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

NCT06414798 | Completed Phase 1

• 1 other identifier: M24-929
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Volunteers

Keywords

Healthy Volunteers; ABBV-1088

Outcome Measures

Primary Outcomes (7)

• 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

Study Arms (12)

Group 1- ABBV-1088 Dose A

EXPERIMENTAL

Participants will receive single dose of ABBV-1088 dose A on day 1

Drug: Drug: ABBV-1088

Group 1- Placebo

EXPERIMENTAL

Participants will receive single dose of placebo day 1

Drug: Drug: Placebo for ABBV-1088

Group 2- ABBV-1088 Dose B

EXPERIMENTAL

Participants will receive single dose of ABBV-1088 dose B on day 1

Drug: Drug: ABBV-1088

Group 2- Placebo

EXPERIMENTAL

Participants will receive single dose of placebo day 1

Drug: Drug: Placebo for ABBV-1088

Group 3- ABBV-1088 Dose C

EXPERIMENTAL

Participants will receive single dose of ABBV-1088 dose C on day 1

Drug: Drug: ABBV-1088

Group 3- Placebo

EXPERIMENTAL

Participants will receive single dose of placebo day 1

Drug: Drug: Placebo for ABBV-1088

Group 4- ABBV-1088 Dose D

EXPERIMENTAL

Participants will receive single dose of ABBV-1088 dose D on day 1

Drug: Drug: ABBV-1088

Group 4- Placebo

EXPERIMENTAL

Participants will receive single dose of placebo day 1

Drug: Drug: Placebo for ABBV-1088

Group 5- ABBV-1088 Dose E

EXPERIMENTAL

Participants will receive single dose of ABBV-1088 dose E on day 1

Drug: Drug: ABBV-1088

Group 5- Placebo

EXPERIMENTAL

Participants will receive single dose of placebo day 1

Drug: Drug: Placebo for ABBV-1088

Group 6- ABBV-1088 Dose F

EXPERIMENTAL

Participants will receive single dose of ABBV-1088 dose F on day 1

Drug: Drug: ABBV-1088

Group 6- Placebo

EXPERIMENTAL

Participants will receive single dose of placebo day 1

Drug: Drug: Placebo for ABBV-1088

Interventions

Drug: ABBV-1088 DRUG

• Oral Capsule

Group 1- ABBV-1088 Dose A; Group 2- ABBV-1088 Dose B; Group 3- ABBV-1088 Dose C; Group 4- ABBV-1088 Dose D; Group 5- ABBV-1088 Dose E; Group 6- ABBV-1088 Dose F

Drug: Placebo for ABBV-1088 DRUG

• Oral Capsule

Group 1- Placebo; Group 2- Placebo; Group 3- Placebo; Group 4- Placebo; Group 5- Placebo; Group 6- Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (1)

Acpru /Id# 264249

Grayslake, Illinois, 60030, United States

Location

Related Links

• Related Info

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2024
• First Posted: May 16, 2024
• Study Start: May 13, 2024
• Primary Completion: February 8, 2025
• Study Completion: February 8, 2025
• Last Updated: February 19, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)