A Study of Emraclidine for Adults with Schizophrenia
This study is looking at a new oral medication called emraclidine for adults with schizophrenia. Schizophrenia is a brain disorder that affects how a person thinks, feels, and behaves. The study wants to see how safe emraclidine is, if it helps with symptoms, and how it moves through your body. You would receive either emraclidine or a placebo (an inactive pill). About 268 people will join this study across the United States. To be eligible, you need to be between 18 and 65 years old, weigh over 110 lbs, and have a BMI between 18 and 40. Depending on which part of the study you join, there are also specific requirements about your current symptom severity.
- Study design
- This is an interventional study where participants will receive either oral emraclidine or a placebo. Approximately 268 participants will be enrolled.
- What's involved
- The study will assess adverse events and how emraclidine moves through the body for up to approximately 74 days.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for adverse events for up to approximately 74 days.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Study to Assess Adverse Events, Change in Disease Activity, and How Oral Emraclidine Moves Through the Body in Adult Participants With Schizophrenia
At a glance
Conditions
Where it's being run
7 sites across 5 statesStudy leadership
- ABBVIE INC. · STUDY_DIRECTOR · AbbVie
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Number of Participants with Adverse Events (AEs)Up to approximately 74 days
An adverse event (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. The investigator assesses the relationship of each event to the use of study.
- Part A Only-Maximum Observed Plasma Concentration (Cmax) of EmraclidineUp to approximately 24 days
Cmax of Emraclidine
- Part A Only-Time to Cmax (Tmax) of EmraclidineUp to approximately 24 days
Tmax of Emraclidine
- Part A Only-Area Under the Concentration-Time Curve from Time 0 to Time t (AUCt) of EmraclidineUp to approximately 24 days
AUCt of Emraclidine
- Part A Only-Area under the plasma concentration-time curve over the dosing interval (AUCtau) of EmraclidineUp to approximately 24 days
AUCtau of Emraclidine
- Part A Only-Maximum metabolite concentration (MRCmax) of EmraclidineUp to approximately 21 days
MRCmax of Emraclidine
- Part A Only- Area under the metabolite concentration-time curve over the dosing interval (MRAUCtau) of EmraclidineUp to approximately 21 days
MRAUCtau of Emraclidine
- Part A Only- Minimum plasma concentration (Cmin) of EmraclidineUp to approximately 21 days
Cmin of Emraclidine
- Part A Only-Average plasma concentration (Cavg) of EmraclidineUp to approximately 21 days
Cavg of Emraclidine
- Part A Only- Terminal Phase Elimination Half-Life (t1/2) of EmraclidineUp to approximately 21 days
Terminal phase elimination half-life of Emraclidine
- Part A Only-Terminal elimination rate constant (λz) of EmraclidineUp to approximately 21 days
λz of Emraclidine
- Part A Only-Apparent Clearance of Drug from Plasma (CL/F) of EmraclidineUp to approximately 21 days
CL/F of Emraclidine
- Part A Only-Apparent Volume of Distribution DuringTerminal Phase (Vz/F) of EmraclidineUp to approximately 21 days
Vz/F of Emraclidine
- Part A Only-Peak-to-trough ratio (PTR) of EmraclidineUp to approximately 21 days
PTR of Emraclidine
- Part A Only- Accumulation ratio for Cmax (RacCmax) of EmraclidineUp to approximately 21 days
RacCmax of Emraclidine
- Part A Only-Accumulation ratio for AUCta (RacAUCtau) of EmraclidineUp to approximately 21 days
RacAUCta of Emraclidine
- Part A Only-Maximum Observed Plasma Concentration (Cmax) of Metabolite (CV-0000364)Up to approximately 24 days
Cmax of Metabolite (CV-0000364)
- Part A Only-Time to Cmax (Tmax) of Metabolite (CV-0000364)Up to approximately 24 days
Tmax of Metabolite (CV-000036)
- Part A Only-Area under the plasma concentration-time curve over the dosing interval (AUCtau) of Metabolite (CV-000036)Up to approximately 24 days
AUCtau of Metabolite (CV-000036)
- Part A Only-Area Under the Concentration-Time Curve from Time 0 to Time t (AUCt) Metabolite (CV-000036)Up to approximately 24 days
AUCt of Metabolite (CV-000036)
- Part A Only-Maximum metabolite concentration (MRCmax) of Metabolite (CV-000036)Up to approximately 21 days
MRCmax of Metabolite (CV-000036)
- Part A Only- Area under the metabolite concentration-time curve over the dosing interval (MRAUCtau) of Metabolite (CV-000036)Up to approximately 21 days
MRAUCtau of Metabolite (CV-000036)
- Part B Only-Change from Baseline in Positive and Negative Syndrome Scale (PANSS) total scoreUp to approximately week 6
PANSS is a 30-item clinician-reported rating scale which assesses both the positive and negative symptom syndromes of patients with schizophrenia. The PANSS consists of 3 subscales containing a total of 30 symptom constructs. For each symptom construct, severity is rated on a 7-point scale, with a score of 1 indicating the absence of symptoms and a score of 7 indicating extremely severe symptoms.