A Study to Assess Drug-Drug Interaction Between ABBV-903 and Midazolam in Adult Healthy Volunteers

AbbVie

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteer

Treatments: Drug: ABBV-903; Drug: Midazolam

Study type: Interventional

Funder types: Industry

Identifiers

NCT05895266

M24-225

Details and patient eligibility

About

The main objective of this study is to assess the drug-drug interaction and pharmacokinetics of ABBV-903 and Midazolam in healthy adult participants.

Enrollment: 24 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• BMI is ≥ 18.0 to ≤ 32 kg/m2 after rounding to the tenth.
• Negative test result for SARS-CoV-2 infection upon initial confinement
• A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead ECG.

Exclusion criteria

• History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), endocrine, renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness.
• History of diseases aggravated or triggered by ultraviolet radiation and no history of abnormal reaction photosensitivity or photoallergy to sunlight, or artificial source of intense light, especially ultraviolet light.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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24 participants in 4 patient groups

Part 1: Period 1

Experimental group

Description:

In Period 1 on Day 1, participants will receive liquid midazolam.

Treatment:

Drug: Midazolam

Part 1: Period 2

Experimental group

Description:

In Period 2 on Day 1, participants will receive ABBV-903 oral tablets. In Period 2 on Day 10, participants will receive liquid midazolam and ABBV-903 oral tablets. Participants will be followed-up for approximately 30 days.

Treatment:

Drug: Midazolam

Drug: ABBV-903

Part 2: Period 1

Experimental group

Description:

In Period 1 on Day 1, participants will receive liquid midazolam.

Treatment:

Drug: Midazolam

Part 2: Period 2

Experimental group

Description:

In Period 2 on Day 1, participants will receive ABBV-903 oral tablets. In Period 2 on Day 5, participants will receive liquid midazolam and ABBV-903 oral tablets. Participants will be followed-up for approximately 30 days.

Treatment:

Drug: Midazolam

Drug: ABBV-903