A Study to Assess the Safety, Tolerability, and Pharmacokinetics of ABBV-1088 Oral Dose in Healthy Adult Participants.

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy Volunteers

In brief

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

Key facts

Study ID

NCT06414798

Run by

AbbVie

People needed

60

Starts

2024-05-13

Expected to finish

2025-02-08

Last updated by the study team

2025-02-19

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Acpru /Id# 264249 — Grayslake, Illinois, United States

Full record on ClinicalTrials.gov

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