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

AbbVie

Status and phase: Terminated; Phase 1

Conditions: Healthy Volunteer

Treatments: Drug: ABBV-1088; Drug: Placebo for ABBV-1088; Drug: Itraconazole (ITZ)

Study type: Interventional

Funder types: Industry

Identifiers

NCT06579300

M24-931

Details and patient eligibility

About

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.

Enrollment: 72 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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72 participants in 14 patient groups

Part 1: Group 1 ABBV-1088 Dose A

Experimental group

Description:

Participants will receive ABBV-1088 dose A for 7 days

Treatment:

Drug: ABBV-1088

Part 1: Group 1 Placebo

Experimental group

Description:

Participants will receive placebo for 7 days

Treatment:

Drug: Placebo for ABBV-1088

Part 1: Group 2 ABBV-1088 Dose B

Experimental group

Description:

Participants will receive ABBV-1088 dose B for 21 days

Treatment:

Drug: ABBV-1088

Part 1: Group 2 Placebo

Experimental group

Description:

Participants will receive placebo for 21 days

Treatment:

Drug: Placebo for ABBV-1088

Part 1: Group 3 ABBV-1088 Dose C

Experimental group

Description:

Participants will receive ABBV-1088 dose C for 7 days

Treatment:

Drug: ABBV-1088

Part 1: Group 3 Placebo

Experimental group

Description:

Participants will receive placebo for 7 days

Treatment:

Drug: Placebo for ABBV-1088

Part 1: Group 4 ABBV-1088 Dose D

Experimental group

Description:

Participants will receive ABBV-1088 dose D for 21 days

Treatment:

Drug: ABBV-1088

Part 1: Group 4 Placebo

Experimental group

Description:

Participants will receive placebo for 21 days

Treatment:

Drug: Placebo for ABBV-1088

Part 1: Group 5 ABBV-1088 Dose D

Experimental group

Description:

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

Treatment:

Drug: ABBV-1088

Part 1: Group 5 Placebo

Experimental group

Description:

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

Treatment:

Drug: Placebo for ABBV-1088

Part 2: Period 1 ABBV-1088 Dose A

Experimental group

Description:

Participants will receive ABBV-1088 Dose A on day 1

Treatment:

Drug: ABBV-1088

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

Experimental group

Description:

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

Treatment:

Drug: Itraconazole (ITZ)

Drug: ABBV-1088

Part 3: Group 1 ABBV-1088 Han Chinese Participants

Experimental group

Description:

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

Treatment:

Drug: ABBV-1088

Part 3: Group 2 ABBV-1088 Japanese Participants

Experimental group

Description:

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

Treatment:

Drug: ABBV-1088