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

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05278676
• Other study ID #: FYU-981-J086-001
• Status: Completed
• Phase: Phase 1
• Start date: July 1, 2022
• Est. completion date: December 13, 2022

Study information

• Verified date: February 2023
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: December 13, 2022
• Est. primary completion date: December 13, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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 [ß-hCG] or human chorionic gonadotropin [hCG] test). A separate baseline assessment of serum ß-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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Dotinurad
Dotinurad oral tablet.

Locations

Country	Name	City	State
China	Shanghai Xuhui District Central Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Eisai Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

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