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

NCT ID: NCT07219030

Last Updated: 2025-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-08

Study Completion Date

2026-11-30

Brief Summary

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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

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Conditions

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Healthy Volunteer

Keywords

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Healthy Volunteer ABBV-1231

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Emraclidine or Placebo- Group 1

Participants will receive oral doses of emraclidine or placebo for 10 days or 17 days

Group Type EXPERIMENTAL

Emraclidine

Intervention Type DRUG

Oral tablets

Placebo

Intervention Type DRUG

Oral tablets

Emraclidine or Placebo- Group 2

Participants will receive oral doses of emraclidine or placebo for 10 days or 17 days

Group Type EXPERIMENTAL

Emraclidine

Intervention Type DRUG

Oral tablets

Placebo

Intervention Type DRUG

Oral tablets

Emraclidine or Placebo- Group 3

Participants will receive oral doses of emraclidine or placebo for 10 days or 17 days.

Group Type EXPERIMENTAL

Emraclidine

Intervention Type DRUG

Oral tablets

Placebo

Intervention Type DRUG

Oral tablets

Emraclidine or Placebo- Group 4

Participants will receive oral doses of emraclidine or placebo for 10 days or 17 days.

Group Type EXPERIMENTAL

Emraclidine

Intervention Type DRUG

Oral tablets

Placebo

Intervention Type DRUG

Oral tablets

Interventions

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Emraclidine

Oral tablets

Intervention Type DRUG

Placebo

Oral tablets

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

65 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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AbbVie

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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ABBVIE INC.

Role: STUDY_DIRECTOR

AbbVie

Locations

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Altasciences Clinical Los Angeles /ID# 276854

Cypress, California, United States

Site Status RECRUITING

K2 Medical Research, LLC /ID# 276636

Maitland, Florida, United States

Site Status RECRUITING

Clinical Pharmacology Of Miami /ID# 276856

Miami, Florida, United States

Site Status RECRUITING

Acpru /Id# 276996

Grayslake, Illinois, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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ABBVIE CALL CENTER

Role: CONTACT

Phone: 844-663-3742

Email: [email protected]

Facility Contacts

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Site Coordinator

Role: primary

Site Coordinator

Role: primary

Related Links

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https://www.abbvieclinicaltrials.com/study/?id=M25-904

Related Info

Other Identifiers

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M25-904

Identifier Type: -

Identifier Source: org_study_id