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

NCT06579300 | Terminated Phase 1

• 1 other identifier: M24-931
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Healthy Volunteer

Keywords

Healthy Volunteer; ABBV-1088; Itraconazole

Outcome Measures

Primary Outcomes (9)

• Part 1, 2 and 3: Maximum Plasma Concentration (Cmax) of ABBV-1088

  Cmax of ABBV-1088

  Up to approximately 24 days

• Part 1, 2 and 3: Time to Cmax (Tmax) of ABBV-1088

  Tmax of ABBV-1088

  Up to approximately 24 days

• Part 1, 2 and 3: Terminal Phase Elimination Rate Constant (Beta) of ABBV-1088

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

  Up to approximately 24 days

• Part 1, 2 and 3: Terminal Phase Elimination Half-Life (t1/2) of ABBV-1088

  Terminal phase elimination half-life of ABBV-1088

  Up to approximately 24 days

• Part 2 and 3: Area Under the Concentration-Time Curve from Time 0 to Time t (AUCt) of ABBV-1088

  AUCt of ABBV-1088

  Up to approximately 24 days

• Part 2 and 3: Area Under the Concentration-Time Curve from Time 0 to Infinity (AUCinf) of ABBV-1088

  AUCinf of ABBV-1088

  Up to approximately 24 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 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 approximately 54 days

• Part 1: Trough Concentration (Ctrough) of ABBV-1088

  Ctrough of of ABBV-1088

  Up to approximately 24 days

• Part 1: Area Under the Plasma Concentration-time Curve (AUC) for the First and Final Dose Intervals (AUCtau)

  The area under the plasma concentration-time curve over a dosing interval of tau (AUCtau).

  Up to approximately 24 days

Study Arms (14)

Part 1: Group 1 ABBV-1088 Dose A

EXPERIMENTAL

Participants will receive ABBV-1088 dose A for 7 days

Drug: ABBV-1088

Part 1: Group 1 Placebo

EXPERIMENTAL

Participants will receive placebo for 7 days

Drug: Placebo for ABBV-1088

Part 1: Group 2 ABBV-1088 Dose B

EXPERIMENTAL

Participants will receive ABBV-1088 dose B for 21 days

Drug: ABBV-1088

Part 1: Group 2 Placebo

EXPERIMENTAL

Participants will receive placebo for 21 days

Drug: Placebo for ABBV-1088

Part 1: Group 3 ABBV-1088 Dose C

EXPERIMENTAL

Participants will receive ABBV-1088 dose C for 7 days

Drug: ABBV-1088

Part 1: Group 3 Placebo

EXPERIMENTAL

Participants will receive placebo for 7 days

Drug: Placebo for ABBV-1088

Part 1: Group 4 ABBV-1088 Dose D

EXPERIMENTAL

Participants will receive ABBV-1088 dose D for 21 days

Drug: ABBV-1088

Part 1: Group 4 Placebo

EXPERIMENTAL

Participants will receive placebo for 21 days

Drug: Placebo for ABBV-1088

Part 1: Group 5 ABBV-1088 Dose D

EXPERIMENTAL

Participants older than 60 years of age will receive ABBV-1088 dose D for 21 days

Drug: ABBV-1088

Part 1: Group 5 Placebo

EXPERIMENTAL

Participants older than 60 years of age will receive placebo for 21 days

Drug: Placebo for ABBV-1088

Part 2: Period 1 ABBV-1088 Dose A

EXPERIMENTAL

Participants will receive ABBV-1088 Dose A on day 1

Drug: ABBV-1088

Part 2: Period 2 ABBV-1088 Dose A with ITZ

EXPERIMENTAL

Participants will receive ABBV-1088 dose A on day 4 with itraconazole (ITZ) for 10 days

Drug: ABBV-1088; Drug: Itraconazole (ITZ)

Part 3: Group 1 ABBV-1088 Han Chinese Participants

EXPERIMENTAL

Han Chinese participants will receive ABBV-1088 dose E on day 1

Drug: ABBV-1088

Part 3: Group 2 ABBV-1088 Japanese Participants

EXPERIMENTAL

Japanese participants will receive ABBV-1088 dose E on day 1

Drug: ABBV-1088

Interventions

ABBV-1088 DRUG

Oral Capsule

Part 1: Group 1 ABBV-1088 Dose A; Part 1: Group 2 ABBV-1088 Dose B; Part 1: Group 3 ABBV-1088 Dose C; Part 1: Group 4 ABBV-1088 Dose D; Part 1: Group 5 ABBV-1088 Dose D; Part 2: Period 1 ABBV-1088 Dose A; Part 2: Period 2 ABBV-1088 Dose A with ITZ; Part 3: Group 1 ABBV-1088 Han Chinese Participants; Part 3: Group 2 ABBV-1088 Japanese Participants

Placebo for ABBV-1088 DRUG

Oral Capsule

Part 1: Group 1 Placebo; Part 1: Group 2 Placebo; Part 1: Group 3 Placebo; Part 1: Group 4 Placebo; Part 1: Group 5 Placebo

Itraconazole (ITZ) DRUG

Oral Capsule

Part 2: Period 2 ABBV-1088 Dose A with ITZ

Eligibility Criteria

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

You may qualify if:

• Body Mass Index (BMI) is \> = 18.0 to \< = 32.0 kg/m\^2 after rounded to the tenths decimal, 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 Chinese of full Chinese parentage. First-generation participants will have been born in China to two participants and four grandparents also born in China of full Chinese descent. Second-generation participants born outside of China must have two parents and four grandparents born in China of full Chinese descent. Participants must maintain a typical Chinese lifestyle, including consuming a typical Chinese diet. OR
• Japanese Participant must be first-or second-generation Japanese of full Japanese parentage. First-generation participants will have been born in Japan to two parents and four grandparents also born in Japan of full Japanese descent. Second-generation participants born outside of Japan must have two parents and four grandparents born in Japan of full Japanese descent. All participants must maintain a typical Japanese lifestyle, including consuming a typical Japanese diet.

You may not qualify if:

• Part 1 (Groups 1-4), Part 2 and Part 3: 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.
• 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 Columbia Suicide Severity Rating Scale (C-SSRS) completed at Screening, or any history of suicide attempts within the last two years.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (2)

CenExel ACT- Anaheim Clinical Trials /ID# 276423

Anaheim, California, 92801, United States

Location

Acpru /Id# 270552

Grayslake, Illinois, 60030, United States

Location

Related Links

• Related Info

MeSH Terms

Interventions

Itraconazole

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines

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: August 28, 2024
• First Posted: August 30, 2024
• Study Start: September 4, 2024
• Primary Completion: September 3, 2025
• Study Completion: September 3, 2025
• Last Updated: October 30, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)