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

Study Overview
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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.

Official Title
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A Phase 1 Open-Label Drug-Drug Interaction Study Between ABBV-903 and Midazolam

Conditions
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Healthy Volunteer

Intervention / Treatment
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* Drug: ABBV-903
* Drug: Midazolam


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part 1: Period 1<br>In Period 1 on Day 1, participants will receive liquid midazolam. | Drug: Midazolam<br>* Oral Liquid<br>|
| Experimental: Part 1: Period 2<br>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. | Drug: ABBV-903<br>* Oral Tablet<br>Drug: Midazolam<br>* Oral Liquid<br>|
| Experimental: Part 2: Period 1<br>In Period 1 on Day 1, participants will receive liquid midazolam. | Drug: Midazolam<br>* Oral Liquid<br>|
| Experimental: Part 2: Period 2<br>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. | Drug: ABBV-903<br>* Oral Tablet<br>Drug: Midazolam<br>* Oral Liquid<br>|

What is the study measuring?
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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 participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. | Up to approximately 40 days | 
| Maximum Plasma Concentration (Cmax) of ABBV-903 | Cmax of ABBV-903 | Up to approximately 40 days | 
| Maximum Plasma Concentration (Cmax) of Midazolam | Cmax of midazolam | Up to approximately 40 days | 
| Maximum Plasma Concentration (Cmax) of 1-OH-Midazolam | Cmax of 1-OH-midazolam | Up to approximately 40 days | 
| Time to Cmax (Tmax) of ABBV-903 | Tmax of ABBV-903 | Up to approximately 40 days | 
| Time to Cmax (Tmax) of Midazolam | Tmax of midazolam | Up to approximately 40 days | 
| Time to Cmax (Tmax) of 1-OH-Midazolam | Tmax of 1-OH-midazolam | Up to approximately 40 days | 
| Terminal Phase Elimination Half-Life (t1/2) of ABBV-903 | Terminal phase elimination half-life of ABBV-903 | Up to approximately 40 days | 
| Terminal Phase Elimination Half-Life (t1/2) of Midazolam | Terminal phase elimination half-life of midazolam | Up to approximately 40 days | 
| Terminal Phase Elimination Half-Life (t1/2) of 1-OH-Midazolam | Terminal phase elimination half-life of 1-OH-midazolam | Up to approximately 40 days | 
| Area Under the Concentration-Time Curve From Time 0 to Last Measurable Concentration (AUCt) of ABBV-903 | AUCt of ABBV-903 | Up to approximately 40 days | 
| Area Under the Concentration-Time Curve From Time 0 to Last Measurable Concentration (AUCt) of Midazolam | AUCt of midazolam | Up to approximately 40 days | 
| Area Under the Concentration-Time Curve From Time 0 to Last Measurable Concentration (AUCt) of 1-OH-Midazolam | AUCt of 1-OH-midazolam | Up to approximately 40 days | 
| Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of ABBV-903 | AUCinf of ABBV-903 | Up to approximately 40 days | 
| Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of Midazolam | AUCinf of midazolam | Up to approximately 40 days | 
| Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of 1-OH-Midazolam | AUCinf of 1-OH-midazolam | Up to approximately 40 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy Volunteer, ABBV-903, Midazolam