A Study to Assess Pharmacokinetics, Safety, and Tolerability of ABBV-903 in Healthy Japanese and Han Chinese Participants

Study Overview
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Brief Summary
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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.

Official Title
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A Study to Evaluate Pharmacokinetics, Safety, and Tolerability of ABBV-903 in Healthy Japanese and Han Chinese Subjects

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: ABBV-903
* Drug: Placebo for ABBV-903


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part 1: Han-Chinese Participants ABBV-903<br>Han-Chinese participants will receive a single dose of ABBV-903. | Drug: ABBV-903<br>* Tablet; oral<br>|
| Experimental: Part 1: Japanese Participants ABBV-903<br>Japanese participants will receive a single dose of ABBV-903. | Drug: ABBV-903<br>* Tablet; oral<br>|
| Experimental: Part 1: Placebo<br>Participants will receive a single dose of Placebo for ABBV-903. | Drug: Placebo for ABBV-903<br>* Tablet; oral<br>|
| Experimental: Part 2: Japanese Participants ABBV-903<br>Japanese participants will receive ABBV-903 daily for 10 days. | Drug: ABBV-903<br>* Tablet; oral<br>|
| Experimental: Part 2: Japanese Participants Placebo<br>Japanese participants will receive placebo daily for 10 days. | Drug: Placebo for ABBV-903<br>* Tablet; oral<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum observed plasma concentration (Cmax) of ABBV-903 | Cmax of ABBV-903 will be assessed. | Up to Day 4 | 
| Time to Cmax (Tmax) of ABBV-903 | Tmax of ABBV-903 will be assessed. | Up to Day 4 | 
| Apparent Terminal Phase Elimination Rate Constant (β) of ABBV-903 | Apparent terminal phase elimination rate constant (β) of ABBV-903 will be assessed. | Up to Day 4 | 
| Terminal Phase Elimination Half-life (t1/2) of ABBV-903 | Terminal phase elimination half-life (t1/2) of ABBV-903 will be assessed. | Up to Day 4 | 
| Area under the Plasma Concentration-time Curve (AUC) from Time 0 to the Time t (AUC0-t) of ABBV-903 | AUC0-t of ABBV-903 will be assessed. | Up to Day 4 | 
| AUC from Time 0 to Infinity (AUC0-inf) of ABBV-903 | AUC0-inf of ABBV-903 will be assessed. | Up to Day 4 | 
| Number of Participants with Adverse Events (AEs) | 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. | Baseline to Day 34 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ABBV-903, Healthy Volunteers