Emraclidine Pharmacokinetics in Liver Disease
Recruiting in Palo Alto (17 mi)
+2 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Waitlist Available
Sponsor: AbbVie
No Placebo Group
Trial Summary
What is the purpose of this trial?
This trial studies how a medication called emraclidine is processed in people with liver problems. It includes participants with mild, moderate, and severe liver issues. The goal is to see how liver function affects the drug's movement and breakdown in the body.
Research Team
AI
ABBVIE INC.
Principal Investigator
AbbVie
Eligibility Criteria
This trial is for adults with stable liver disease, classified as Class A, B, or C by the Child-Pugh Classification. They must have a BMI of 18-42 kg/m^2 and weigh at least 50 kg. Healthy participants with normal liver function are also eligible. Exclusions include recent drug trials participation, surgeries affecting drug absorption, COVID-19 diagnosis or vaccination within specific timeframes before the trial, substance abuse, certain medication use, tobacco/nicotine use (except light smokers who abstain before PK assessments), known allergies to emraclidine or its ingredients, abnormal ECG results or blood pressure readings.Inclusion Criteria
My BMI is between 18.0 and 42.0, and I weigh at least 50 kg.
My liver function is stable, but impaired.
My liver functions are within normal ranges.
Exclusion Criteria
I have a condition or had surgery that affects how drugs are absorbed in my body.
Known allergy to IMP or related compounds
I have liver problems and my kidney function is reduced.
See 7 more
Treatment Details
Interventions
- Emraclidine (Other)
Trial OverviewThe study tests how different levels of liver impairment affect the body's handling of a single oral dose of Emraclidine compared to those with normal liver function. It measures how much and how quickly Emraclidine appears in the bloodstream and is processed by individuals with varying degrees of hepatic impairment.
Participant Groups
4Treatment groups
Experimental Treatment
Group I: Severe Hepatic ImpairmentExperimental Treatment1 Intervention
Participants will receive a single oral dose of 10 milligrams (mg) emraclidine.
Group II: Normal Hepatic FunctionExperimental Treatment1 Intervention
Participants will receive a single oral dose of 10 mg emraclidine.
Group III: Moderate Hepatic ImpairmentExperimental Treatment1 Intervention
Participants will receive a single oral dose of 10 mg emraclidine.
Group IV: Mild Hepatic ImpairmentExperimental Treatment1 Intervention
Participants will receive a single oral dose of 10 mg emraclidine.
Find a Clinic Near You
Who Is Running the Clinical Trial?
AbbVie
Lead Sponsor
Trials
1,079
Recruited
535,000+
Founded
2013
Headquarters
North Chicago, USA
Known For
Immunology treatments
Top Products
Humira (adalimumab), Skyrizi (risankizumab), Rinvoq (upadacitinib)
Dr. Roopal Thakkar
AbbVie
Chief Medical Officer since 2023
MD from Wayne State University School of Medicine
Robert A. Michael
AbbVie
Chief Executive Officer
Bachelor's degree in Finance from the University of Illinois
Cerevel Therapeutics, LLC
Lead Sponsor
Trials
37
Recruited
5,500+