N/A
Completed N=32
Study to Assess the Pharmacokinetics, Safety and Tolerability of Baloxavir Marboxil in Healthy Chinese Participants
Healthy Volunteer
Source: ClinicalTrials.gov NCT03959332 ↗
Enrolled (actual)
32
Serious AEs
0.0%
Results posted
Jun 2020
Primary outcomePrimary: Maximum Plasma Concentration (Cmax) — 0.5133; 107.6; 206.9 nanogram per milliliter (ng/mL)
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Plasma Concentration (Cmax) |
0.5133; 107.6; 206.9 | — |
| PRIMARY Time to Maximum Plasma Concentration (Tmax) |
5.50; 4.00; 4.00 | — |
| PRIMARY Area Under the Concentration to Time Curve From Time 0 to Infinity (AUC0-inf) |
6955; 9643 | — |
| PRIMARY Area Under the Concentration to Time Curve From Time 0 to Last Quantifiable Concentration (AUC0-last) |
6442; 9218 | — |
| PRIMARY Area Under the Concentration to Time Curve From Time 0 to Time t (AUC0-t) |
6442; 9218 | — |
| PRIMARY Terminal Elimination Half-Life (T1/2) |
99.74; 88.89 | — |
| PRIMARY Apparent Total Oral Clearance (CL/F) |
4.866; 7.019 | — |
| PRIMARY Apparent Oral Volume of Distribution (Vz/F) |
700.1; 900.1 | — |
| PRIMARY Plasma Concentrations 24 (C24), 48 (C48), and 72 Hours (C72) Postdose |
56.40; 92.01; 41.38; 60.33; 29.27; 41.78 | — |
| SECONDARY Percentage of Participants With Adverse Events (AEs) |
18.8; 68.8 | — |
Eligibility Criteria
Inclusion Criteria
- 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 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
Data sourced from ClinicalTrials.gov (NCT03959332). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.