Healthy Volunteer
Conditions
Keywords
Healthy Volunteer, ABBV-1231
Brief summary
This study is to assess how oral emraclidine moves through the body of healthy elderly adult participants, and assess adverse events, and tolerability.
Interventions
DRUGEmraclidine
Oral tablets
DRUGPlacebo
Oral tablets
Sponsors
AbbVie
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
* BMI is ≥ 18.0 to ≤ 32.0 kg/m2 after rounding to the tenths decimal at Screening. BMI is calculated as weight in kg divided by the square of height measured in meters. * Body weight \> 45 kg at the time of screening and upon initial confinement. * A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead ECG.
Exclusion criteria
* History of any clinically significant cardiac, respiratory (except mild asthma as a child), renal, hepatic, gastrointestinal, genitourinary, immunological, hematologic, neurological or psychiatric disease or disorder, or any other uncontrolled medical illness. * History of any clinically significant sensitivity or allergy to any medication or food. * Evidence of dysplasia or history of malignancy (including lymphoma and leukemia) other than successfully treated non-metastatic cutaneous squamous cell, basal cell carcinoma or localized carcinoma in situ of the cervix.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Experiencing Adverse Events | Up to approximately 50 days | 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. |
| Number of Participants with Clinical Significant Change From Baseline in Vital Sign Measurements | Up to approximately 20 days | Number of participants with clinical significant change from baseline in vital sign measurements like systolic and diastolic blood pressure will be assessed. |
| Number of Participants with Clinical Significant Change from Baseline in Electrocardiogram (ECG) | Up to approximately 20 days | 12-lead resting ECG will be recorded. |
| Number of Participants with Clinical Significant Change in Physical Examinations | Up to approximately 20 days | Number of participants with clinical significant change in physical examinations will be assessed. |
| Number of Participants with Clinical Significant Change in Clinical Laboratory Test Results Like Hematology will be Assessed | Up to approximately 20 days | Number of participants with clinical significant change in clinical laboratory test results will be assessed. |
| Change from Baseline in Columbia-Suicide Severity Rating Scale (C-SSRS) | Up to approximately 20 days | 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. |
| Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) | Up to approximately 20 days | 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. |
| Change From Baseline in Barnes Akathisia Rating Scale (BARS) | Up to approximately 20 days | 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 \[5\]). |
| Change From Baseline in Simpson-Angus Scale (SAS) | Up to approximately 20 days | 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. |
| Maximum Observed Plasma Concentration (Cmax) of Emraclidine | Up to approximately 20 days | Cmax of Emraclidine |
| Maximum Observed Plasma Concentration (Cmax) of Metabolite (CV-0000364) | Up to approximately 20 days | Cmax of Metabolite (CV-0000364) |
| Time to Cmax (Tmax) of Emraclidine | Up to approximately 20 days | Tmax of Emraclidine |
| Time to Cmax (Tmax) of Metabolite (CV-0000364) | Up to approximately 20 days | Tmax of Metabolite (CV-000036) |
| Area Under the Concentration-Time Curve from Time 0 to Time t (AUCt) of Emraclidine | Up to approximately 20 days | AUCt of Emraclidine |
| Area Under the Concentration-Time Curve from Time 0 to Time t (AUCt) Metabolite (CV-000036) | Up to approximately 20 days | AUCt of Metabolite (CV-000036) |
| Area under the plasma concentration-time curve over the dosing interval (AUCtau) of Emraclidine | Up to approximately 20 days | AUCtau of Emraclidine |
| Minimum plasma concentration (Cmin) of Emraclidine | Up to approximately 20 days | Cmin of Emraclidine |
| Minimum plasma concentration (Cmin) of Metabolite (CV-0000364) | Up to approximately 20 days | Cmin of Metabolite (CV-0000364) |
| Average plasma concentration (Cavg) of Emraclidine | Up to approximately 20 days | Cavg of Emraclidine |
| Average plasma concentration (Cavg) of Metabolite (CV-0000364) | Up to approximately 20 days | Cavg of Metabolite (CV-0000364) |
| Metabolite to Parent Ratio (MRCmax) of Emraclidine | Up to approximately 20 days | MRCmax of Emraclidine calculated from Cmax |
| Metabolite to Parent Ratio (MRCmax) of Metabolite (CV-0000364) | Up to approximately 20 days | MRCmax of Metabolite (CV-0000364) calculated from Cmax |
| Metabolite to Parent Ratio (MRAUCtau) of Emraclidine | Up to approximately 20 days | MRAUCtau of Emraclidine based on AUCtau |
| Metabolite to Parent Ratio (MRAUCtau) of Metabolite (CV-000036) | Up to approximately 20 days | MRAUCtau of Metabolite (CV-000036) based on AUCtau |
| Terminal Phase Elimination Half-Life (t1/2) of Emraclidine | Up to approximately 20 days | Terminal phase elimination half-life of Emraclidine |
| Terminal Phase Elimination Half-Life (t1/2) of Metabolite (CV-000036) | Up to approximately 20 days | Terminal phase elimination half-life of Metabolite (CV-000036) |
| Apparent terminal phase elimination constant (β) of Emraclidine | Up to approximately 20 days | β of Emraclidine |
| Apparent terminal phase elimination constant (β) of Metabolite (CV-0000364) | Up to approximately 20 days | β of Metabolite (CV-0000364) |
| Peak-to-trough ratio (PTR) of Emraclidine | Up to approximately 20 days | PTR of Emraclidine |
| Peak-to-trough ratio (PTR) of Metabolite (CV-000036) | Up to approximately 20 days | PTR of Metabolite (CV-000036) |
| Accumulation ratio for Cmax (RacCmax) of Emraclidine | Up to approximately 20 days | RacCmax of Emraclidine |
| Accumulation ratio for Cmax (RacCmax) of Metabolite (CV-0000364) | Up to approximately 20 days | RacCmax of Metabolite (CV-0000364) |
| Accumulation ratio for AUCtau (RacAUCtau) of Emraclidine | Up to approximately 20 days | RacAUCtau of Emraclidine |
| Accumulation ratio for AUCtau (RacAUCtau) of Metabolite (CV-0000364) | Up to approximately 20 days | RacAUCtau of Metabolite (CV-0000364) |
| Apparent Clearance of Drug from Plasma (CL/F) of Emraclidine | Up to approximately 20 days | CL/F of Emraclidine |
| Apparent Volume of Distribution DuringTerminal Phase (Vz/F) of Emraclidine | Up to approximately 20 days | Vz/F of Emraclidine |
| Area under the plasma concentration-time curve over the dosing interval (AUCtau) of Metabolite (CV-0000364) | Up to approximately 20 days | AUCtau of Metabolite (CV-0000364) |
Countries
United States
Contacts
CONTACTABBVIE CALL CENTER
STUDY_DIRECTORABBVIE INC.
AbbVie
Outcome results
None listed