A Study to Assess Drug-Drug Interaction Between ABBV-903 and Midazolam in Adult Healthy Volunteers
- Registration Number
- NCT05895266
- Lead Sponsor
- AbbVie
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Part 1: Period 2 Midazolam 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. Part 2: Period 1 Midazolam In Period 1 on Day 1, participants will receive liquid midazolam. Part 2: Period 2 ABBV-903 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. Part 1: Period 1 Midazolam In Period 1 on Day 1, participants will receive liquid midazolam. Part 1: Period 2 ABBV-903 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. Part 2: Period 2 Midazolam 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.
- Primary Outcome Measures
Name Time Method Number of Participants with Adverse Events (AEs) Up to approximately 40 days 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.
Maximum Plasma Concentration (Cmax) of ABBV-903 Up to approximately 40 days Cmax of ABBV-903
Maximum Plasma Concentration (Cmax) of Midazolam Up to approximately 40 days Cmax of midazolam
Maximum Plasma Concentration (Cmax) of 1-OH-Midazolam Up to approximately 40 days Cmax of 1-OH-midazolam
Time to Cmax (Tmax) of ABBV-903 Up to approximately 40 days Tmax of ABBV-903
Time to Cmax (Tmax) of Midazolam Up to approximately 40 days Tmax of midazolam
Terminal Phase Elimination Half-Life (t1/2) of ABBV-903 Up to approximately 40 days Terminal phase elimination half-life of ABBV-903
Terminal Phase Elimination Half-Life (t1/2) of Midazolam Up to approximately 40 days Terminal phase elimination half-life of midazolam
Time to Cmax (Tmax) of 1-OH-Midazolam Up to approximately 40 days Tmax of 1-OH-midazolam
Terminal Phase Elimination Half-Life (t1/2) of 1-OH-Midazolam Up to approximately 40 days Terminal phase elimination half-life of 1-OH-midazolam
Area Under the Concentration-Time Curve From Time 0 to Last Measurable Concentration (AUCt) of ABBV-903 Up to approximately 40 days AUCt of ABBV-903
Area Under the Concentration-Time Curve From Time 0 to Last Measurable Concentration (AUCt) of Midazolam Up to approximately 40 days AUCt of midazolam
Area Under the Concentration-Time Curve From Time 0 to Last Measurable Concentration (AUCt) of 1-OH-Midazolam Up to approximately 40 days AUCt of 1-OH-midazolam
Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of ABBV-903 Up to approximately 40 days AUCinf of ABBV-903
Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of Midazolam Up to approximately 40 days AUCinf of midazolam
Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of 1-OH-Midazolam Up to approximately 40 days AUCinf of 1-OH-midazolam
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Acpru /Id# 254970
🇺🇸Grayslake, Illinois, United States