Healthy VolunteersPhase 1NCT07567781

A Phase 1 Study to Assess the Effect of ABBV-722 on Midazolam, Digoxin, Pitavastatin, Metformin, and Sitagliptin Drug Levels in Healthy Adults.

A Phase 1 study testing ABBV-722, Midazolam and Metformin in people with Healthy Volunteers, run by AbbVie at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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 Midazolam, Digoxin, Pitavastatin, Metformin, and Sitagliptin Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers
What is being tested?: ABBV-722, Midazolam and Metformin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: 1 siteUnited States
Study dates: 30 Apr 2026to 21 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
All sexes
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.

United States1 site

Acpru /Id# 282184
Grayslake, Illinois, 60030

Other trials in United States

About this study

Official title: A Phase 1 Study to Evaluate the Effect of Multiple Doses of ABBV-722 on the Pharmacokinetics of Cocktail Probe Substrates of CYP3A and Select Transporters in Healthy Adult Subjects

The objective of this study is to assess the effect of repeated doses of ABBV-722 on the single dose pharmacokinetics (PK) of Midazolam, Digoxin, Pitavastatin, Metformin, and Sitagliptin

Conditions: Healthy Volunteers
Being tested: ABBV-722, Midazolam, Metformin, Digoxin, Pitavastatin
Keywords: Healthy Volunteers

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ABBV-722Drug
Oral Tablet
MidazolamDrug
Oral Solution
MetforminDrug
Oral Tablet
DigoxinDrug
Oral Tablet
PitavastatinDrug
Oral Tablet
SitagliptinDrug
Oral Tablet

Study groups in NCT07567781
Study group	Role	What they receive
Period 1 & 2	Experimental	During Period 1, participants will receive a single dose of midazolam, followed by the co-administration of single doses of selected transporter cocktail substrates. Throughout Period 2, participants will receive a schedule of daily single doses of ABBV-722, a combination of single doses of midazolam and ABBV-722, and single doses of Midazolam, Digoxin, Pitavastatin, Metformin, and Sitagliptin combined with a single dose of ABBV-722. Receives: Drug: ABBV-722; Drug: Midazolam; Drug: Metformin; Drug: Digoxin; Drug: Pitavastatin; Drug: Sitagliptin

What is being measured

The primary outcome is the main question the study is designed to answer.

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 56 Days
Maximum Observed Plasma Concentration (Cmax) of Midazolam, 1-OH Midazolam, Digoxin, Pitavastatin, Sitagliptin, and Metformin.
Maximum Observed Plasma Concentration (Cmax) of Midazolam, 1-OH Midazolam, Digoxin, Pitavastatin, Sitagliptin, and Metformin.
Measured: Up to Day 7 in Period 1 and between Days 13-18 in Period 2
Time to Cmax (Tmax) of Midazolam, 1-OH Midazolam, Digoxin, Pitavastatin, Sitagliptin, and Metformin.
Time to Cmax (Tmax) of Midazolam, 1-OH Midazolam, Digoxin, Pitavastatin, Sitagliptin, and Metformin.
Measured: Up to Day 7 in Period 1 and between Days 13-18 in Period 2
Area Under the Plasma Concentration-Time Curve From Time 0 to Time of Last Measurable Concentration (AUCt) of Midazolam, 1-OH Midazolam, Digoxin, Pitavastatin, Sitagliptin, and Metformin.
Area Under the Plasma Concentration-Time Curve From Time 0 to Time of Last Measurable Concentration (AUCt) of Midazolam, 1-OH Midazolam, Digoxin, Pitavastatin, Sitagliptin, and Metformin.
Measured: Up to Day 7 in Period 1 and between Days 13-18 in Period 2
Terminal Phase Elimination Rate Constant (β) of Midazolam, 1-OH Midazolam, Digoxin, Pitavastatin, Sitagliptin, and Metformin.
Terminal Phase Elimination Rate Constant (β) of Midazolam, 1-OH Midazolam, Digoxin, Pitavastatin, Sitagliptin, and Metformin.
Measured: Up to Day 7 in Period 1 and between Days 13-18 in Period 2
Terminal Phase Elimination Half-Life (t1/2) of Midazolam, 1-OH Midazolam, Digoxin, Pitavastatin, Sitagliptin, and Metformin.
Terminal Phase Elimination Half-Life (t1/2) of Midazolam, 1-OH Midazolam, Digoxin, Pitavastatin, Sitagliptin, and Metformin.
Measured: Up to Day 7 in Period 1 and between Days 13-18 in Period 2

