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

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ClinicalTrials.gov Identifier: NCT03959332
Recruitment Status : Recruiting
First Posted : May 22, 2019
Last Update Posted : June 3, 2019
Sponsor:
Collaborator:
Shionogi
Information provided by (Responsible Party):
Hoffmann-La Roche

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.

Condition or disease Intervention/treatment Phase
Healthy Volunteer Drug: Baloxavir Marboxil Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
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
Estimated Study Start Date : June 4, 2019
Estimated Primary Completion Date : June 29, 2019
Estimated Study Completion Date : June 29, 2019

Arm Intervention/treatment
Experimental: Baloxavir Marboxil 40 mg Drug: Baloxavir Marboxil
Participants will receive either 40 mg or 80 mg of baloxavir marboxil on Day 1 as a single oral dose.
Other Name: Xofluza

Experimental: Baloxavir Marboxil 80 mg Drug: Baloxavir Marboxil
Participants will receive either 40 mg or 80 mg of baloxavir marboxil on Day 1 as a single oral dose.
Other Name: Xofluza




Primary Outcome Measures :
  1. Maximum Plasma Concentration (Cmax) [ Time Frame: Up to Day 15 ]
  2. Time to Maximum Plasma Concentration (Tmax) [ Time Frame: Up to Day 15 ]
  3. Area Under the Concentration to Time Curve from Time 0 to Infinity (AUC0-inf) [ Time Frame: Up to Day 15 ]
  4. Area Under the Concentration to Time Curve from Time 0 to Last Quantifiable Concentration (AUC0-last) [ Time Frame: Up to Day 15 ]
  5. Area Under the Concentration to Time Curve from Time 0 to Time t (AUC0-t) [ Time Frame: Up to Day 15 ]
    Time t may be chosen as a time point where evaluable concentrations are available in at least 90% of participants.

  6. Terminal Elimination Half-Life (T1/2) [ Time Frame: Up to Day 15 ]
  7. Apparent Total Oral Clearance (CL/F) [ Time Frame: Up to Day 15 ]
  8. Apparent Oral Volume of Distribution (Vz/F) [ Time Frame: Up to Day 15 ]
  9. Plasma Concentrations 24 (C24), 48 (C48), and 72 Hours (C72) Postdose [ Time Frame: 24, 48 and 72 hours postdose ]

Secondary Outcome Measures :
  1. Percentage of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Up to Day 15 ]


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Ages Eligible for Study:   20 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03959332


Contacts
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Contact: YP40902 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global-roche-genentech-trials@gene.com

Locations
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China
Shanghai Xuhui Central Hospital Recruiting
Shanghai, China, 200031
Sponsors and Collaborators
Hoffmann-La Roche
Shionogi
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche

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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT03959332     History of Changes
Other Study ID Numbers: YP40902
First Posted: May 22, 2019    Key Record Dates
Last Update Posted: June 3, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Baloxavir
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action