How ABBV-722 affects levels of common medicines in healthy adults
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
This trial tests whether taking ABBV-722 changes blood levels of five commonly used drugs in healthy adults.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | AbbVie Industry-sponsored |
| Locations | 1 site (Grayslake, Illinois) |
| Trial ID | NCT07567781 on ClinicalTrials.gov |
What this trial studies
In this Phase 1, interventional study, healthy adult volunteers receive repeated doses of ABBV-722 and then single doses of five probe medications (midazolam, digoxin, pitavastatin, metformin, and sitagliptin) to measure changes in drug concentration over time. Blood samples are collected at scheduled times to characterize pharmacokinetics before and after ABBV-722 exposure. Participants undergo routine safety monitoring including labs, vital signs, and ECGs during the study. The goal is to determine whether ABBV-722 alters the metabolism or clearance of these representative drugs.
Who should consider this trial
Good fit: Healthy adults who meet the protocol's laboratory, ECG, and medical history criteria, have no recent significant illness or surgery, have not used tobacco or nicotine for 90 days, and have had no ABBV-722 exposure within 90 days are eligible.
Not a fit: People with chronic health conditions or those taking regular prescription medications are unlikely to benefit because the study enrolls healthy volunteers and focuses on single-dose interaction testing.
Why it matters
Potential benefit: If successful, the results could help clinicians understand potential drug interactions with ABBV-722 and guide safer co-prescribing.
How similar studies have performed: Drug–drug interaction studies using probe drugs are a common and successful approach to identify how new therapies affect the blood levels of other medications, although ABBV-722-specific results are not widely available yet.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Laboratory values meet the criteria specified in the protocol. * A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile, and a 12-lead electrocardiogram (ECG). Exclusion Criteria: * History of any clinically significant illness/infection/major febrile illness, hospitalization, or any surgical procedure within 30 days prior to the first dose of study treatment. * Consumption of alcohol, grapefruit products, Seville oranges, starfruit products or quinine/tonic water within the 72-hour period prior to study treatment administration. * Use of tobacco- or nicotine-containing products within 3 months (90 days) prior to the first dose of study treatment. * Participant has prior exposure to ABBV-722 within 90 days prior to the first dose of study treatment.
Where this trial is running
Grayslake, Illinois
- Acpru /Id# 282184 — Grayslake, Illinois, United States (Recruiting)
Study contacts
- Study coordinator: Abbvie Call Center
- Email: abbvieclinicaltrials@abbvie.com
- Phone: 844-663-3742
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.