Healthy Volunteer
Conditions
Keywords
Healthy Volunteer, ABBV-1088, Itraconazole
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.
Interventions
Sponsors
AbbVie
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Part 1, 2 and 3: Maximum Plasma Concentration (Cmax) of ABBV-1088 | Up to approximately 24 days | Cmax of ABBV-1088 |
| Part 1, 2 and 3: Time to Cmax (Tmax) of ABBV-1088 | Up to approximately 24 days | Tmax of ABBV-1088 |
| Part 1, 2 and 3: Terminal Phase Elimination Rate Constant (Beta) of ABBV-1088 | Up to approximately 24 days | Terminal phase elimination rate constant (beta) of ABBV-1088 |
| Part 1, 2 and 3: Terminal Phase Elimination Half-Life (t1/2) of ABBV-1088 | Up to approximately 24 days | Terminal phase elimination half-life of ABBV-1088 |
| Part 2 and 3: Area Under the Concentration-Time Curve from Time 0 to Time t (AUCt) of ABBV-1088 | Up to approximately 24 days | AUCt of ABBV-1088 |
| Part 2 and 3: Area Under the Concentration-Time Curve from Time 0 to Infinity (AUCinf) of ABBV-1088 | Up to approximately 24 days | AUCinf of ABBV-1088 |
| Number of Participants with Adverse Events (AEs) | Up to approximately 54 days | An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study |
| Part 1: Trough Concentration (Ctrough) of ABBV-1088 | Up to approximately 24 days | Ctrough of of ABBV-1088 |
| Part 1: Area Under the Plasma Concentration-time Curve (AUC) for the First and Final Dose Intervals (AUCtau) | Up to approximately 24 days | The area under the plasma concentration-time curve over a dosing interval of tau (AUCtau). |
Countries
United States
Outcome results
None listed