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Completed

NCT Number: NCT06414798

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

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

Completed

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Key information

Conditions

Healthy Volunteers

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Acpru /Id# 264249

Grayslake, Illinois, 60030, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Drug: ABBV-1088

Drug
  • Oral Capsule

Drug: Placebo for ABBV-1088

Drug
  • Oral Capsule

Primary outcomes

  1. Maximum Plasma Concentration (Cmax) of ABBV-1088

    Time frame: Up to approximately 11 days

    Cmax of ABBV-1088

  2. Time to Cmax (Tmax) of ABBV-1088

    Time frame: Up to approximately 11 days

    Tmax of ABBV-1088

  3. Terminal Phase Elimination Rate Constant (Beta) of ABBV-1088

    Time frame: Up to approximately 11 days

    Terminal phase elimination rate constant (beta) of ABBV-1088

  4. Terminal Phase Elimination Half-Life (t1/2) of ABBV-1088

    Time frame: Up to approximately 11 days

    Terminal phase elimination half-life of ABBV-1088

  5. Area Under the Concentration-Time Curve From Time 0 to Time t (AUCt) of ABBV-1088

    Time frame: Up to approximately 11 days

    AUCt of ABBV-1088

  6. Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of ABBV-1088

    Time frame: Up to approximately 11 days

    AUCinf of ABBV-1088

  7. Number of Participants With Adverse Events (AEs)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 16, 2024
Registry last updated
Feb 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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