Menu
Recruiting NCT07219030

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

Phase I Interventional Healthy Volunteer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Emraclidine, Placebo.
Who it may be relevant to
Registry conditions: Healthy Volunteer. Basic parameters: 65 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase 1, Randomized, Placebo-controlled Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Emraclidine Following Multiple Ascending Oral Doses in Healthy Elderly Subjects

Overview

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

Interventions

  • Drug Emraclidine
    Oral tablets
  • Drug Placebo
    Oral tablets

Primary outcome measures

  • Number of Participants Experiencing Adverse Events [Time frame: Up to approximately 50 days]
  • Number of Participants with Clinical Significant Change From Baseline in Vital Sign Measurements [Time frame: Up to approximately 20 days]
  • Number of Participants with Clinical Significant Change from Baseline in Electrocardiogram (ECG) [Time frame: Up to approximately 20 days]
  • Number of Participants with Clinical Significant Change in Physical Examinations [Time frame: Up to approximately 20 days]
  • Number of Participants with Clinical Significant Change in Clinical Laboratory Test Results Like Hematology will be Assessed [Time frame: Up to approximately 20 days]
  • Change from Baseline in Columbia-Suicide Severity Rating Scale (C-SSRS) [Time frame: Up to approximately 20 days]
  • Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) [Time frame: Up to approximately 20 days]
  • Change From Baseline in Barnes Akathisia Rating Scale (BARS) [Time frame: Up to approximately 20 days]
  • Change From Baseline in Simpson-Angus Scale (SAS) [Time frame: Up to approximately 20 days]
  • Maximum Observed Plasma Concentration (Cmax) of Emraclidine [Time frame: Up to approximately 20 days]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Sequential
Masking
Quadruple blind
Primary purpose
Basic science

Study locations

United States · 4 centers
  • Altasciences Clinical Los Angeles /ID# 276854 — Cypress
  • K2 Medical Research, LLC /ID# 276636 — Maitland
  • Clinical Pharmacology Of Miami /ID# 276856 — Miami
  • Acpru /Id# 276996 — Grayslake

Identifiers

NCT: NCT07219030 · M25-904

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