NCT03959332 is a NA clinical trial of Baloxavir Marboxil in Healthy Volunteer, sponsored by Hoffmann-La Roche.

Who is sponsoring NCT03959332?

NCT03959332 is sponsored by Hoffmann-La Roche.

What drugs are being tested in NCT03959332?

Interventions in NCT03959332: Baloxavir Marboxil.

What condition does NCT03959332 study?

NCT03959332 studies Healthy Volunteer.

Is NCT03959332 still recruiting?

NCT03959332 is currently completed. Last updated 11 August 2020.

Are results published for NCT03959332?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2020-08-11 · How we verify

NCT03959332

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed NA Results posted Last updated 11 August 2020

What this trial tests

NA trial testing Baloxavir Marboxil in Healthy Volunteer in 32 participants. Completed in 11 July 2019.

Timeline

19 June 2019

Primary endpoint
11 July 2019

11 July 2019

Quick facts

Lead sponsor	Hoffmann-La Roche
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	32
Start date	19 June 2019
Primary completion	11 July 2019
Estimated completion	11 July 2019
Sites	1 location across China

Drugs / interventions tested

Baloxavir Marboxil (BALOXAVIR MARBOXIL) — full drug profile →

Conditions studied

Healthy Volunteer — all drugs for Healthy Volunteer →

Sponsor

Hoffmann-La Roche — full company profile →

Who can join

Adults 20 to 59, any sex, with Healthy Volunteer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Maximum Plasma Concentration (Cmax) Primary · 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.

Baloxavir Marboxil

Group	Value	95% CI
Baloxavir Marboxil 80 mg	0.5133	± 3.7

Baloxavir

Group	Value	95% CI
Baloxavir Marboxil 40 mg	107.6	± 24.2
Baloxavir Marboxil 80 mg	206.9	± 38.3

Time to Maximum Plasma Concentration (Tmax) Primary · 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.

Baloxavir Marboxil

Group	Value	95% CI
Baloxavir Marboxil 80 mg	5.50	5.00 – 6.00

Baloxavir

Group	Value	95% CI
Baloxavir Marboxil 40 mg	4.00	3.00 – 6.00
Baloxavir Marboxil 80 mg	4.00	3.00 – 5.00

Area Under the Concentration to Time Curve From Time 0 to Infinity (AUC0-inf) Primary · 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.

Baloxavir

Group	Value	95% CI
Baloxavir Marboxil 40 mg	6955	± 25.5
Baloxavir Marboxil 80 mg	9643	± 29.4

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

Baloxavir

Group	Value	95% CI
Baloxavir Marboxil 40 mg	6442	± 24.3
Baloxavir Marboxil 80 mg	9218	± 29.2

Area Under the Concentration to Time Curve From Time 0 to Time t (AUC0-t) Primary · 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.

Baloxavir

Group	Value	95% CI
Baloxavir Marboxil 40 mg	6442	± 24.3
Baloxavir Marboxil 80 mg	9218	± 29.2

Terminal Elimination Half-Life (T1/2) Primary · 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.

Baloxavir

Group	Value	95% CI
Baloxavir Marboxil 40 mg	99.74	± 18.0
Baloxavir Marboxil 80 mg	88.89	± 17.1

Apparent Total Oral Clearance (CL/F) Primary · 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.

Baloxavir

Group	Value	95% CI
Baloxavir Marboxil 40 mg	4.866	± 25.5
Baloxavir Marboxil 80 mg	7.019	± 29.4

Apparent Oral Volume of Distribution (Vz/F) Primary · 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.

Baloxavir

Group	Value	95% CI
Baloxavir Marboxil 40 mg	700.1	± 26.6
Baloxavir Marboxil 80 mg	900.1	± 31.4

Plasma Concentrations 24 (C24), 48 (C48), and 72 Hours (C72) Postdose Primary · 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.

Baloxavir C24

Group	Value	95% CI
Baloxavir Marboxil 40 mg	56.40	± 22.8
Baloxavir Marboxil 80 mg	92.01	± 27.9

Baloxavir C48

Group	Value	95% CI
Baloxavir Marboxil 40 mg	41.38	± 22.9
Baloxavir Marboxil 80 mg	60.33	± 33.2

Baloxavir C72

Group	Value	95% CI
Baloxavir Marboxil 40 mg	29.27	± 25.0
Baloxavir Marboxil 80 mg	41.78	± 31.6

Percentage of Participants With Adverse Events (AEs) Secondary · Up to Day 15

Group	Value	95% CI
Baloxavir Marboxil 40 mg	18.8
Baloxavir Marboxil 80 mg	68.8

Adverse events — posted to ClinicalTrials.gov

Time frame: Baseline up to Day 15. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Baloxavir Marboxil 40 mg

Serious: 0/16 (0%)

Deaths: 0/16

Baloxavir Marboxil 80 mg

Serious: 0/16 (0%)

Deaths: 0/16

Other adverse events (10 terms — click to expand)

Reaction	System	Baloxavir Marboxil 40 mg	Baloxavir Marboxil 80 mg
Upper respiratory tract infection	Infections and infestations	—	—
Blood bilirubin increased	Investigations	—	—
Blood uric acid increased	Investigations	—	—
Dizziness	Nervous system disorders	—	—
Diarrhoea	Gastrointestinal disorders	—	—
Electrocardiogram T wave abnormal	Investigations	—	—
Defect conduction intraventricular	Cardiac disorders	—	—
Ventricular extrasystoles	Cardiac disorders	—	—
Fatigue	General disorders	—	—
Haematuria	Renal and urinary disorders	—	—

Data from ClinicalTrials.gov NCT03959332 adverse events section.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Baloxavir Marboxil: An Original New Drug against Influenza.
Dufrasne F. · · 2021 · cited 34× · PMID 35056085 · DOI 10.3390/ph15010028
Pharmacokinetics, safety, and simulated efficacy of an influenza treatment, baloxavir marboxil, in Chinese individuals.
Liu Y, Retout S, Duval V, Jia J, et al · · 2022 · cited 12× · PMID 35176206 · DOI 10.1111/cts.13237
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.
Retout S, De Buck S, Jolivet S, Duval V, et al · · 2022 · cited 2× · PMID 35585696 · DOI 10.1002/cpt.2648

Verify or expand the search:

Other trials of Baloxavir Marboxil

Trials testing the same drug.

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NCT06161454 — Xofluza-Wearables Feasibility-Study · Phase 4 · completed
NCT06094010 — A Surveillance Study of Susceptibility to Baloxavir Marboxil in Pediatric Participants With Influenza and Transmission o · Phase 3 · recruiting

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Other Hoffmann-La Roche trials

Trials by the same sponsor.

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03959332 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Hoffmann-La Roche
Last refreshed: 11 August 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03959332.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT03959332

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Sponsor's own description

Publications & conference data

Related trials

Other trials of Baloxavir Marboxil

Other recruiting trials for Healthy Volunteer

Other Hoffmann-La Roche trials

Verify against primary sources