Effect of ABBV-722 on ethinyl estradiol and levonorgestrel levels in healthy adult women
A Phase 1 Study to Assess the Effect of Multiple Doses of ABBV-722 on the Pharmacokinetics of a Combined Oral Contraceptive Containing Ethinyl Estradiol and Levonorgestrel
This will test whether repeated doses of ABBV-722 change blood levels of ethinyl estradiol and levonorgestrel in healthy adult female volunteers.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 16 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | Female |
| Sponsor | AbbVie Industry-sponsored |
| Locations | 1 site (Grayslake, Illinois) |
| Trial ID | NCT07502417 on ClinicalTrials.gov |
What this trial studies
This is a Phase 1, open-label pharmacokinetic interaction study in healthy adult female participants. Participants receive a single dose of ethinyl estradiol plus levonorgestrel while also receiving repeated doses of ABBV-722, with blood sampling to measure drug concentrations over time. Safety monitoring includes physical exams, vital signs, laboratory tests, and 12-lead ECGs, and participants must meet specified lab and health criteria. The protocol excludes recent tobacco/nicotine use, recent significant illness or surgery, recent exposure to ABBV-722, and requires avoidance of certain foods and beverages before dosing.
Who should consider this trial
Good fit: Ideal candidates are healthy adult women who meet the protocol's lab, ECG, and medical criteria, are not recent tobacco/nicotine users, and can adhere to pre-visit restrictions and onsite visits in Grayslake, Illinois.
Not a fit: Individuals who are pregnant or breastfeeding, have recent major illness or surgery, use tobacco/nicotine within 90 days, have abnormal screening labs/ECG, or cannot comply with dietary or visit requirements are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, results could clarify whether ABBV-722 affects hormonal contraceptive levels and guide safe coadministration recommendations.
How similar studies have performed: Pharmacokinetic interaction studies between new drugs and oral contraceptives are a common approach to identify meaningful interactions, but the effect of ABBV-722 specifically on these hormones has not been previously established and is being tested here.
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# 281745 — 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.