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The primary purpose of this study is to assess the effect of renal impairment on the pharmacokinetics (PK) of emraclidine following administration of a single oral dose in participants with mild, moderate, and severe renal impairment relative to matched participants with normal renal function.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mild Renal Impairment | Experimental | Participants will receive a single oral dose of 10 milligrams (mg) emraclidine on Day 1. |
|
| Moderate Renal Impairment | Experimental | Participants will receive a single oral dose of 10 mg emraclidine on Day 1. |
|
| Severe Renal Impairment | Experimental | Participants will receive a single oral dose of 10 mg emraclidine on Day 1. |
|
| Normal Renal Function | Experimental | Participants will receive a single oral dose of 10 mg emraclidine on Day 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Emraclidine | Drug | Oral tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) of Emraclidine | Pre-dose and at multiple timepoints post-dose up to Day 5 | |
| Maximum Observed Unbound Plasma Concentration (Cmax,u) of Emraclidine | Pre-dose and at multiple timepoints post-dose up to Day 5 | |
| 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 5 | |
| 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 5 | |
| 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 5 | |
| 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 5 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and Severity of Treatment Emergent Adverse Events (TEAEs) | Up to Day 15 | |
| Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Values | Up to Day 5 | |
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Key Inclusion Criteria:
For All Participants
Additional Criteria for Participants With Normal Renal Function
Additional Criteria for Participants With Renal Impairment
Key Exclusion Criteria:
For All Participants
"Yes" responses for any of the following items on the C-SSRS (within the individual's lifetime):
Serious risk of suicide in the opinion of the investigator is also exclusionary.
History of moderate to severe substance or alcohol-use disorder (excluding nicotine or caffeine) as per DSM-5 criteria within 12 months prior to signing the informed consent form (ICF).
Receipt of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccination or booster within 7 days of planned dosing.
In addition, participants who plan to receive SARS-CoV-2 vaccination or booster while participating in the trial or for a minimum of 7 days (to cover at least 5 half-lives of IMP) after the last dose of investigational medicinal product (IMP) will be excluded.
- Have recently been diagnosed with symptomatic coronavirus disease-2019 (COVID-19) or test positive (i.e., using polymerase chain reaction [PCR] or rapid antigen test) for SARS-CoV-2 within 15 days prior to signing the ICF.
Additional Criteria for Participants With Normal Renal Function
- Current or past history of significant cardiovascular, pulmonary, gastrointestinal, renal, hepatic, metabolic, genitourinary, endocrine (including diabetes mellitus), malignancy (except for surgically excised non-melanomatous skin cancers or in situ cervical cancer, at the discretion of the investigator), hematological, immunological, neurological, or psychiatric disease that, in the opinion of the investigator or medical monitor, could compromise either participant safety or the results of the trial.
Additional Criteria for Participants With Renal Impairment
NOTE: Other protocol-defined inclusion/exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tustin, California | Tustin | California | 92780 | United States | ||
| Miami, Florida |
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|
| Number of Participants With Clinically Significant Changes in Vital Signs |
| Up to Day 5 |
| Number of Participants With Clinically Significant Change in Laboratory Assessments | Up to Day 5 |
| Number of Participants With Clinically Significant Change in Physical and Neurological Examination Results | Up to Day 5 |
| 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. | Up to Day 5 |
| Miami |
| Florida |
| 33014 |
| United States |
| Miami, Florida | Miami | Florida | 33136 | United States |
| Orlando, Florida | Orlando | Florida | 32808 | United States |
| Knoxville, Tennessee | Knoxville | Tennessee | 37920 | United States |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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