A Study to Assess the Adverse Events and How Oral Emraclidine Moves Through the Body of Healthy Elderly Adult Participants
← catalyst calendarNCT07219030 · readout ≤ 224 d
Sponsored by AbbVie (industry) · ABBV — their whole pipeline →.
Phase
Phase 1
Status
Recruiting
Study type
Interventional
Design
Randomized · Quadruple · Basic science
Enrollment
40estimated
Sites
4
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2025-10-08 | actual | When the study began enrolling |
| Primary completion | Mar 2027 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Mar 2027 | estimated | The whole study's end, after follow-up |
| First posted | 2025-10-21 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-05-12 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Healthy Volunteer
Interventions
- Drug: Emraclidine
- Drug: Placebo
Primary outcomes
what the primary-completion date above is the date OFNumber of Participants Experiencing Adverse Events
measured Up to approximately 50 days
Number of Participants with Clinical Significant Change From Baseline in Vital Sign Measurements
measured Up to approximately 20 days
Number of Participants with Clinical Significant Change from Baseline in Electrocardiogram (ECG)
measured Up to approximately 20 days
Number of Participants with Clinical Significant Change in Physical Examinations
measured Up to approximately 20 days
Number of Participants with Clinical Significant Change in Clinical Laboratory Test Results Like Hematology will be Assessed
measured Up to approximately 20 days
Change from Baseline in Columbia-Suicide Severity Rating Scale (C-SSRS)
measured Up to approximately 20 days
Change From Baseline in Abnormal Involuntary Movement Scale (AIMS)
measured Up to approximately 20 days
Change From Baseline in Barnes Akathisia Rating Scale (BARS)
measured Up to approximately 20 days
Change From Baseline in Simpson-Angus Scale (SAS)
measured Up to approximately 20 days
Maximum Observed Plasma Concentration (Cmax) of Emraclidine
measured Up to approximately 20 days
Maximum Observed Plasma Concentration (Cmax) of Metabolite (CV-0000364)
measured Up to approximately 20 days
Time to Cmax (Tmax) of Emraclidine
measured Up to approximately 20 days
Time to Cmax (Tmax) of Metabolite (CV-0000364)
measured Up to approximately 20 days
Area Under the Concentration-Time Curve from Time 0 to Time t (AUCt) of Emraclidine
measured Up to approximately 20 days
Area Under the Concentration-Time Curve from Time 0 to Time t (AUCt) Metabolite (CV-000036)
measured Up to approximately 20 days
Area under the plasma concentration-time curve over the dosing interval (AUCtau) of Emraclidine
measured Up to approximately 20 days
Minimum plasma concentration (Cmin) of Emraclidine
measured Up to approximately 20 days
Minimum plasma concentration (Cmin) of Metabolite (CV-0000364)
measured Up to approximately 20 days
Average plasma concentration (Cavg) of Emraclidine
measured Up to approximately 20 days
Average plasma concentration (Cavg) of Metabolite (CV-0000364)
measured Up to approximately 20 days
Metabolite to Parent Ratio (MRCmax) of Emraclidine
measured Up to approximately 20 days
Metabolite to Parent Ratio (MRCmax) of Metabolite (CV-0000364)
measured Up to approximately 20 days
Metabolite to Parent Ratio (MRAUCtau) of Emraclidine
measured Up to approximately 20 days
Metabolite to Parent Ratio (MRAUCtau) of Metabolite (CV-000036)
measured Up to approximately 20 days
Terminal Phase Elimination Half-Life (t1/2) of Emraclidine
measured Up to approximately 20 days
Terminal Phase Elimination Half-Life (t1/2) of Metabolite (CV-000036)
measured Up to approximately 20 days
Apparent terminal phase elimination constant (β) of Emraclidine
measured Up to approximately 20 days
Apparent terminal phase elimination constant (β) of Metabolite (CV-0000364)
measured Up to approximately 20 days
Peak-to-trough ratio (PTR) of Emraclidine
measured Up to approximately 20 days
Peak-to-trough ratio (PTR) of Metabolite (CV-000036)
measured Up to approximately 20 days
Accumulation ratio for Cmax (RacCmax) of Emraclidine
measured Up to approximately 20 days
Accumulation ratio for Cmax (RacCmax) of Metabolite (CV-0000364)
measured Up to approximately 20 days
Accumulation ratio for AUCtau (RacAUCtau) of Emraclidine
measured Up to approximately 20 days
Accumulation ratio for AUCtau (RacAUCtau) of Metabolite (CV-0000364)
measured Up to approximately 20 days
Apparent Clearance of Drug from Plasma (CL/F) of Emraclidine
measured Up to approximately 20 days
Apparent Volume of Distribution DuringTerminal Phase (Vz/F) of Emraclidine
measured Up to approximately 20 days
Area under the plasma concentration-time curve over the dosing interval (AUCtau) of Metabolite (CV-0000364)
measured Up to approximately 20 days
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