A First-in-Human Single Ascending Dose, Mass Balance, and Food Effect Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ABBV-1088 in Healthy Adult Subjects
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Healthy Volunteers
- Sponsor
- AbbVie
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Time to Cmax (Tmax) of ABBV-1088
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
This study will assess the single dose safety, tolerability and pharmacokinetic properties of ABBV-1088 in healthy adult participants
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Time to Cmax (Tmax) of ABBV-1088
Time Frame: Up to approximately 11 days
Tmax of ABBV-1088
Maximum Plasma Concentration (Cmax) of ABBV-1088
Time Frame: Up to approximately 11 days
Cmax of ABBV-1088
Area Under the Concentration-Time Curve From Time 0 to Time t (AUCt) of ABBV-1088
Time Frame: Up to approximately 11 days
AUCt of ABBV-1088
Terminal Phase Elimination Half-Life (t1/2) of ABBV-1088
Time Frame: Up to approximately 11 days
Terminal phase elimination half-life of ABBV-1088
Terminal Phase Elimination Rate Constant (Beta) of ABBV-1088
Time Frame: Up to approximately 11 days
Terminal phase elimination rate constant (beta) of ABBV-1088
Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of ABBV-1088
Time Frame: Up to approximately 11 days
AUCinf of ABBV-1088
Number of Participants With Adverse Events (AEs)
Time Frame: 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