Healthy Volunteers
Conditions
Keywords
Healthy Volunteers, ABBV-1088
Brief summary
This study will assess the single dose safety, tolerability and pharmacokinetic properties of ABBV-1088 in healthy adult participants
Interventions
DRUGDrug: ABBV-1088
• Oral Capsule
DRUGDrug: Placebo for ABBV-1088
• Oral Capsule
Sponsors
AbbVie
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 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 cardiac disease, including congenital structural/conduction abnormalities, cardiomyopathy, myocardial infarction, cardiac arrhythmia. * History of or active medical condition(s) or surgical procedure(s) that might affect gastrointestinal motility, pH, or absorption \[e.g., Crohn's disease, chronic GERD, celiac disease, gastroparesis, short bowel syndrome, gastric surgery (except pyloromyotomy for pyloric stenosis during infancy), cholecystectomy, vagotomy, bowel resection, etc.\]. * History of suicidal ideation within one year prior to study drug administration as evidenced by answering yes to questions 4 or 5 on the suicidal ideation portion of the C-SSRS completed at Screening, or any history of suicide attempts within the last two years. * History of any clinically significant neurological, respiratory (except mild asthma as a child), endocrine, metabolic, renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Plasma Concentration (Cmax) of ABBV-1088 | Up to approximately 11 days | Cmax of ABBV-1088 |
| Time to Cmax (Tmax) of ABBV-1088 | Up to approximately 11 days | Tmax of ABBV-1088 |
| Terminal Phase Elimination Rate Constant (Beta) of ABBV-1088 | Up to approximately 11 days | Terminal phase elimination rate constant (beta) of ABBV-1088 |
| Terminal Phase Elimination Half-Life (t1/2) of ABBV-1088 | Up to approximately 11 days | Terminal phase elimination half-life of ABBV-1088 |
| Area Under the Concentration-Time Curve From Time 0 to Time t (AUCt) of ABBV-1088 | Up to approximately 11 days | AUCt of ABBV-1088 |
| Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of ABBV-1088 | Up to approximately 11 days | AUCinf of ABBV-1088 |
| Number of Participants With Adverse Events (AEs) | Up to Day 32 | 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