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

Phase 1

Completed

• Conditions: Healthy Volunteers

• Registration Number: NCT06414798
• Lead Sponsor: AbbVie

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-05-10
• Study First Submitted QC: 2024-05-10
• Study Start: 2024-05-13
• Study First Posted: 2024-05-16
• Status Verified: 2025-02
• Primary Completion: 2025-02-08
• Study Completion: 2025-02-08
• Last Update Submitted: 2025-02-17
• Last Update Posted: 2025-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Time to Cmax (Tmax) of ABBV-1088	Up to approximately 11 days	Tmax of ABBV-1088
Maximum Plasma Concentration (Cmax) of ABBV-1088	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	Up to approximately 11 days	AUCt 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
Terminal Phase Elimination Rate Constant (Beta) of ABBV-1088	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	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

Trial Locations

Locations (1)

Acpru /Id# 264249; 🇺🇸 Grayslake, Illinois, United States