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Study to Assess the Pharmacokinetics, Safety and Tolerability of Baloxavir Marboxil in Healthy Chinese Participants
- Healthy Volunteers
Please note that the recruitment status of the trial at your site may differ from the overall study status because some study sites may recruit earlier than others.
Trial Status:
Completed
This trial runs in
N/A
Trial Identifier:
NCT03959332 YP40902
Trial 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.
Hoffmann-La Roche
Sponsor
N/A
Phase
NCT03959332, YP40902
Trial Identifier
Baloxavir Marboxil
Treatments
Healthy Volunteer
Condition
Official Title
A Phase I, Single-Centre, Open-Label, Parallel, Two Dose Level Study to Investigate the Pharmacokinetics, Safety, and Tolerability Following a Single Dose of Baloxavir Marboxil in Healthy Chinese Volunteers
Eligibility Criteria
All
Gender
≥20 Years & ≤ 59 Years
Age
Accepts Healthy Volunteers
Healthy Volunteers
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 <80 kg and body mass index is ≥18.5 to <26 kg/m2
Exclusion Criteria
- 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
For the latest version of this information please go to www.forpatients.roche.com