Assessing the safety and interaction of ABBV-1088 in healthy volunteers
A Phase 1 Multiple Ascending Dose, Drug-Drug Interaction, and Asian Pharmacokinetic Study of ABBV-1088
This study tests the safety of a new drug called ABBV-1088 in healthy adults from different backgrounds to see how their bodies handle it and how it interacts with another medication.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 66 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | AbbVie Industry-sponsored |
| Locations | 1 site (Grayslake, Illinois) |
| Trial ID | NCT06579300 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety, tolerability, and pharmacokinetics of ABBV-1088 in healthy adult participants from Western, Han-Chinese, and Japanese backgrounds. It includes multiple ascending doses and examines the drug-drug interaction between ABBV-1088 and itraconazole specifically in healthy Western adults. The study aims to gather important data on how these populations metabolize the drug and its interactions with other medications.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy adults aged 18-65 with a BMI between 18.0 and 32.0 kg/m², particularly those of Han-Chinese or Japanese descent.
Not a fit: Patients who do not meet the inclusion criteria, such as those with pre-existing health conditions or outside the specified BMI range, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the safety and effectiveness of ABBV-1088, potentially leading to better treatment options for patients in the future.
How similar studies have performed: While this study focuses on a specific drug and population, similar studies assessing drug interactions and pharmacokinetics have shown promise in enhancing our understanding of medication safety and efficacy.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Grayslake, Illinois
- Acpru /Id# 270552 — Grayslake, Illinois, United States (Recruiting)
Study contacts
- Study coordinator: Abbvie Call Center
- Email: abbvieclinicaltrials@abbvie.com
- Phone: 844-663-3742
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.