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

A Phase 1 Multiple Ascending Dose, Drug-Drug Interaction, and Asian Pharmacokinetic Study of ABBV-1088

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.

Study Overview

• Status: Terminated
• Conditions: Healthy Volunteer
• Intervention / Treatment: Drug: ABBV-1088; Drug: Placebo for ABBV-1088; Drug: Itraconazole (ITZ)

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Anaheim, California, United States, 92801
      • CenExel ACT- Anaheim Clinical Trials /ID# 276423
  • Illinois
    • Grayslake, Illinois, United States, 60030
      • Acpru /Id# 270552

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

14

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 1: Group 1 ABBV-1088 Dose A; Participants will receive ABBV-1088 dose A for 7 days	Drug: ABBV-1088; Oral Capsule
Experimental: Part 1: Group 1 Placebo; Participants will receive placebo for 7 days	Drug: Placebo for ABBV-1088; Oral Capsule
Experimental: Part 1: Group 2 ABBV-1088 Dose B; Participants will receive ABBV-1088 dose B for 21 days	Drug: ABBV-1088; Oral Capsule
Experimental: Part 1: Group 2 Placebo; Participants will receive placebo for 21 days	Drug: Placebo for ABBV-1088; Oral Capsule
Experimental: Part 1: Group 3 ABBV-1088 Dose C; Participants will receive ABBV-1088 dose C for 7 days	Drug: ABBV-1088; Oral Capsule
Experimental: Part 1: Group 3 Placebo; Participants will receive placebo for 7 days	Drug: Placebo for ABBV-1088; Oral Capsule
Experimental: Part 1: Group 4 ABBV-1088 Dose D; Participants will receive ABBV-1088 dose D for 21 days	Drug: ABBV-1088; Oral Capsule
Experimental: Part 1: Group 4 Placebo; Participants will receive placebo for 21 days	Drug: Placebo for ABBV-1088; Oral Capsule
Experimental: Part 1: Group 5 ABBV-1088 Dose D; Participants older than 60 years of age will receive ABBV-1088 dose D for 21 days	Drug: ABBV-1088; Oral Capsule
Experimental: Part 1: Group 5 Placebo; Participants older than 60 years of age will receive placebo for 21 days	Drug: Placebo for ABBV-1088; Oral Capsule
Experimental: Part 2: Period 1 ABBV-1088 Dose A; Participants will receive ABBV-1088 Dose A on day 1	Drug: ABBV-1088; Oral Capsule
Experimental: Part 2: Period 2 ABBV-1088 Dose A with ITZ; Participants will receive ABBV-1088 dose A on day 4 with itraconazole (ITZ) for 10 days	Drug: ABBV-1088; Oral Capsule; Drug: Itraconazole (ITZ); Oral Capsule
Experimental: Part 3: Group 1 ABBV-1088 Han Chinese Participants; Han Chinese participants will receive ABBV-1088 dose E on day 1	Drug: ABBV-1088; Oral Capsule
Experimental: Part 3: Group 2 ABBV-1088 Japanese Participants; Japanese participants will receive ABBV-1088 dose E on day 1	Drug: ABBV-1088; Oral Capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

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): September 4, 2024
• Primary Completion (Actual): September 3, 2025
• Study Completion (Actual): September 3, 2025

Study Registration Dates

• First Submitted: August 28, 2024
• First Submitted That Met QC Criteria: August 28, 2024
• First Posted (Actual): August 30, 2024

Study Record Updates

• Last Update Posted (Estimated): October 30, 2025
• Last Update Submitted That Met QC Criteria: October 29, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Healthy Volunteer; Itraconazole; ABBV-1088
• Additional Relevant MeSH Terms: Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Azoles; Triazoles; Piperazines; Itraconazole
• Other Study ID Numbers: M24-931

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