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

A First-in-Human Single Ascending Dose and Mass Balance Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ABBV-1088 in Healthy Adult Subjects

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

Study Overview

• Status: Recruiting
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: Drug: ABBV-1088; Drug: Drug: Placebo for ABBV-1088

• Study Type: Interventional
• Enrollment (Estimated): 48
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: ABBVIE CALL CENTER; Phone Number: 844-663-3742; Email: abbvieclinicaltrials@abbvie.com

Study Locations

• United States
  • Illinois
    • Grayslake, Illinois, United States, 60030
      • Recruiting
      • Acpru /Id# 264249

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

12

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1- ABBV-1088 Dose A; Participants will receive single dose of ABBV-1088 dose A on day 1	Drug: Drug: ABBV-1088; • Oral Capsule
Experimental: Group 1- Placebo; Participants will receive single dose of placebo day 1	Drug: Drug: Placebo for ABBV-1088; • Oral Capsule
Experimental: Group 2- ABBV-1088 Dose B; Participants will receive single dose of ABBV-1088 dose B on day 1	Drug: Drug: ABBV-1088; • Oral Capsule
Experimental: Group 2- Placebo; Participants will receive single dose of placebo day 1	Drug: Drug: Placebo for ABBV-1088; • Oral Capsule
Experimental: Group 3- ABBV-1088 Dose C; Participants will receive single dose of ABBV-1088 dose C on day 1	Drug: Drug: ABBV-1088; • Oral Capsule
Experimental: Group 3- Placebo; Participants will receive single dose of placebo day 1	Drug: Drug: Placebo for ABBV-1088; • Oral Capsule
Experimental: Group 4- ABBV-1088 Dose D; Participants will receive single dose of ABBV-1088 dose D on day 1	Drug: Drug: ABBV-1088; • Oral Capsule
Experimental: Group 4- Placebo; Participants will receive single dose of placebo day 1	Drug: Drug: Placebo for ABBV-1088; • Oral Capsule
Experimental: Group 5- ABBV-1088 Dose E; Participants will receive single dose of ABBV-1088 dose E on day 1	Drug: Drug: ABBV-1088; • Oral Capsule
Experimental: Group 5- Placebo; Participants will receive single dose of placebo day 1	Drug: Drug: Placebo for ABBV-1088; • Oral Capsule
Experimental: Group 6- ABBV-1088 Dose F; Participants will receive single dose of ABBV-1088 dose F on day 1	Drug: Drug: ABBV-1088; • Oral Capsule
Experimental: Group 6- Placebo; Participants will receive single dose of placebo day 1	Drug: Drug: Placebo for ABBV-1088; • Oral Capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum Plasma Concentration (Cmax) of ABBV-1088	Cmax of ABBV-1088	Up to approximately 11 days
Time to Cmax (Tmax) of ABBV-1088	Tmax of ABBV-1088	Up to approximately 11 days
Terminal Phase Elimination Rate Constant (Beta) of ABBV-1088	Terminal phase elimination rate constant (beta) of ABBV-1088	Up to approximately 11 days
Terminal Phase Elimination Half-Life (t1/2) of ABBV-1088	Terminal phase elimination half-life of ABBV-1088	Up to approximately 11 days
Area Under the Concentration-Time Curve From Time 0 to Time t (AUCt) of ABBV-1088	AUCt of ABBV-1088	Up to approximately 11 days
Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of ABBV-1088	AUCinf of ABBV-1088	Up to approximately 11 days
Number of Participants With Adverse Events (AEs)	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	Up to Day 32

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): May 13, 2024
• Primary Completion (Estimated): November 28, 2024
• Study Completion (Estimated): November 28, 2024

Study Registration Dates

• First Submitted: May 10, 2024
• First Submitted That Met QC Criteria: May 10, 2024
• First Posted (Actual): May 16, 2024

Study Record Updates

• Last Update Posted (Actual): May 21, 2024
• Last Update Submitted That Met QC Criteria: May 20, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Healthy Volunteers; ABBV-1088
• Other Study ID Numbers: M24-929

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No