Healthy Volunteer
Conditions
Keywords
Healthy Volunteer, ABBV-903, Midazolam
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.
Interventions
DRUGABBV-903
Oral Tablet
DRUGMidazolam
Oral Liquid
Sponsors
AbbVie
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Terminal Phase Elimination Half-Life (t1/2) of Midazolam | Up to approximately 40 days | Terminal phase elimination half-life of midazolam |
| 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 |
| 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 ABBV-903 | Up to approximately 40 days | Terminal phase elimination half-life of ABBV-903 |
| 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 |
Countries
United States
Outcome results
None listed