Study to Assess the Pharmacokinetics, Safety and Tolerability of Baloxavir Marboxil in Healthy Chinese Participants
- Registration Number
- NCT03959332
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This study will evaluate the pharmacokinetics, safety and tolerability of a single oral dose of baloxavir marboxil (40 mg or 80 mg) in healthy Chinese participants.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 32
- Chinese participants must have Chinese parents and grandparents, all of whom were born in China.
- Healthy status as defined by absence of evidence of any active or chronic disease
- Participants whose body weight is ≥50 to <80 kg and body mass index is ≥18.5 to <26 kg/m2
- Participants with a history of stomach, vagus nerve, or intestinal surgery (except for appendectomy)
- Participants who have a history of allergic symptoms including food allergy (Note: Non-active allergic rhinitis will be allowed)
- Participants who require chronic drug therapy or those who have used drugs within 3 days prior to screening or within 14 days prior to Day -1
- Participants who have used alcohol-containing, caffeine-containing, grapefruit containing, or St. John's wort-containing products within 72 hours prior to Day -1
- Participants who have used tobacco- or nicotine-containing products within 24 weeks prior to screening
- Participants who have donated > 400 mL of blood within 12 weeks or > 200 mL of blood within 4 weeks prior to screening, or have donated any amount of blood between screening and Day -1
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Baloxavir Marboxil 40 mg Baloxavir Marboxil - Baloxavir Marboxil 80 mg Baloxavir Marboxil -
- Primary Outcome Measures
Name Time Method Time to Maximum Plasma Concentration (Tmax) Pre-dose and at 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48,72, 120, 168, 216, 264, and 336 hours post-dose Baloxavir marboxil and baloxavir concentrations were analyzed by LC-MS/MS. Non-compartmental analysis was employed to estimate the PK parameters.
Area Under the Concentration to Time Curve From Time 0 to Time t (AUC0-t) Pre-dose and at 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48,72, 120, 168, 216, 264, and 336 hours post-dose Time t may be chosen as a time point where evaluable concentrations are available in at least 90% of participants. Baloxavir marboxil and baloxavir concentrations were analyzed by LC-MS/MS. Non-compartmental analysis was employed to estimate the PK parameters.
Apparent Total Oral Clearance (CL/F) Pre-dose and at 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48,72, 120, 168, 216, 264, and 336 hours post-dose Baloxavir marboxil and baloxavir concentrations were analyzed by LC-MS/MS. Non-compartmental analysis was employed to estimate the PK parameters.
Maximum Plasma Concentration (Cmax) Pre-dose and at 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48,72, 120, 168, 216, 264, and 336 hours post-dose Baloxavir marboxil and baloxavir concentrations were analyzed by validated Liquid Chromatography with tandem mass spectrometry (LC-MS/MS). Non-compartmental analysis was employed to estimate the PK parameters.
Area Under the Concentration to Time Curve From Time 0 to Infinity (AUC0-inf) Pre-dose and at 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48,72, 120, 168, 216, 264, and 336 hours post-dose Baloxavir marboxil and baloxavir concentrations were analyzed by LC-MS/MS. Non-compartmental analysis was employed to estimate the PK parameters.
Area Under the Concentration to Time Curve From Time 0 to Last Quantifiable Concentration (AUC0-last) Pre-dose and at 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48,72, 120, 168, 216, 264, and 336 hours post-dose Baloxavir marboxil and baloxavir concentrations were analyzed by LC-MS/MS. Non-compartmental analysis was employed to estimate the PK parameters.
Plasma Concentrations 24 (C24), 48 (C48), and 72 Hours (C72) Postdose 24, 48 and 72 hours postdose Baloxavir marboxil and baloxavir concentrations were analyzed by LC-MS/MS. Non-compartmental analysis was employed to estimate the PK parameters.
Apparent Oral Volume of Distribution (Vz/F) Pre-dose and at 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48,72, 120, 168, 216, 264, and 336 hours post-dose Baloxavir marboxil and baloxavir concentrations were analyzed by LC-MS/MS. Non-compartmental analysis was employed to estimate the PK parameters.
Terminal Elimination Half-Life (T1/2) Pre-dose and at 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48,72, 120, 168, 216, 264, and 336 hours post-dose Baloxavir marboxil and baloxavir concentrations were analyzed by LC-MS/MS. Non-compartmental analysis was employed to estimate the PK parameters.
- Secondary Outcome Measures
Name Time Method Percentage of Participants With Adverse Events (AEs) Up to Day 15
Trial Locations
- Locations (1)
Shanghai Xuhui Central Hospital
🇨🇳Shanghai, China