A 2 Part Study to Assess the Relative Bioavailability of Tablet Formulation Compared to Capsule Formulation and the Effect of Food and Taste Assessment on the Tablet Formulation in Healthy Participants

  • Healthy Volunteers
Please note that the recruitment status of the trial at your site may differ from the overall study status because some study sites may recruit earlier than others.
Trial Status:

Completed

This trial runs in
City
  • Millcreek
Trial Identifier:

NCT03847987 BP40950

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      The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical trial see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.

      The below information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

      Results Disclaimer

      Trial Summary

      This is a two-part, open-label, healthy volunteer study. Part I will investigate the relative bioavailability of capsule and tablet formulations of RO7017773. Part II will explore how the taste of the tablet formulation is perceived with and without added sweetener/flavoring.

      Hoffmann-La Roche Sponsor
      Phase 1 Phase
      NCT03847987,BP40950 Trial Identifier
      RO7017773 Phase I Capsule, RO7017773 Phase II Tablet Unflavored, RO7017773 Phase II Tablet Sweetened/Flavored Treatments
      Healthy Volunteers Condition
      Official Title

      A 2 Part, Randomized, Open-Label, Single Dose, Crossover Study to Assess the Relative Bioavailability of Phase II Tablet Formulation Compared to the Current Phase I Capsule Formulation and the Effect of Food and Taste Assessment on the Phase II Tablet Formulation in Healthy Participants

      Eligibility Criteria

      All Gender
      ≥18 Years & ≤ 55 Years Age
      Accepts Healthy Volunteers Healthy Volunteers
      Inclusion Criteria
      • Non-smoker for at least six months
      • Healthy, as judged by the Investigator
      • Women of non-childbearing potential (WONCBP) who are not pregnant or lactating
      • Men must be willing to remain abstinent or agree to use contraceptive measures with partners who are women of childbearing potential (WOCBP), and must refrain from donating sperm, for at least 28 days after the last dose of study drug
      Exclusion Criteria
      • History or evidence of any medical condition potentially altering the absorption, metabolism or elimination of drugs
      • History of convulsions (other than benign febrile convulsions of childhood) including epilepsy, or personal history of significant cerebral trauma or CNS infections (e.g. meningitis)
      • A history of clinically significant hypersensitivity (e.g., drugs, excipients) or allergic reactions
      • Current or chronic history of liver disease, or known hepatic or biliary abnormalities
      • Have used or intend to use over-the-counter or prescription medication including herbal medications within 30 days prior to dosing
      • Participation in an investigational drug or device study within 90 days prior to screening
      • Human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies
      • Presence of hepatitis B surface antigen (HBsAg) or positive hepatitis C antibody test result at screening or within 3 months prior to starting study treatment

      For the latest version of this information please go to www.forpatients.roche.com

       

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