Status:
TERMINATED
A Study to Assess Multiple Ascending Dose, Drug-Drug Interaction, and Asian Pharmacokinetic Study of ABBV-1088
Lead Sponsor:
AbbVie
Conditions:
Healthy Volunteer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 be...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 4 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 3 2025
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT06579300
Start Date
September 4 2024
End Date
September 3 2025
Last Update
October 30 2025
Active Locations (2)
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1
CenExel ACT- Anaheim Clinical Trials /ID# 276423
Anaheim, California, United States, 92801
2
Acpru /Id# 270552
Grayslake, Illinois, United States, 60030