Healthy Volunteers
Conditions
Keywords
ABBV-903, Healthy Volunteers
Brief summary
The objective of this study is to assess the pharmacokinetics (PK), safety, and tolerability of ABBV-903 or placebo in healthy adult Japanese and Han Chinese subjects.
Interventions
DRUGABBV-903
Tablet; oral
Tablet; oral
Sponsors
AbbVie
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
\- Healthy Japanese or Han Chinese male or female; age is between 18 and 65 years, inclusive at the time of screening. * Han Chinese subject must be first-generation Han Chinese of full Chinese parentage residing outside of China. Subjects must maintain a typical Chinese lifestyle, including consuming a typical Chinese diet. OR * Japanese subject must be first- or second generation Japanese of full Japanese parentage. First-generation subjects will have been born in Japan to two parents and four grandparents also born in Japan of full Japanese descent. Second-generation subjects born outside of Japan must have two parents and four grandparents born in Japan of full Japanese descent. All subjects must maintain a typical Japanese lifestyle, including consuming a typical Japanese diet. * Body Mass Index (BMI) is \>= 18.0 to \<= 30.0 kg/m2 after rounding to the tenths decimal, at screening and upon initial confinement. BMI is calculated as weight in kg divided by the square of height measured in meters.
Exclusion criteria
* History of any clinically significant illness/infection/major febrile illness, hospitalization, as determined by the investigator, or any surgical procedure within 30 days prior to the first dose of study drug. * Evidence of dysplasia or history of malignancy (including lymphoma and leukemia) other than successfully treated non-metastatic cutaneous squamous cell, basal cell carcinoma orlocalized carcinoma in situ of the cervix.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum observed plasma concentration (Cmax) of ABBV-903 | Up to Day 4 | Cmax of ABBV-903 will be assessed. |
| Time to Cmax (Tmax) of ABBV-903 | Up to Day 4 | Tmax of ABBV-903 will be assessed. |
| Apparent Terminal Phase Elimination Rate Constant (β) of ABBV-903 | Up to Day 4 | Apparent terminal phase elimination rate constant (β) of ABBV-903 will be assessed. |
| Terminal Phase Elimination Half-life (t1/2) of ABBV-903 | Up to Day 4 | Terminal phase elimination half-life (t1/2) of ABBV-903 will be assessed. |
| Area under the Plasma Concentration-time Curve (AUC) from Time 0 to the Time t (AUC0-t) of ABBV-903 | Up to Day 4 | AUC0-t of ABBV-903 will be assessed. |
| AUC from Time 0 to Infinity (AUC0-inf) of ABBV-903 | Up to Day 4 | AUC0-inf of ABBV-903 will be assessed. |
| Number of Participants with Adverse Events (AEs) | Baseline to Day 34 | 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. |
Countries
United States
Outcome results
None listed