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

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

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 Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: Dotinurad

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Shanghai, China
    • Shanghai Xuhui District Central Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort A Single Dose: Dotinurad; 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; Dotinurad oral tablet.; Other Names: FYU-981
Experimental: Cohort B Multiple Dose: Dotinurad; 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; Dotinurad oral tablet.; Other Names: FYU-981
Experimental: Cohort C Single Dose: Dotinurad; 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; Dotinurad oral tablet.; Other Names: FYU-981

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Eisai Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2022
• Primary Completion (Actual): December 13, 2022
• Study Completion (Actual): December 13, 2022

Study Registration Dates

• First Submitted: February 18, 2022
• First Submitted That Met QC Criteria: March 4, 2022
• First Posted (Actual): March 14, 2022

Study Record Updates

• Last Update Posted (Actual): September 14, 2023
• Last Update Submitted That Met QC Criteria: September 13, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Antirheumatic Agents; Gout Suppressants; Uricosuric Agents; Dotinurad
• Other Study ID Numbers: FYU-981-J086-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No