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

Purpose

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

Condition

  • Healthy Volunteer

Eligibility

Eligible Ages
Between 65 Years and 85 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

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.

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Basic Science
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Emraclidine or Placebo- Group 1 		Participants will receive oral doses of emraclidine or placebo for 10 days or 17 days
  • Drug: Emraclidine
    Oral tablets
  • Drug: Placebo
    Oral tablets
Experimental
Emraclidine or Placebo- Group 2 		Participants will receive oral doses of emraclidine or placebo for 10 days or 17 days
  • Drug: Emraclidine
    Oral tablets
  • Drug: Placebo
    Oral tablets
Experimental
Emraclidine or Placebo- Group 3 		Participants will receive oral doses of emraclidine or placebo for 10 days or 17 days.
  • Drug: Emraclidine
    Oral tablets
  • Drug: Placebo
    Oral tablets
Experimental
Emraclidine or Placebo- Group 4 		Participants will receive oral doses of emraclidine or placebo for 10 days or 17 days.
  • Drug: Emraclidine
    Oral tablets
  • Drug: Placebo
    Oral tablets
Experimental
Emraclidine or Placebo- Group 5 		Participants will receive oral doses of emraclidine or placebo for 10 days or 17 days.
  • Drug: Emraclidine
    Oral tablets
  • Drug: Placebo
    Oral tablets

Recruiting Locations

Altasciences Clinical Los Angeles /ID# 276854
Cypress, California 90630

K2 Medical Research, LLC /ID# 276636
Maitland, Florida 32751

Clinical Pharmacology Of Miami /ID# 276856
Miami, Florida 33172
Contact:
Site Coordinator
786-493-9466

Acpru /Id# 276996
Grayslake, Illinois 60030
Contact:
Site Coordinator
847-935-4400

More Details

Status
Recruiting
Sponsor
AbbVie

Study Contact

ABBVIE CALL CENTER
844-663-3742
abbvieclinicaltrials@abbvie.com