- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03959332
Study to Assess the Pharmacokinetics, Safety and Tolerability of Baloxavir Marboxil in Healthy Chinese Participants
July 30, 2020 updated by: Hoffmann-La Roche
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
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
32
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Shanghai, China, 200031
- Shanghai Xuhui Central Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 59 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Baloxavir Marboxil 40 mg
|
Participants will receive either 40 mg or 80 mg of baloxavir marboxil on Day 1 as a single oral dose.
Other Names:
|
Experimental: Baloxavir Marboxil 80 mg
|
Participants will receive either 40 mg or 80 mg of baloxavir marboxil on Day 1 as a single oral dose.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximum Plasma Concentration (Cmax)
Time Frame: 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
|
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)
Time Frame: 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
|
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)
Time Frame: 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
|
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)
Time Frame: 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
|
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 Frame: 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 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)
Time Frame: 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
|
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)
Time Frame: 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
|
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)
Time Frame: 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
|
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
Time Frame: 24, 48 and 72 hours 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 Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Percentage of Participants With Adverse Events (AEs)
Time Frame: Up to Day 15
|
Up to Day 15
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 19, 2019
Primary Completion (Actual)
July 11, 2019
Study Completion (Actual)
July 11, 2019
Study Registration Dates
First Submitted
May 21, 2019
First Submitted That Met QC Criteria
May 21, 2019
First Posted (Actual)
May 22, 2019
Study Record Updates
Last Update Posted (Actual)
August 11, 2020
Last Update Submitted That Met QC Criteria
July 30, 2020
Last Verified
July 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- YP40902
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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