Actively Recruiting
A Phase 1 Study to Evaluate the Effect of Multiple Doses of ABBV-722 on the Pharmacokinetics of Cocktail Probe Substrates of CYP3A and Select Transporters in Healthy Adult Subjects
Led by AbbVie · Updated on 2026-05-05
12
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to assess how repeated doses of the drug ABBV-722 affect the levels of several other medications, including Midazolam, Digoxin, Pitavastatin, Metformin, and Sitagliptin, in healthy adult volunteers. The study is a Phase 1 trial conducted by AbbVie to understand these interactions and their implications for drug metabolism and transport. During the study, participants will first receive a single dose of Midazolam along with other selected transporter substrates in Period 1. In Period 2, participants will take daily single doses of ABBV-722, combined with Midazolam and the other drugs, to evaluate how ABBV-722 influences the pharmacokinetics of these medications over time. Participants will be monitored through blood tests to measure drug concentrations and other parameters such as maximum plasma concentration, time to peak concentration, and elimination rates. Adverse events will be recorded for up to 56 days. Overall, the study involves careful observation of drug levels and safety in healthy adults aged 18 to 65, with the trial ending in July 2026.
CONDITIONS
Brief Title
A Phase 1 Study to Assess the Effect of ABBV-722 on Midazolam, Digoxin, Pitavastatin, Metformin, and Sitagliptin Drug Levels in Healthy Adults.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Laboratory values meet the criteria specified in the protocol.
- General good health based on medical history, physical examination, vital signs, laboratory profile, and ECG.
- Adults aged 18 to 65 years.
You will not qualify if you...
- History of clinically significant illness, infection, major febrile illness, hospitalization, or surgery within 30 days prior to first study dose.
- Consumption of alcohol, grapefruit products, Seville oranges, starfruit products, or quinine/tonic water within 72 hours before study treatment.
- Use of tobacco or nicotine products within 90 days before first study dose.
- Prior exposure to ABBV-722 within 90 days before first study dose.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 18 days
Participants receive multiple doses of ABBV-722 and single doses of midazolam, digoxin, pitavastatin, metformin, and sitagliptin to assess drug levels and interactions.
Multiple visits during Period 1 and Period 2 according to dosing schedule
Duration - Up to 56 days
Participants are monitored for adverse events and drug effects up to 56 days after treatment.
Periodic visits for monitoring
Trial Site Locations
Total: 1 location
1
Acpru /Id# 282184
Grayslake, Illinois, United States, 60030
Actively Recruiting
Research Team
A
ABBVIE CALL CENTER
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
BASIC_SCIENCE
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here