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

Purpose

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.

Condition

Healthy Volunteer

Eligibility

Eligible Ages: Over 18 Years
Eligible Genders: All
Accepts Healthy Volunteers: Yes

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 Design

Phase: Phase 1
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Basic Science
Masking: Triple (Participant, Investigator, Outcomes Assessor)

Arm Groups

Arm	Description	Assigned Intervention
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

Recruiting Locations

CenExel ACT- Anaheim Clinical Trials /ID# 276423
Anaheim, California 92801

Acpru /Id# 270552
Grayslake, Illinois 60030

More Details

NCT ID: NCT06579300
Status: Recruiting
Sponsor: AbbVie

Study Contact

ABBVIE CALL CENTER
844-663-3742
abbvieclinicaltrials@abbvie.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.