Clinical trial NCT05895266: A Study to Assess Drug-Drug Interaction Between ABBV-903 and Midazolam in Adult Healthy Volunteers
Official title: A Phase 1 Open-Label Drug-Drug Interaction Study Between ABBV-903 and Midazolam
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Keywords: Healthy Volunteer
ABBV-903
Midazolam
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2023-06-08
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants with Adverse Events (AEs)
timeFrame: Up to approximately 40 days
measure: Maximum Plasma Concentration (Cmax) of ABBV-903
timeFrame: Up to approximately 40 days
measure: Maximum Plasma Concentration (Cmax) of Midazolam
timeFrame: Up to approximately 40 days
measure: Maximum Plasma Concentration (Cmax) of 1-OH-Midazolam
timeFrame: Up to approximately 40 days
measure: Time to Cmax (Tmax) of ABBV-903
timeFrame: Up to approximately 40 days
measure: Time to Cmax (Tmax) of Midazolam
timeFrame: Up to approximately 40 days
measure: Time to Cmax (Tmax) of 1-OH-Midazolam
timeFrame: Up to approximately 40 days
measure: Terminal Phase Elimination Half-Life (t1/2) of ABBV-903
timeFrame: Up to approximately 40 days
measure: Terminal Phase Elimination Half-Life (t1/2) of Midazolam
timeFrame: Up to approximately 40 days
measure: Terminal Phase Elimination Half-Life (t1/2) of 1-OH-Midazolam
timeFrame: Up to approximately 40 days
measure: Area Under the Concentration-Time Curve From Time 0 to Last Measurable Concentration (AUCt) of ABBV-903
timeFrame: Up to approximately 40 days
measure: Area Under the Concentration-Time Curve From Time 0 to Last Measurable Concentration (AUCt) of Midazolam
timeFrame: Up to approximately 40 days
measure: Area Under the Concentration-Time Curve From Time 0 to Last Measurable Concentration (AUCt) of 1-OH-Midazolam
timeFrame: Up to approximately 40 days
measure: Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of ABBV-903
timeFrame: Up to approximately 40 days
measure: Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of Midazolam
timeFrame: Up to approximately 40 days
measure: Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of 1-OH-Midazolam
timeFrame: Up to approximately 40 days
Secondary outcomes:
Other outcomes:
Locations:
city: Grayslake
country: United States
facility: Acpru /Id# 254970
state: Illinois
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: