A Study to Assess the Adverse Events and How Oral Emraclidine Moves Through the Body of Healthy Elderly Adult Participants
- Registration Number
- NCT07219030
- Lead Sponsor
- AbbVie
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 32
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Emraclidine or Placebo- Group 1 Emraclidine Participants will receive oral doses of emraclidine or placebo for 10 days or 17 day Emraclidine or Placebo- Group 1 Placebo Participants will receive oral doses of emraclidine or placebo for 10 days or 17 day Emraclidine or Placebo- Group 3 Placebo Participants will receive oral doses of emraclidine or placebo for 10 days or 17 day Emraclidine or Placebo- Group 4 Emraclidine Participants will receive oral doses of emraclidine or placebo for 10 days or 17 day Emraclidine or Placebo- Group 4 Placebo Participants will receive oral doses of emraclidine or placebo for 10 days or 17 day Emraclidine or Placebo- Group 2 Emraclidine Participants will receive oral doses of emraclidine or placebo for 10 days or 17 day Emraclidine or Placebo- Group 2 Placebo Participants will receive oral doses of emraclidine or placebo for 10 days or 17 day Emraclidine or Placebo- Group 3 Emraclidine Participants will receive oral doses of emraclidine or placebo for 10 days or 17 day
- Primary Outcome Measures
Name Time Method Minimum plasma concentration (Cmin) of Metabolite (CV-0000364) Up to approximately 20 days Cmin of Metabolite (CV-0000364)
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)
Minimum plasma concentration (Cmin) of Emraclidine Up to approximately 20 days Cmin of Emraclidine
Average plasma concentration (Cavg) of Emraclidine Up to approximately 20 days Cavg of Emraclidine
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 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 plasma concentration-time curve over the dosing interval (AUCtau) of Emraclidine Up to approximately 20 days AUCtau 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)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
ACPRU
🇺🇸Grayslake, Illinois, United States
ACPRU🇺🇸Grayslake, Illinois, United States