A Phase 1 Study to Assess the Effect of ABBV-722 on Ethinyl Estradiol and Levonorgestrel Drug Levels in Healthy Adult Female Participants

April 24, 2026 updated by: AbbVie

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

The objective of this study is to assess the effect of repeated doses of ABBV-722 on the single dose pharmacokinetics (PK) of ethinyl estradiol and levonorgestrel.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

16

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Illinois
      • Grayslake, Illinois, United States, 60030
        • Recruiting
        • Acpru /Id# 281745

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Period 1 & 2
In Period 1, participants will receive a single dose of ethinyl estradiol and levonorgestrel. In Period 2, participants will receive multiple daily doses of ABBV-722 and a single dose of ethinyl estradiol and levonorgestrel.
Drug: ABBV-722
Oral
Drug: Ethinyl Estradiol + Levonorgestrel
Oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum Observed Plasma Concentration (Cmax) of Ethinyl Estradiol and Levonorgestrel
Time Frame: Up to Day 5 in Period 1 and between Days 14-21 in Period 2
Cmax of Ethinyl Estradiol and Levonorgestrel.
Up to Day 5 in Period 1 and between Days 14-21 in Period 2
Time to Cmax (Tmax) of Ethinyl Estradiol and Levonorgestrel
Time Frame: Up to Day 5 in Period 1 and between Days 14-21 in Period 2
Tmax of Ethinyl Estradiol and Levonorgestrel.
Up to Day 5 in Period 1 and between Days 14-21 in Period 2
Terminal Phase Elimination Rate Constant (β) of Ethinyl Estradiol and Levonorgestrel
Time Frame: Up to Day 5 in Period 1 and between Days 14-21 in Period 2
β of Ethinyl Estradiol and Levonorgestrel.
Up to Day 5 in Period 1 and between Days 14-21 in Period 2
Terminal Phase Elimination Half-Life (t1/2) of Ethinyl Estradiol and Levonorgestrel
Time Frame: Up to Day 5 in Period 1 and between Days 14-21 in Period 2
t1/2 of Ethinyl Estradiol and Levonorgestrel.
Up to Day 5 in Period 1 and between Days 14-21 in Period 2
Area Under the Plasma Concentration-Time Curve From Time 0 to Time of Last Measurable Concentration (AUCt) of Ethinyl Estradiol and Levonorgestrel
Time Frame: Up to Day 5 in Period 1 and between Days 14-21 in Period 2
AUCt of Ethinyl Estradiol and Levonorgestrel.
Up to Day 5 in Period 1 and between Days 14-21 in Period 2
Area Under the Plasma Concentration-Time Curve From Time 0 to Infinite Time (AUCinf) of Ethinyl Estradiol and Levonorgestrel
Time Frame: Up to Day 5 in Period 1 and between Days 14-21 in Period 2
AUCinf of Ethinyl Estradiol and Levonorgestrel.
Up to Day 5 in Period 1 and between Days 14-21 in Period 2
Number of Participants with Adverse Events (AEs)
Time Frame: Up to Approximately 82 Days
An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
Up to Approximately 82 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Investigators

  • Study Director: ABBVIE INC., AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 27, 2026

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

March 26, 2026

First Submitted That Met QC Criteria

March 26, 2026

First Posted (Actual)

March 31, 2026

Study Record Updates

Last Update Posted (Actual)

April 28, 2026

Last Update Submitted That Met QC Criteria

April 24, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M26-248

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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