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

Roche

Status

Completed

Conditions

Healthy Volunteer

Treatments

Drug: Baloxavir Marboxil

Study type

Interventional

Funder types

Industry

Identifiers

NCT03959332

YP40902

Details and patient eligibility

About

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.

Enrollment

32 patients

Sex

All

Ages

20 to 59 years old

Volunteers

Accepts 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