A Study to Assess the Adverse Events and How Oral Emraclidine Moves Through the Body of Healthy Elderly Adult Participants

Condition(s) studied

Investigational drug(s) / intervention(s)

Emraclidine: Oral tablets

Placebo: Oral tablets

Study summary

This study is to assess how oral emraclidine moves through the body of healthy elderly adult participants, and assess adverse events, and tolerability.

Eligibility

Primary outcome measure(s)

• 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)

Trial sites (5)

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