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Completed

NCT Number: NCT03959332

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

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.

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Key information

Conditions

Age range

20 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai Xuhui Central Hospital

Shanghai, 200031, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Baloxavir Marboxil

Drug

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

Other names: Xofluza

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

Secondary outcomes

  1. Percentage of Participants With Adverse Events (AEs)

    Time frame: Up to Day 15

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Collaborators

  • Shionogi

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
May 22, 2019
Registry last updated
Aug 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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