in Columbia Suicide Severity Rating Scale (C-SSRS) Score | The C-SSRS includes 'yes' or 'no' responses for assessment of suicidal ideation and behavior as well as numeric ratings for severity of ideation, if present (from 1 to 5, with 5 being the most severe). Greater lethality or potential lethality of suicidal behaviors (endorsed on the behavior subscale) indicates increased risk. | Days 1 to 7 |
| Orlando |
| Florida |
| 32809 |
| United States |
| San Antonio, Texas | San Antonio | Texas | 78215 | United States |