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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-23

Study Completion Date

2023-11-02

Brief Summary

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

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Detailed Description

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Conditions

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Healthy Volunteer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Part 1: Period 1

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

Group Type EXPERIMENTAL

Midazolam

Intervention Type DRUG

Oral Liquid

Part 1: Period 2

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.

Group Type EXPERIMENTAL

ABBV-903

Intervention Type DRUG

Oral Tablet

Midazolam

Intervention Type DRUG

Oral Liquid

Part 2: Period 1

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

Group Type EXPERIMENTAL

Midazolam

Intervention Type DRUG

Oral Liquid

Part 2: Period 2

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.

Group Type EXPERIMENTAL

ABBV-903

Intervention Type DRUG

Oral Tablet

Midazolam

Intervention Type DRUG

Oral Liquid

Interventions

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ABBV-903

Oral Tablet

Intervention Type DRUG

Midazolam

Oral Liquid

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes