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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-04

Study Completion Date

2025-09-03

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy Volunteer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Part 1: Group 1 ABBV-1088 Dose A

Participants will receive ABBV-1088 dose A for 7 days

Group Type EXPERIMENTAL

ABBV-1088

Intervention Type DRUG

Oral Capsule

Part 1: Group 1 Placebo

Participants will receive placebo for 7 days

Group Type EXPERIMENTAL

Placebo for ABBV-1088

Intervention Type DRUG

Oral Capsule

Part 1: Group 2 ABBV-1088 Dose B

Participants will receive ABBV-1088 dose B for 21 days

Group Type EXPERIMENTAL

ABBV-1088

Intervention Type DRUG

Oral Capsule

Part 1: Group 2 Placebo

Participants will receive placebo for 21 days

Group Type EXPERIMENTAL

Placebo for ABBV-1088

Intervention Type DRUG

Oral Capsule

Part 1: Group 3 ABBV-1088 Dose C

Participants will receive ABBV-1088 dose C for 7 days

Group Type EXPERIMENTAL

ABBV-1088

Intervention Type DRUG

Oral Capsule

Part 1: Group 3 Placebo

Participants will receive placebo for 7 days

Group Type EXPERIMENTAL

Placebo for ABBV-1088

Intervention Type DRUG

Oral Capsule

Part 1: Group 4 ABBV-1088 Dose D

Participants will receive ABBV-1088 dose D for 21 days

Group Type EXPERIMENTAL

ABBV-1088

Intervention Type DRUG

Oral Capsule

Part 1: Group 4 Placebo

Participants will receive placebo for 21 days

Group Type EXPERIMENTAL

Placebo for ABBV-1088

Intervention Type DRUG

Oral Capsule

Part 1: Group 5 ABBV-1088 Dose D

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

Group Type EXPERIMENTAL

ABBV-1088

Intervention Type DRUG

Oral Capsule

Part 1: Group 5 Placebo

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

Group Type EXPERIMENTAL

Placebo for ABBV-1088

Intervention Type DRUG

Oral Capsule

Part 2: Period 1 ABBV-1088 Dose A

Participants will receive ABBV-1088 Dose A on day 1

Group Type EXPERIMENTAL

ABBV-1088

Intervention Type DRUG

Oral Capsule

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

Group Type EXPERIMENTAL

ABBV-1088

Intervention Type DRUG

Oral Capsule

Itraconazole (ITZ)

Intervention Type DRUG

Oral Capsule

Part 3: Group 1 ABBV-1088 Han Chinese Participants

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

Group Type EXPERIMENTAL

ABBV-1088

Intervention Type DRUG

Oral Capsule

Part 3: Group 2 ABBV-1088 Japanese Participants

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

Group Type EXPERIMENTAL

ABBV-1088

Intervention Type DRUG

Oral Capsule

Interventions

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ABBV-1088

Oral Capsule

Intervention Type DRUG

Placebo for ABBV-1088

Oral Capsule

Intervention Type DRUG

Itraconazole (ITZ)

Oral Capsule

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes