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Study to Assess the Pharmacokinetics, Safety and Tolerability of Baloxavir Marboxil in Healthy Chinese Participants

CompletedNA

Sponsor: Hoffmann-La Roche

Conditions: Healthy Volunteer

Interventions: Baloxavir Marboxil

Countries: China

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.

Eligibility overview

Sex: ALL

Age: 20 Years to 59 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

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 \<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

Locations (1)

Shanghai, China