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Apr 202621 Jul 2026

First posted5 May 2026
Study start30 Apr 2026
Primary completion21 Jul 2026
Study completion21 Jul 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Healthy VolunteersStudies 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: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07567781
Sponsor's protocol ID: M25-744
Status last verified: Aug 2026
First submitted: 28 Apr 2026
Last updated: 20 Aug 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1 Study to Evaluate the Effect of Multiple Doses of ABBV-722 on the Pharmacokinetics of Cocktail Probe Substrates of CYP3A and Select Transporters in Healthy Adult Subjects
ClinicalTrials.gov ID: NCT07567781
Acronym / sponsor ID: M25-744
Conditions: Healthy Volunteers
Keywords: Healthy Volunteers
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: AbbVieIndustry (pharma, biotech, devices)
Study start: 30 Apr 2026 (actual)
Primary completion: 21 Jul 2026 (actual)
Study completion: 21 Jul 2026 (actual)
First posted: 5 May 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 Midazolam, Digoxin, Pitavastatin, Metformin, and Sitagliptin

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: ABBV-722, Drug: Midazolam, Drug: Metformin, Drug: Digoxin, Drug: Pitavastatin, Drug: SitagliptinDuring Period 1, participants will receive a single dose of midazolam, followed by the co-administration of single doses of selected transporter cocktail substrates. Throughout Period 2, participants will receive a schedule of daily single doses of ABBV-722, a combination of single doses of midazolam and ABBV-722, and single doses of Midazolam, Digoxin, Pitavastatin, Metformin, and Sitagliptin combined with a single dose of ABBV-722.

Who may qualify

Ages: 18 to 65 years
Sex: All
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
ABBV-722Oral Tablet	Drug	Period 1 & 2
MidazolamOral Solution	Drug	Period 1 & 2
MetforminOral Tablet	Drug	Period 1 & 2
DigoxinOral Tablet	Drug	Period 1 & 2
PitavastatinOral Tablet	Drug	Period 1 & 2
SitagliptinOral Tablet	Drug	Period 1 & 2

Primary outcome

Number of Participants with Adverse Events (AEs)
Time frame: Up to 56 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.
Maximum Observed Plasma Concentration (Cmax) of Midazolam, 1-OH Midazolam, Digoxin, Pitavastatin, Sitagliptin, and Metformin.
Time frame: Up to Day 7 in Period 1 and between Days 13-18 in Period 2
Maximum Observed Plasma Concentration (Cmax) of Midazolam, 1-OH Midazolam, Digoxin, Pitavastatin, Sitagliptin, and Metformin.
Time to Cmax (Tmax) of Midazolam, 1-OH Midazolam, Digoxin, Pitavastatin, Sitagliptin, and Metformin.
Time frame: Up to Day 7 in Period 1 and between Days 13-18 in Period 2
Time to Cmax (Tmax) of Midazolam, 1-OH Midazolam, Digoxin, Pitavastatin, Sitagliptin, and Metformin.
Area Under the Plasma Concentration-Time Curve From Time 0 to Time of Last Measurable Concentration (AUCt) of Midazolam, 1-OH Midazolam, Digoxin, Pitavastatin, Sitagliptin, and Metformin.
Time frame: Up to Day 7 in Period 1 and between Days 13-18 in Period 2
Area Under the Plasma Concentration-Time Curve From Time 0 to Time of Last Measurable Concentration (AUCt) of Midazolam, 1-OH Midazolam, Digoxin, Pitavastatin, Sitagliptin, and Metformin.
Terminal Phase Elimination Rate Constant (β) of Midazolam, 1-OH Midazolam, Digoxin, Pitavastatin, Sitagliptin, and Metformin.
Time frame: Up to Day 7 in Period 1 and between Days 13-18 in Period 2
Terminal Phase Elimination Rate Constant (β) of Midazolam, 1-OH Midazolam, Digoxin, Pitavastatin, Sitagliptin, and Metformin.
Terminal Phase Elimination Half-Life (t1/2) of Midazolam, 1-OH Midazolam, Digoxin, Pitavastatin, Sitagliptin, and Metformin.
Time frame: Up to Day 7 in Period 1 and between Days 13-18 in Period 2
Terminal Phase Elimination Half-Life (t1/2) of Midazolam, 1-OH Midazolam, Digoxin, Pitavastatin, Sitagliptin, and Metformin.

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 20 Aug 2026.
Individual participant dataSharing planned: No

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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 ABBV-722, Midazolam and Metformin in people with Healthy Volunteers, 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 20 Aug 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?

Number of Participants with Adverse Events (AEs) (time frame: Up to 56 Days). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07567781.

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 20 Aug 2026; AzTrials last refreshed its copy on 26 Oct 2026.