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

Study Overview
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Brief Summary
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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.

Official Title
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A Single and Multiple Dose Pharmacokinetic Study of Dotinurad in Chinese Healthy Subjects

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: Dotinurad


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Healthy Chinese participants living in China. 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. Participants with serum uric acid level less than >=5.5 milligrams per decilitre (mg/dL) at Screening (Cohort B only). Key Exclusion Criteria: 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. Females of childbearing potential. Clinically significant illness that requires medical treatment within 8 weeks or a clinically significant infection that requires medical treatment within 4 weeks of dosing. 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. Any history of gastrointestinal surgery that may affect PK profiles of dotinurad, example, hepatectomy, nephrectomy, digestive organ resection at Screening.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort A Single Dose: Dotinurad<br>Participants will receive dotinurad 1 milligram (mg) (1*1 mg tablet) as a single oral dose after 10-hour fasting on Day 1 in the morning. | Drug: Dotinurad<br>* Dotinurad oral tablet.<br>* Other names: FYU-981;|
| Experimental: Cohort B Multiple Dose: Dotinurad<br>Participants will receive dotinurad 4 mg (2*2 mg tablets) as a single oral dose after 10-hour fasting on Day 1 in the morning. A washout period of 3 days will be maintained after single dose on Day 1 and then participants will receive dotinurad 4 mg (2*2 mg tablets) after 10-hour fasting from Day 4 to Day 10 once daily in the morning. | Drug: Dotinurad<br>* Dotinurad oral tablet.<br>* Other names: FYU-981;|
| Experimental: Cohort C Single Dose: Dotinurad<br>Participants will receive dotinurad 10 mg (5*2 mg tablets) as a single oral dose after 10-hour fasting on Day 1 in the morning. | Drug: Dotinurad<br>* Dotinurad oral tablet.<br>* Other names: FYU-981;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Single-dose Part, Cmax: Maximum Observed Concentration for Dotinurad |  | Day 1: 0-48 hours post dose | 
| Single-dose Part, Tmax: Time at Which the Highest Drug Concentration Occurs for Dotinurad |  | Day 1: 0-48 hours post dose | 
| Single-dose Part, t1/2: Terminal Elimination Phase Half-life for Dotinurad |  | Day 1: 0-48 hours post dose | 
| Single-dose Part, AUC0-t: Area Under the Concentration-time Curve From Zero Time to Time of Last Quantifiable Concentration for Dotinurad |  | Day 1: 0-48 hours post dose | 
| Single-dose Part, AUC0-24h: Area Under the Concentration-time Curve From Zero Time to 24 hours for Dotinurad |  | Day 1: 0-24 hours post dose | 
| Single-dose Part, AUC0-inf: Area Under the Concentration-time Curve From Zero Time Extrapolated to Infinite Time for Dotinurad |  | Day 1: 0-48 hours post dose | 
| Single-dose Part, CL/F: Apparent Total Clearance Following Oral Administration for Dotinurad |  | Day 1: 0-48 hours post dose | 
| Single-dose Part, Vz/F: Apparent Volume of Distribution at Terminal Phase for Dotinurad |  | Day 1: 0-48 hours post dose | 
| Single-dose Part, kel: Elimination Rate Constant for Dotinurad |  | Day 1: 0-48 hours post dose | 
| Single-dose Part, MRT0-t: Mean Residence Time From Zero Time to Time of Last Quantifiable Concentration on Single Dose for Dotinurad |  | Day 1: 0-48 hours post dose | 
| Multiple-dose Part, Css,max: Maximum Observed Concentration at Steady State for Dotinurad |  | Day 10: 0-72 hours post dose | 
| Multiple-dose Part, Css,min: Minimum Observed Concentration at Steady State for Dotinurad |  | Day 10: 0-72 hours post dose | 
| Multiple-dose Part, Css,av: Average Steady-state Concentration for Dotinurad |  | Day 10: 0-72 hours post dose | 
| Multiple-dose Part, tss,max: Time at Which the Highest Drug Concentration Occurs at Steady State for Dotinurad |  | Day 10: 0-72 hours post dose | 
| Multiple-dose Part, t1/2: Terminal Elimination Phase Half-life for Dotinurad |  | Day 10: 0-72 hours post dose | 
| Multiple-dose Part, AUC0-τ: Area Under the Concentration-time Curve Over the Dosing Interval on Multiple Dosing for Dotinurad |  | Day 10: 0-72 hours post dose | 
| Multiple-dose Part, CLss/F: Apparent Total Clearance Following Oral Administration at Steady State for Dotinurad |  | Day 10: 0-72 hours post dose | 
| Multiple-dose Part, Vz/F: Apparent Volume of Distribution at Terminal Phase for Dotinurad |  | Day 10: 0-72 hours post dose | 
| Multiple-dose Part, kel: Elimination Rate Constant for Dotinurad |  | Day 10: 0-72 hours post dose | 
| Multiple-dose Part, MRT: Mean Residence Time for Dotinurad |  | Day 10: 0-72 hours post dose | 
| Multiple-dose Part, Rac(AUC0-24h): Accumulation Ratio for AUC(0-24h) |  | Day 10: 0-24 hours post dose | 
| Multiple-dose Part, Rac(Cmax): Accumulation Ratio for Cmax |  | Day 10: 0-72 hours post dose | 
| Multiple-dose Part, PTF: Peak-trough Fluctuation |  | Day 10: 0-72 hours post dose |