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

NCT07502417 | Recruiting Phase 1 FDA Drug

• 1 other identifier: M26-248
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Volunteer

Keywords

Healthy Volunteer; ABBV-722; Ethinyl Estradiol + Levonorgestrel

Outcome Measures

Primary Outcomes (7)

• Maximum Observed Plasma Concentration (Cmax) of Ethinyl Estradiol and Levonorgestrel

  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

  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

  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

  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

  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

  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)

  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

Study Arms (1)

Period 1 & 2

EXPERIMENTAL

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: Ethinyl Estradiol + Levonorgestrel; Drug: ABBV-722

Interventions

Ethinyl Estradiol + Levonorgestrel DRUG

Oral

Period 1 & 2

ABBV-722 DRUG

Oral

Period 1 & 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (1)

Acpru /Id# 281745

Grayslake, Illinois, 60030, United States

RECRUITING

Related Links

• Related Info

MeSH Terms

Interventions

Ethinyl Estradiol-Norgestrel Combination

Intervention Hierarchy (Ancestors)

Ethinyl Estradiol; Norpregnatrienes; Norpregnanes; Norsteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Norgestrel; Norpregnenes; Estrogenic Steroids, Alkylated; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Central Study Contacts

ABBVIE CALL CENTER

CONTACT

844-663-3742; abbvieclinicaltrials@abbvie.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2026
• First Posted: March 31, 2026
• Study Start: March 27, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)