Healthy Volunteers
Conditions
Brief summary
The objective of this study is to evaluate the PK of a tablet formulation of ABBV-722 under fasted conditions and the effect of food on its bioavailability after administration of single doses
Interventions
DRUGABBV-722
Oral Tablet
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
* Laboratory values meet the criteria specified in the protocol. * A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile, and a 12-lead electrocardiogram (ECG).
Exclusion criteria
* History of any clinically significant illness/infection/major febrile illness, hospitalization, or any surgical procedure within 30 days prior to the first dose of study drug. * Consumption of alcohol, grapefruit products, Seville oranges, starfruit products or quinine/tonic water within the 72-hour period prior to study drug administration. * Use of tobacco or nicotine-containing products within 90 days prior to the first dose of study drug. * Prior exposure to ABBV-722 within 90 days prior to the first dose of study drug.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) of ABBV-722 | Up to Day 8 of each period (Period 1 is 9 days and Periods 2 and 3 are 8 days each; 3 periods total) | Maximum observed plasma concentration (Cmax) of ABBV-722 |
| Time to Cmax (Tmax) of ABBV-722 | Up to Day 8 of each period (Period 1 is 9 days and Periods 2 and 3 are 8 days each; 3 periods total) | Time to Cmax (Tmax) of ABBV-722 |
| Terminal Phase Elimination Rate Constant (β) of ABBV-722 | Up to Day 8 of each period (Period 1 is 9 days and Periods 2 and 3 are 8 days each; 3 periods total) | Terminal phase elimination rate constant of ABBV-722 |
| Terminal Phase Elimination Half-Life (t1/2) of ABBV-722 | Up to Day 8 of each period (Period 1 is 9 days and Periods 2 and 3 are 8 days each; 3 periods total) | Terminal phase elimination half-life of ABBV-722 |
| Area Under the Plasma Concentration-Time Curve From Time 0 to Time of Last Measurable Concentration (AUCt) of ABBV-722 | Up to Day 8 of each period (Period 1 is 9 days and Periods 2 and 3 are 8 days each; 3 periods total) | Area under the plasma concentration-time curve from time 0 to the time of last measurable concentration (AUCt) of ABBV-722 |
| Area Under the Plasma Concentration-Time Curve From Time 0 to Infinite Time (AUCinf) of ABBV-722 | Up to Day 8 of each period (Period 1 is 9 days and Periods 2 and 3 are 8 days each; 3 periods total) | Area under the plasma concentration-time curve from time 0 to infinite time (AUCinf) of ABBV-722 |
| Number of Participants with Adverse Events (AEs) | Up to 57 Days | An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. |
Countries
United States
Contacts
STUDY_DIRECTORABBVIE INC.
AbbVie
Outcome results
None listed