A Study to Assess Multiple Ascending Dose, Drug-Drug Interaction, and Asian Pharmacokinetic Study of ABBV-1088

Last updated: October 29, 2025
Sponsor: AbbVie
Overall Status: Terminated

Phase

1

Condition

N/A

Treatment

ABBV-1088

Itraconazole (ITZ)

Placebo for ABBV-1088

Clinical Study ID

NCT06579300
M24-931
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

This study will assess the safety, tolerability, and pharmacokinetics of ABBV-1088 in healthy adult Western, Han-Chinese and Japanese participants. This study will also assess drug-drug interaction between itraconazole and ABBV-1088 in healthy adult Western participants.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Body Mass Index (BMI) is > = 18.0 to < = 32.0 kg/m^2 after rounded to the tenthsdecimal, at Screening and upon confinement.

  • 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.

  • Part 3 Only: Han Chinese Participant must be first-or second-generation Han Chineseof full Chinese parentage. First-generation participants will have been born inChina to two participants and four grandparents also born in China of full Chinesedescent. Second-generation participants born outside of China must have two parentsand four grandparents born in China of full Chinese descent. Participants mustmaintain a typical Chinese lifestyle, including consuming a typical Chinese diet. OR

  • Japanese Participant must be first-or second-generation Japanese of full Japaneseparentage. First-generation participants will have been born in Japan to two parentsand four grandparents also born in Japan of full Japanese descent. Second-generationparticipants born outside of Japan must have two parents and four grandparents bornin Japan of full Japanese descent. All participants must maintain a typical Japaneselifestyle, including consuming a typical Japanese diet.

Exclusion

Exclusion Criteria:

  • Part 1 (Groups 1-4), Part 2 and Part 3: History of any clinically significantneurological, respiratory (except mild asthma as a child), endocrine, metabolic,renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, orany uncontrolled medical illness.

  • History of suicidal ideation within one year prior to study drug administration asevidenced by answering "yes" to questions 4 or 5 on the suicidal ideation portion ofthe Columbia Suicide Severity Rating Scale (C-SSRS) completed at Screening, or anyhistory of suicide attempts within the last two years.

Study Design

Total Participants: 72
Treatment Group(s): 3
Primary Treatment: ABBV-1088
Phase: 1
Study Start date:
September 04, 2024
Estimated Completion Date:
September 03, 2025

Connect with a study center

  • CenExel ACT- Anaheim Clinical Trials /ID# 276423

    Anaheim, California 92801
    United States

    Site Not Available

  • CenExel ACT- Anaheim Clinical Trials /ID# 276423

    Anaheim 5323810, California 5332921 92801
    United States

    Site Not Available

  • Acpru /Id# 270552

    Grayslake, Illinois 60030
    United States

    Site Not Available

  • Acpru /Id# 270552

    Grayslake 4894465, Illinois 4896861 60030
    United States

    Site Not Available

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