Clinical trial NCT06579300: A Study to Assess Multiple Ascending Dose, Drug-Drug Interaction, and Asian Pharmacokinetic Study of ABBV-1088
Official title: A Phase 1 Multiple Ascending Dose, Drug-Drug Interaction, and Asian Pharmacokinetic Study of ABBV-1088
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Healthy Volunteer
Keywords: Healthy Volunteer
ABBV-1088
Itraconazole
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2024-08-30
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Part 1, 2 and 3: Maximum Plasma Concentration (Cmax) of ABBV-1088
timeFrame: Up to approximately 24 days
measure: Part 1, 2 and 3: Time to Cmax (Tmax) of ABBV-1088
timeFrame: Up to approximately 24 days
measure: Part 1, 2 and 3: Terminal Phase Elimination Rate Constant (Beta) of ABBV-1088
timeFrame: Up to approximately 24 days
measure: Part 1, 2 and 3: Terminal Phase Elimination Half-Life (t1/2) of ABBV-1088
timeFrame: Up to approximately 24 days
measure: Part 2 and 3: Area Under the Concentration-Time Curve from Time 0 to Time t (AUCt) of ABBV-1088
timeFrame: Up to approximately 24 days
measure: Part 2 and 3: Area Under the Concentration-Time Curve from Time 0 to Infinity (AUCinf) of ABBV-1088
timeFrame: Up to approximately 24 days
measure: Number of Participants with Adverse Events (AEs)
timeFrame: Up to approximately 54 days
measure: Part 1: Trough Concentration (Ctrough) of ABBV-1088
timeFrame: Up to approximately 24 days
measure: Part 1: Area Under the Plasma Concentration-time Curve (AUC) for the First and Final Dose Intervals (AUCtau)
timeFrame: Up to approximately 24 days
Secondary outcomes:
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: CenExel ACT- Anaheim Clinical Trials /ID# 276423
state: California
city: Grayslake
country: United States
facility: Acpru /Id# 270552
state: Illinois
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: