Healthy Volunteers
Conditions
Keywords
Healthy Volunteers, ABBV-668
Brief summary
The objectives of this study are to assess safety and tolerability of the new ABBV-668 ER tablets, to assess the oral bioavailability of the ABBV-668 ER tablets relative to the ABBV-668 IR capsules, and to assess the pharmacokinetics of the ER tablets under fasting and fed conditions in healthy adults.
Interventions
DRUGABBV-668 IR
• Oral Capsule
DRUGABBV-668 ER
• Oral Tablets
Sponsors
AbbVie
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* BMI is ≥ 18.0 to ≤ 32.0 kg/m\^2 after rounding to the tenths decimal at screening. * 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 any clinically significant sensitivity or allergy to any medication or food. * History of any investigational drug within 30 days or 5 half-lives of the drug (whichever is longer) prior to the first dose of study drug or is currently enrolled in another clinical study or was previously enrolled in this study. * History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness. * Participant using any medication, vitamins and/or herbal supplements (including traditional Chinese medicine), with the exception of hormonal replacement therapies for females, on a regular basis. * Any use of tobacco or nicotine-containing products within 180 days prior to the first dose of study drug.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Plasma Concentration (Cmax) of ABBV-668 | Up to approximately 47 days | Cmax of ABBV-668 |
| Time to Cmax (Tmax) of ABBV-668 | Up to approximately 47 days | Tmax of ABBV-668 |
| Terminal Phase Elimination Rate Constant (Beta) of ABBV-668 | Up to approximately 47 days | Terminal phase elimination rate constant (beta) of ABBV-668 |
| Terminal Phase Elimination Half-Life (t1/2) of ABBV-668 | Up to approximately 47 days | Terminal phase elimination half-life of ABBV-668 |
| Area Under the Concentration-Time Curve From Time 0 to Time t (AUCt) of ABBV-668 | Up to approximately 47 days | AUCt of ABBV-668 |
| Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of ABBV-688 | Up to approximately 47 days | AUCinf of ABBV-688 |
| Number of Participants With Adverse Events (AEs) | Up to Day 47 | An adverse event (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. The investigator assesses the relationship of each event to the use of study |
Countries
United States
Outcome results
None listed