Clinical trial NCT05278676: A Single and Multiple Dose Study of Dotinurad in Chinese Healthy Participants
Official title: A Single and Multiple Dose Pharmacokinetic Study of Dotinurad in Chinese Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2022-03-14
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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.


Eligibility criteria: 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.

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