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Active, Not Recruiting

NCT Number: NCT07502417

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Healthy Volunteer

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Acpru /Id# 281745

Grayslake, Illinois, 60030, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ethinyl Estradiol + Levonorgestrel

Drug

Oral

ABBV-722

Drug

Oral

Primary outcomes

  1. 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.

  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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 31, 2026
Registry last updated
Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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