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This study is to assess how oral emraclidine moves through the body of healthy elderly adult participants, and assess adverse events, and tolerability.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Emraclidine or Placebo- Group 1 | Experimental | Participants will receive oral doses of emraclidine or placebo for 10 days or 17 days |
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| Emraclidine or Placebo- Group 2 | Experimental | Participants will receive oral doses of emraclidine or placebo for 10 days or 17 days |
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| Emraclidine or Placebo- Group 3 | Experimental | Participants will receive oral doses of emraclidine or placebo for 10 days or 17 days. |
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| Emraclidine or Placebo- Group 4 | Experimental | Participants will receive oral doses of emraclidine or placebo for 10 days or 17 days. |
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| Emraclidine or Placebo- Group 5 | Experimental | Participants will receive oral doses of emraclidine or placebo for 10 days or 17 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Emraclidine | Drug | Oral tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Experiencing Adverse Events | An 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. | Up to approximately 50 days |
| Number of Participants with Clinical Significant Change From Baseline in Vital Sign Measurements | Number of participants with clinical significant change from baseline in vital sign measurements like systolic and diastolic blood pressure will be assessed. | Up to approximately 20 days |
| Number of Participants with Clinical Significant Change from Baseline in Electrocardiogram (ECG) | 12-lead resting ECG will be recorded. | Up to approximately 20 days |
| Number of Participants with Clinical Significant Change in Physical Examinations | Number of participants with clinical significant change in physical examinations will be assessed. | Up to approximately 20 days |
| Number of Participants with Clinical Significant Change in Clinical Laboratory Test Results Like Hematology will be Assessed | Number of participants with clinical significant change in clinical laboratory test results will be assessed. | Up to approximately 20 days |
| Change from Baseline in Columbia-Suicide Severity Rating Scale (C-SSRS) | The C-SSRS is a clinician-rated instrument that reports the severity of both suicidal ideation and behavior, with a higher score denoting more severe suicidal ideation and behavior. |
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Inclusion Criteria:
Exclusion Criteria:
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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 |
|---|---|---|---|---|---|---|
| Altasciences Clinical Los Angeles /ID# 276854 | Recruiting | Cypress | California | 90630 | United States | |
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| Placebo | Drug | Oral tablets |
|
| Up to approximately 20 days |
| Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) | AIMS assesses abnormal involuntary movements, such as tardive dyskinesia, associated with antipsychotic drugs; it measures facial, oral, extremities, and trunk movements, as well as the participant's awareness of abnormal movements. The first 10 items are rated on a none (0) to severe (4) scale. There are an additional 2 items on dental status that are answered yes or no. | Up to approximately 20 days |
| Change From Baseline in Barnes Akathisia Rating Scale (BARS) | BARS is a 4-item rating scale used to assess drug-induced akathisia. The scale comprises items for rating the observable restless movements that characterize the condition, the subjective awareness of restlessness, and any distress associated with the akathisia (each on a 4-point scale from normal [0] to severe [3]). In addition, there is a global severity for akathisia rated on a 6-point scale (absent [0] to severe akathisia [5]). | Up to approximately 20 days |
