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

• Status: Completed
• Trial end date: 2019-07-11
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Hoffmann-La Roche
• Collaborator: Shionogi
• Treatments: Baloxavir

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