Oral emraclidine absorption and tolerability in healthy older adults

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

This trial will test how the pill emraclidine moves through the body and how well healthy older adults tolerate it.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 65 Years to 85 Years
• Sex: All
• Sponsor: AbbVie (Industry-sponsored)
• Locations: 4 sites (Cypress, California and 3 other locations)
• Trial ID: NCT07219030 on ClinicalTrials.gov

What this trial studies

This Phase 1 interventional trial gives oral emraclidine or placebo to healthy elderly participants to characterize pharmacokinetics and monitor adverse events. Participants will receive oral doses and undergo timed blood sampling and other measures to track how the drug is absorbed, distributed, metabolized, and eliminated. Safety monitoring includes recording adverse events, vital signs, laboratory tests, and ECGs, and eligible volunteers must be in generally good health with specified BMI and weight limits. The study is sponsored by AbbVie and is being conducted at clinical pharmacology sites in California and Florida.

Who should consider this trial

Good fit: Healthy older adults in generally good health who meet the BMI (18.0–32.0 kg/m2) and weight (>45 kg) criteria and have no significant medical conditions are ideal candidates.

Not a fit: People with significant cardiac, respiratory (beyond mild childhood asthma), renal, hepatic, neurological, psychiatric, immunologic, hematologic conditions, recent or active malignancy, or significant medication/food allergies are excluded and unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the results could define safe dosing ranges and tolerability of emraclidine in older adults and guide later clinical studies.

How similar studies have performed: Early-phase pharmacokinetic and tolerability studies are a standard first step and have successfully characterized many oral drugs, though emraclidine itself is being tested here for this population.

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.

Where this trial is running

Cypress, California and 3 other locations

• Altasciences Clinical Los Angeles /ID# 276854 — Cypress, California, United States (Recruiting)
• K2 Medical Research, LLC /ID# 276636 — Maitland, Florida, United States (Recruiting)
• Clinical Pharmacology Of Miami /ID# 276856 — Miami, Florida, United States (Recruiting)
• Acpru /Id# 276996 — Grayslake, Illinois, United States (Recruiting)

Study contacts

• Study coordinator: Abbvie Call Center

Conditions Healthy Volunteer; ABBV-1231