A Single and Multiple Dose Study of Dotinurad in Chinese Healthy Participants

Eisai Co., Ltd.26 enrolled

Overview

The primary purpose of this study is to evaluate the pharmacokinetics (PK) of dotinurad following single and multiple oral doses of dotinurad in Chinese healthy male and female participants.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Healthy Volunteers

Interventions

DotinuradDRUG

Dotinurad oral tablet.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

Key Inclusion Criteria: 1. Healthy Chinese participants living in China. 2. Non-smoking, male or female, age greater than or equal to (\>=) 18 years and less than or equal to (\<=) 45 years old at the time of informed consent. 3. Participants with serum uric acid level less than \>=5.5 milligrams per decilitre (mg/dL) at Screening (Cohort B only). Key Exclusion Criteria: 1. Females who are breastfeeding or pregnant at Screening or Baseline (as documented by a positive beta-human chorionic gonadotropin \[β-hCG\] or human chorionic gonadotropin \[hCG\] test). A separate baseline assessment of serum β-hCG (or hCG) or urine pregnancy test is required if a negative screening pregnancy test was obtained more than 72 hours before the first dose of study drug. 2. Females of childbearing potential. 3. Clinically significant illness that requires medical treatment within 8 weeks or a clinically significant infection that requires medical treatment within 4 weeks of dosing. 4. Evidence of disease that may influence the outcome of the study within 4 weeks before dosing; example, psychiatric disorders and disorders of the gastrointestinal tract, liver, kidney, respiratory system, endocrine system, hematological system, neurological system, or cardiovascular system, or participants who have a congenital abnormality in metabolism. 5. Any history of gastrointestinal surgery that may affect PK profiles of dotinurad, example, hepatectomy, nephrectomy, digestive organ resection at Screening.

Locations (1)

Shanghai Xuhui District Central Hospital

Shanghai, China