Oral emraclidine absorption and tolerability in healthy older adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Hassman Research Institute Marlton Site /ID# 276876
  Marlton, New Jersey, United States Recruiting
• Altasciences Clinical Los Angeles /ID# 276854
  Cypress, California, United States Completed

Study contacts

• Study coordinator: Abbvie Call Center
• Email: abbvieclinicaltrials@abbvie.com
• Phone: 844-663-3742

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.