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

NCT07567781 | Recruiting Phase 1 FDA Drug

• 1 other identifier: M25-744
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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 Midazolam, Digoxin, Pitavastatin, Metformin, and Sitagliptin

Conditions

Healthy Volunteers

Keywords

Healthy Volunteers

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (1)

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.

Drug: ABBV-722; Drug: Midazolam; Drug: Metformin; Drug: Digoxin; Drug: Pitavastatin; Drug: Sitagliptin

Interventions

ABBV-722 DRUG

Oral Tablet

Period 1 & 2

Midazolam DRUG

Oral Solution

Period 1 & 2

Metformin DRUG

Oral Tablet

Period 1 & 2

Digoxin DRUG

Oral Tablet

Period 1 & 2

Pitavastatin DRUG

Oral Tablet

Period 1 & 2

Sitagliptin DRUG

Oral Tablet

Period 1 & 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (1)

Acpru /Id# 282184

Grayslake, Illinois, 60030, United States

RECRUITING

MeSH Terms

Interventions

Midazolam; Metformin; Digoxin; pitavastatin; Sitagliptin Phosphate

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Biguanides; Guanidines; Amidines; Organic Chemicals; Digitalis Glycosides; Cardenolides; Cardiac Glycosides; Cardanolides; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Glycosides; Carbohydrates; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Pyrazines

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Central Study Contacts

ABBVIE CALL CENTER

CONTACT

844-663-3742; abbvieclinicaltrials@abbvie.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2026
• First Posted: May 5, 2026
• Study Start: April 30, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)