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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 Sex: 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

More Details

NCT ID: NCT06579300
Status: Terminated
Sponsor: AbbVie