A Phase 1 Relative Bioavailability and Food Effect Study of ABBV-668 Extended-Release Formulations
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- Terminal Phase Elimination Half-Life (t1/2) of ABBV-668
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
ABBV-668 Regimen A
Participants will receive ABBV-668 Immediate Release (IR) capsules on Day 1 under fasting conditions
Intervention: ABBV-668 IR (Drug)
ABBV-668 Regimen B
Participants will receive ABBV-668 Extended Release (ER) tablets Formulation 1 administered on day 1 under fasting conditions
Intervention: ABBV-668 ER (Drug)
ABBV-668 Regimen C
Participants will receive ABBV-668 Extended Release (ER) tablets Formulation 1 administered on day 1 under fed conditions
Intervention: ABBV-668 ER (Drug)
ABBV-668 Regimen D
Participants will receive ABBV-668 Extended Release (ER) tablets Formulation 2 administered on day 1 under fasting conditions
Intervention: ABBV-668 ER (Drug)
ABBV-668 Regimen E
Participants will receive ABBV-668 Extended Release (ER) tablets Formulation 2 administered on day 1 under fed conditions
Intervention: ABBV-668 ER (Drug)
ABBV-668 Regimen F
Participants will receive ABBV-668 Extended Release (ER) tablets Formulation 3 administered on day 1 under fasting conditions
Intervention: ABBV-668 ER (Drug)
ABBV-668 Regimen G
Participants will receive ABBV-668 Extended Release (ER) tablets Formulation 3 administered on day 1 under fed conditions
Intervention: ABBV-668 ER (Drug)
Outcomes
Primary Outcomes
Terminal Phase Elimination Half-Life (t1/2) of ABBV-668
Time Frame: Up to approximately 47 days
Terminal phase elimination half-life of ABBV-668
Maximum Plasma Concentration (Cmax) of ABBV-668
Time Frame: Up to approximately 47 days
Cmax of ABBV-668
Time to Cmax (Tmax) of ABBV-668
Time Frame: Up to approximately 47 days
Tmax of ABBV-668
Terminal Phase Elimination Rate Constant (Beta) of ABBV-668
Time Frame: Up to approximately 47 days
Terminal phase elimination rate constant (beta) of ABBV-668
Area Under the Concentration-Time Curve From Time 0 to Time t (AUCt) of ABBV-668
Time Frame: Up to approximately 47 days
AUCt of ABBV-668
Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of ABBV-688
Time Frame: Up to approximately 47 days
AUCinf of ABBV-688
Number of Participants With Adverse Events (AEs)
Time Frame: 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
Secondary Outcomes
No secondary outcomes reported