Healthy VolunteerPhase 1NCT07502417
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 testing Ethinyl Estradiol + Levonorgestrel and ABBV-722 in people with Healthy Volunteer, run by AbbVie at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- Ethinyl Estradiol + Levonorgestrel and ABBV-722
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Mar 2026to 2 Jul 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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
- Being tested
- Ethinyl Estradiol + Levonorgestrel, ABBV-722
- Keywords
- Healthy Volunteer, ABBV-722, Ethinyl Estradiol + Levonorgestrel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ethinyl Estradiol + LevonorgestrelDrug
Oral
ABBV-722Drug
Oral
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Ethinyl Estradiol + Levonorgestrel; Drug: ABBV-722 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed Plasma Concentration (Cmax) of Ethinyl Estradiol and Levonorgestrel
Cmax of Ethinyl Estradiol and Levonorgestrel.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to Approximately 82 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2026
- Study start27 Mar 2026
- Primary completion2 Jul 2026
- Study completion2 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07502417
- Sponsor's protocol ID
- M26-248
- Status last verified
- Jul 2026
- First submitted
- 26 Mar 2026
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07502417
- Acronym / sponsor ID
- M26-248
- Conditions
- Healthy Volunteer
- Keywords
- Healthy Volunteer, ABBV-722, Ethinyl Estradiol + Levonorgestrel
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 27 Mar 2026 (actual)
- Primary completion
- 2 Jul 2026 (actual)
- Study completion
- 2 Jul 2026 (actual)
- First posted
- 31 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Period 1 & 2 | Experimental | Drug: Ethinyl Estradiol + Levonorgestrel, Drug: ABBV-722In 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ethinyl Estradiol + LevonorgestrelOral | Drug | Period 1 & 2 |
| ABBV-722Oral | Drug | Period 1 & 2 |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Healthy Volunteer
RecruitingObservational study
Development of Magnetic Resonance Imaging Techniques for Studying Mood and Anxiety Disorders
Mood Disorders, Anxiety Disorders
Not yet recruiting
Positron Emission Tomography and Organ-Specific Changes in Participants Co-Enrolled in NIH Studies of Plasmodium Vivax Controlled Human Malaria Infection
Healthy Volunteer, Malaria
RecruitingPhase 1
A Single Ascending Dose Study of DTI-117 Given Intramuscularly in Healthy Participants.
Healthy Adult
RecruitingObservational study
Collection of Lung Fluid and Tissue Samples for Research
Leukocyte Disorders, Respiratory Tract Diseases
Not yet recruitingPhase 2
Effects of Meal Macronutrients on Postprandial Lipids
Nephrotic Syndrome, Lipodystrophy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ABBVIE INC. study director
AbbVie
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ethinyl Estradiol + Levonorgestrel and ABBV-722 in people with Healthy Volunteer, run by AbbVie at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.