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 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

Study Overview

• Status: Recruiting
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: Metformin; Drug: ABBV-722; Drug: Midazolam; Drug: Digoxin; Drug: Pitavastatin; Drug: Sitagliptin

• Study Type: Interventional
• Enrollment (Estimated): 12
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: ABBVIE CALL CENTER; Phone Number: 844-663-3742; Email: abbvieclinicaltrials@abbvie.com

Study Locations

• United States
  • Illinois
    • Grayslake, Illinois, United States, 60030
      • Recruiting
      • Acpru /Id# 282184

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Period 1 & 2; 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.

Drug: Metformin; Oral Tablet; Drug: ABBV-722; Oral Tablet; Drug: Midazolam; Oral Solution; Drug: Digoxin; Oral Tablet; Drug: Pitavastatin; Oral Tablet; Drug: Sitagliptin; Oral Tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 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.	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.	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.	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.	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.	Up to Day 7 in Period 1 and between Days 13-18 in Period 2

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Study record dates

Study Major Dates

• Study Start (Estimated): April 30, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: April 28, 2026
• First Submitted That Met QC Criteria: April 28, 2026
• First Posted (Actual): May 5, 2026

Study Record Updates

• Last Update Posted (Actual): May 5, 2026
• Last Update Submitted That Met QC Criteria: April 28, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Healthy Volunteers
• Additional Relevant MeSH Terms: Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Azoles; Carbohydrates; Polycyclic Compounds; Glycosides; Steroids; Fused-Ring Compounds; Benzazepines; Pyrazines; Biguanides; Guanidines; Amidines; Benzodiazepines; Triazoles; Digitalis Glycosides; Cardenolides; Cardiac Glycosides; Cardanolides; Sitagliptin Phosphate; Midazolam; Digoxin; Metformin; pitavastatin
• Other Study ID Numbers: M25-744

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes