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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07502417

Enrollment

Registered

2026-03-31

Start date

2026-03-27

Completion date

2026-07-02

Last updated

2026-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteer

Keywords

Healthy Volunteer, ABBV-722, Ethinyl Estradiol + Levonorgestrel

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.

Interventions

DRUGEthinyl Estradiol + Levonorgestrel

Oral

DRUGABBV-722

Oral

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 65 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Maximum Observed Plasma Concentration (Cmax) of Ethinyl Estradiol and Levonorgestrel	Up to Day 5 in Period 1 and between Days 14-21 in Period 2	Cmax of Ethinyl Estradiol and Levonorgestrel.
Time to Cmax (Tmax) of Ethinyl Estradiol and Levonorgestrel	Up to Day 5 in Period 1 and between Days 14-21 in Period 2	Tmax of Ethinyl Estradiol and Levonorgestrel.
Terminal Phase Elimination Rate Constant (β) of Ethinyl Estradiol and Levonorgestrel	Up to Day 5 in Period 1 and between Days 14-21 in Period 2	β of Ethinyl Estradiol and Levonorgestrel.
Terminal Phase Elimination Half-Life (t1/2) of Ethinyl Estradiol and Levonorgestrel	Up to Day 5 in Period 1 and between Days 14-21 in Period 2	t1/2 of Ethinyl Estradiol and Levonorgestrel.
Area Under the Plasma Concentration-Time Curve From Time 0 to Time of Last Measurable Concentration (AUCt) of Ethinyl Estradiol and Levonorgestrel	Up to Day 5 in Period 1 and between Days 14-21 in Period 2	AUCt of Ethinyl Estradiol and Levonorgestrel.
Area Under the Plasma Concentration-Time Curve From Time 0 to Infinite Time (AUCinf) of Ethinyl Estradiol and Levonorgestrel	Up to Day 5 in Period 1 and between Days 14-21 in Period 2	AUCinf of Ethinyl Estradiol and Levonorgestrel.
Number of Participants with Adverse Events (AEs)	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.

Countries

United States

Contacts

STUDY_DIRECTORABBVIE INC.

AbbVie

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 31, 2026