Actively Recruiting
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
Led by AbbVie · Updated on 2026-04-28
16
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating how repeated doses of ABBV-722 affect the levels of ethinyl estradiol and levonorgestrel, which are components of a combined oral contraceptive, in healthy adult female participants. This Phase 1 study aims to understand the drug interactions and pharmacokinetics to ensure safe and effective use. The study is sponsored by AbbVie and involves healthy volunteers aged 18 to 65 years. The study consists of two periods. In Period 1, participants receive a single dose of ethinyl estradiol and levonorgestrel to establish baseline drug levels. In Period 2, participants take multiple daily doses of ABBV-722 alongside a single dose of ethinyl estradiol and levonorgestrel to observe how ABBV-722 influences the pharmacokinetics of the contraceptive drugs. Participants will be monitored for various pharmacokinetic measures such as maximum plasma concentration, time to maximum concentration, elimination rate, half-life, and plasma concentration over time for both ethinyl estradiol and levonorgestrel. Safety is assessed by tracking adverse events for up to approximately 82 days. The study involves medical history review, physical exams, laboratory tests, vital signs, and ECGs to ensure participant health throughout the trial.
CONDITIONS
Brief Title
A Phase 1 Study to Assess the Effect of ABBV-722 on Ethinyl Estradiol and Levonorgestrel Drug Levels in Healthy Adult Female Participants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Laboratory values meet the criteria specified in the protocol.
- Participants are in general good health based on medical history, physical exam, vital signs, lab tests, and ECG.
- Female participants aged 18 to 65 years.
You will not qualify if you...
- History of any significant illness, infection, major fever, hospitalization, or surgery within 30 days before the first dose.
- Consumption of alcohol, grapefruit, Seville oranges, starfruit, or quinine/tonic water within 72 hours prior to study treatment.
- Use of tobacco or nicotine products within 3 months before the first dose.
- Prior exposure to ABBV-722 within 90 days before the first dose of study treatment.
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.
Duration - Up to 5 days
Participants receive a single dose of ethinyl estradiol and levonorgestrel to assess initial drug levels.
1 visit for dosing and assessments
Duration - Between Days 14 and 21
Participants receive multiple daily doses of ABBV-722 along with a single dose of ethinyl estradiol and levonorgestrel to assess drug interactions.
Multiple visits during dosing and assessments
Trial Site Locations
Total: 1 location
1
Acpru /Id# 281745
Grayslake, Illinois, United States, 60030
Actively Recruiting
Research Team
A
ABBVIE CALL CENTER
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
BASIC_SCIENCE
Number of Arms
1
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