NCT03959332

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 21, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 22, 2019

Completed
28 days until next milestone

Study Start

First participant enrolled

June 19, 2019

Completed
22 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 11, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 11, 2019

Completed
12 months until next milestone

Results Posted

Study results publicly available

June 22, 2020

Completed
Last Updated

August 11, 2020

Status Verified

July 1, 2020

Enrollment Period

22 days

First QC Date

May 21, 2019

Results QC Date

June 2, 2020

Last Update Submit

July 30, 2020

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (9)

  • Maximum Plasma Concentration (Cmax)

    Baloxavir marboxil and baloxavir concentrations were analyzed by validated Liquid Chromatography with tandem mass spectrometry (LC-MS/MS). Non-compartmental analysis was employed to estimate the PK parameters.

    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

  • Time to Maximum Plasma Concentration (Tmax)

    Baloxavir marboxil and baloxavir concentrations were analyzed by LC-MS/MS. Non-compartmental analysis was employed to estimate the PK parameters.

    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

  • Area Under the Concentration to Time Curve From Time 0 to Infinity (AUC0-inf)

    Baloxavir marboxil and baloxavir concentrations were analyzed by LC-MS/MS. Non-compartmental analysis was employed to estimate the PK parameters.

    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

  • Area Under the Concentration to Time Curve From Time 0 to Last Quantifiable Concentration (AUC0-last)

    Baloxavir marboxil and baloxavir concentrations were analyzed by LC-MS/MS. Non-compartmental analysis was employed to estimate the PK parameters.

    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

  • Area Under the Concentration to Time Curve From Time 0 to Time t (AUC0-t)

    Time t may be chosen as a time point where evaluable concentrations are available in at least 90% of participants. Baloxavir marboxil and baloxavir concentrations were analyzed by LC-MS/MS. Non-compartmental analysis was employed to estimate the PK parameters.

    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

  • Terminal Elimination Half-Life (T1/2)

    Baloxavir marboxil and baloxavir concentrations were analyzed by LC-MS/MS. Non-compartmental analysis was employed to estimate the PK parameters.

    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

  • Apparent Total Oral Clearance (CL/F)

    Baloxavir marboxil and baloxavir concentrations were analyzed by LC-MS/MS. Non-compartmental analysis was employed to estimate the PK parameters.

    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

  • Apparent Oral Volume of Distribution (Vz/F)

    Baloxavir marboxil and baloxavir concentrations were analyzed by LC-MS/MS. Non-compartmental analysis was employed to estimate the PK parameters.

    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

  • Plasma Concentrations 24 (C24), 48 (C48), and 72 Hours (C72) Postdose

    Baloxavir marboxil and baloxavir concentrations were analyzed by LC-MS/MS. Non-compartmental analysis was employed to estimate the PK parameters.

    24, 48 and 72 hours postdose

Secondary Outcomes (1)

  • Percentage of Participants With Adverse Events (AEs)

    Up to Day 15

Study Arms (2)

Baloxavir Marboxil 40 mg

EXPERIMENTAL
Drug: Baloxavir Marboxil

Baloxavir Marboxil 80 mg

EXPERIMENTAL
Drug: Baloxavir Marboxil

Interventions

Baloxavir MarboxilDRUG

Participants will receive either 40 mg or 80 mg of baloxavir marboxil on Day 1 as a single oral dose.

Also known as: Xofluza
Baloxavir Marboxil 40 mgBaloxavir Marboxil 80 mg

Eligibility Criteria

Age20 Years - 59 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Xuhui Central Hospital

Shanghai, 200031, China

Location

Related Publications (2)

  • 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.

    PMID: 35585696DERIVED

  • 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.

    PMID: 35176206DERIVED

MeSH Terms

Interventions

baloxavir

Results Point of Contact

Title
Medical Communications
Organization
Hoffmann-La Roche
genentech@druginfo.com
800 821-8590

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 21, 2019

First Posted

May 22, 2019

Study Start

June 19, 2019

Primary Completion

July 11, 2019

Study Completion

July 11, 2019

Last Updated

August 11, 2020

Results First Posted

June 22, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)