| Change From Baseline in Simpson-Angus Scale (SAS) | SAS is a 10-item rating scale for assessment of antipsychotic-induced parkinsonism in both clinical practice and research settings. Each item ranges from 0 (normal) to 4 (extreme symptoms). The scale consists of 1 item measuring gait (hypokinesia), 6 items measuring rigidity, and 3 items measuring glabella tap, tremor, and salivation, respectively. | Up to approximately 20 days |
| Maximum Observed Plasma Concentration (Cmax) of Emraclidine | Cmax of Emraclidine | Up to approximately 20 days |
| Maximum Observed Plasma Concentration (Cmax) of Metabolite (CV-0000364) | Cmax of Metabolite (CV-0000364) | Up to approximately 20 days |
| Time to Cmax (Tmax) of Emraclidine | Tmax of Emraclidine | Up to approximately 20 days |
| Time to Cmax (Tmax) of Metabolite (CV-0000364) | Tmax of Metabolite (CV-000036) | Up to approximately 20 days |
| Area Under the Concentration-Time Curve from Time 0 to Time t (AUCt) of Emraclidine | AUCt of Emraclidine | Up to approximately 20 days |
| Area Under the Concentration-Time Curve from Time 0 to Time t (AUCt) Metabolite (CV-000036) | AUCt of Metabolite (CV-000036) | Up to approximately 20 days |
| Area under the plasma concentration-time curve over the dosing interval (AUCtau) of Emraclidine | AUCtau of Emraclidine | Up to approximately 20 days |
| Minimum plasma concentration (Cmin) of Emraclidine | Cmin of Emraclidine | Up to approximately 20 days |
| Minimum plasma concentration (Cmin) of Metabolite (CV-0000364) | Cmin of Metabolite (CV-0000364) | Up to approximately 20 days |
| Average plasma concentration (Cavg) of Emraclidine | Cavg of Emraclidine | Up to approximately 20 days |
| Average plasma concentration (Cavg) of Metabolite (CV-0000364) | Cavg of Metabolite (CV-0000364) | Up to approximately 20 days |
| Metabolite to Parent Ratio (MRCmax) of Emraclidine | MRCmax of Emraclidine calculated from Cmax | Up to approximately 20 days |
| Metabolite to Parent Ratio (MRCmax) of Metabolite (CV-0000364) | MRCmax of Metabolite (CV-0000364) calculated from Cmax | Up to approximately 20 days |
| Metabolite to Parent Ratio (MRAUCtau) of Emraclidine | MRAUCtau of Emraclidine based on AUCtau | Up to approximately 20 days |
| Metabolite to Parent Ratio (MRAUCtau) of Metabolite (CV-000036) | MRAUCtau of Metabolite (CV-000036) based on AUCtau | Up to approximately 20 days |
| Terminal Phase Elimination Half-Life (t1/2) of Emraclidine | Terminal phase elimination half-life of Emraclidine | Up to approximately 20 days |
| Terminal Phase Elimination Half-Life (t1/2) of Metabolite (CV-000036) | Terminal phase elimination half-life of Metabolite (CV-000036) | Up to approximately 20 days |
| Apparent terminal phase elimination constant (β) of Emraclidine | β of Emraclidine | Up to approximately 20 days |
| Apparent terminal phase elimination constant (β) of Metabolite (CV-0000364) | β of Metabolite (CV-0000364) | Up to approximately 20 days |
| Peak-to-trough ratio (PTR) of Emraclidine | PTR of Emraclidine | Up to approximately 20 days |
| Peak-to-trough ratio (PTR) of Metabolite (CV-000036) | PTR of Metabolite (CV-000036) | Up to approximately 20 days |
| Accumulation ratio for Cmax (RacCmax) of Emraclidine | RacCmax of Emraclidine | Up to approximately 20 days |
| Accumulation ratio for Cmax (RacCmax) of Metabolite (CV-0000364) | RacCmax of Metabolite (CV-0000364) | Up to approximately 20 days |
| Accumulation ratio for AUCtau (RacAUCtau) of Emraclidine | RacAUCtau of Emraclidine | Up to approximately 20 days |
| Accumulation ratio for AUCtau (RacAUCtau) of Metabolite (CV-0000364) | RacAUCtau of Metabolite (CV-0000364) | Up to approximately 20 days |
| Apparent Clearance of Drug from Plasma (CL/F) of Emraclidine | CL/F of Emraclidine | Up to approximately 20 days |
| Apparent Volume of Distribution DuringTerminal Phase (Vz/F) of Emraclidine | Vz/F of Emraclidine | Up to approximately 20 days |
| Area under the plasma concentration-time curve over the dosing interval (AUCtau) of Metabolite (CV-0000364) | AUCtau of Metabolite (CV-0000364) | Up to approximately 20 days |
| K2 Medical Research, LLC /ID# 276636 |
| Recruiting |
| Maitland |
| Florida |
| 32751 |
| United States |
| Clinical Pharmacology Of Miami /ID# 276856 | Recruiting | Miami | Florida | 33172 | United States |
|
| Acpru /Id# 276996 | Recruiting | Grayslake | Illinois | 60030 | United States |
|