Clinical trial NCT03959332: Study to Assess the Pharmacokinetics, Safety and Tolerability of Baloxavir Marboxil in Healthy Chinese Participants
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
Collaborators: name: Shionogi
First posted: 2019-05-22
Enrollment: 32
Sex: ALL
Minimum age (years): 20
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.


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

Primary outcomes:
measure: Maximum Plasma Concentration (Cmax)
timeFrame: Pre-dose and at 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48,72, 120, 168, 216, 264, and 336 hours post-dose
measure: Time to Maximum Plasma Concentration (Tmax)
timeFrame: Pre-dose and at 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48,72, 120, 168, 216, 264, and 336 hours post-dose
measure: Area Under the Concentration to Time Curve From Time 0 to Infinity (AUC0-inf)
timeFrame: Pre-dose and at 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48,72, 120, 168, 216, 264, and 336 hours post-dose
measure: Area Under the Concentration to Time Curve From Time 0 to Last Quantifiable Concentration (AUC0-last)
timeFrame: Pre-dose and at 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48,72, 120, 168, 216, 264, and 336 hours post-dose
measure: Area Under the Concentration to Time Curve From Time 0 to Time t (AUC0-t)
timeFrame: Pre-dose and at 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48,72, 120, 168, 216, 264, and 336 hours post-dose
measure: Terminal Elimination Half-Life (T1/2)
timeFrame: Pre-dose and at 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48,72, 120, 168, 216, 264, and 336 hours post-dose
measure: Apparent Total Oral Clearance (CL/F)
timeFrame: Pre-dose and at 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48,72, 120, 168, 216, 264, and 336 hours post-dose
measure: Apparent Oral Volume of Distribution (Vz/F)
timeFrame: Pre-dose and at 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48,72, 120, 168, 216, 264, and 336 hours post-dose
measure: Plasma Concentrations 24 (C24), 48 (C48), and 72 Hours (C72) Postdose
timeFrame: 24, 48 and 72 hours postdose
Secondary outcomes:
measure: Percentage of Participants With Adverse Events (AEs)
timeFrame: Up to Day 15
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Xuhui Central Hospital
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Retout S, De Buck S, Jolivet S, Duval V, Cosson V. A Pharmacokinetics-Time to Alleviation of Symptoms Model to Support Extrapolation of Baloxavir Marboxil Clinical Efficacy in Different Ethnic Groups with Influenza A or B. Clin Pharmacol Ther. 2022 Aug;112(2):372-381. doi: 10.1002/cpt.2648. Epub 2022 Jun 10.
citation: Liu Y, Retout S, Duval V, Jia J, Zou Y, Wang Y, Cosson V, Jolivet S, De Buck S. Pharmacokinetics, safety, and simulated efficacy of an influenza treatment, baloxavir marboxil, in Chinese individuals. Clin Transl Sci. 2022 May;15(5):1196-1203. doi: 10.1111/cts.13237. Epub 2022 Feb 19.