Clinical trial NCT06414798: A Study to Assess the Safety, Tolerability, and Pharmacokinetics of ABBV-1088 Oral Dose in Healthy Adult Participants.
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Healthy Volunteers
ABBV-1088
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2024-05-16
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This study will assess the single dose safety, tolerability and pharmacokinetic properties of ABBV-1088 in healthy adult participants


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.

Primary outcomes:
measure: Maximum Plasma Concentration (Cmax) of ABBV-1088
timeFrame: Up to approximately 11 days
measure: Time to Cmax (Tmax) of ABBV-1088
timeFrame: Up to approximately 11 days
measure: Terminal Phase Elimination Rate Constant (Beta) of ABBV-1088
timeFrame: Up to approximately 11 days
measure: Terminal Phase Elimination Half-Life (t1/2) of ABBV-1088
timeFrame: Up to approximately 11 days
measure: Area Under the Concentration-Time Curve From Time 0 to Time t (AUCt) of ABBV-1088
timeFrame: Up to approximately 11 days
measure: Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of ABBV-1088
timeFrame: Up to approximately 11 days
measure: Number of Participants With Adverse Events (AEs)
timeFrame: Up to Day 32
Secondary outcomes:
Other outcomes:
Locations:
city: Grayslake
country: United States
facility: Acpru /Id# 264249
state: Illinois
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: