A Study to Investigate the Relative Bioavailability of Entrectinib Capsule Formulations F1 and F06 Under Fed Conditions in Healthy Participants

  • Healthy Volunteers
Trial Status:

Completed

This trial runs in
Countries
  • United States
Trial Identifier:

NCT03796260 GP41048

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      The source of the below information is the publicly available website ClinicalTrials.gov. It has been summarised and edited into simpler language.

      The below information is taken directly from the publicly available website ClinicalTrials.gov within a week of any updates, and has not been edited.

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      Trial Summary

      This study aims to investigate the relative bioavailability, safety, and tolerability of entrectinib capsule formulations F1 and F06 under fed conditions in healthy adult male and female participants.

      Genentech, Inc. Sponsor
      Phase 1 Phase
      NCT03796260 , GP41048 Trial Identifier
      Entrectinib Test Formulation (F1), Entrectinib Reference Formulation (F06) Treatments
      Healthy Volunteers Condition
      Official Title

      A Randomized, Open-Label, Two-Treatment, Two-Period, Two-Way Crossover Study to Investigate the Relative Bioavailability of Entrectinib Capsule Formulations F1 and F06 Under Fed Conditions in Healthy Subjects

      Eligibility Criteria

      All Gender
      ≥18 Years & ≤ 60 Years Age
      Accepts Healthy Volunteers Healthy Volunteers
      Inclusion Criteria
      • Healthy in the opinion of the investigator. Healthy is defined by the absence of evidence of any active disease or clinically significant medical condition based on a detailed medical history and examination
      • Negative test results for Hepatitis B, Hepatitis C, and Human Immunodeficiency Virus (HIV)
      • Females must not be pregnant or breastfeeding, and females of childbearing potential will agree to use highly-effective contraception. Females of childbearing potential must also agree to refrain from donating eggs during the treatment period and for 6 weeks after the final dose of study drug
      • Males must agree to use contraception and to refrain from sperm donation from check-in (Day -1 of Period 1) to 90 days after the final dose of study drug
      Exclusion Criteria
      • History of gastrointestinal surgery or other gastrointestinal disorder that might affect absorption of medicines from the gastrointestinal tract
      • Presence of a clinically significant disease, illness, medical condition or disorder, or any other medical history determined by the investigator to be clinically significant and relevant. Ongoing chronic disorders which are not considered clinically significant are permissible providing they are stable
      • Clinically significant change in health status, as judged by the investigator, or any major illness within the 4 weeks before screening, or clinically significant acute infection or febrile illness within the 14 days before screening
      • Participation in any other clinical study involving an investigational medicinal product (IMP) or device within 30 days or 5 half-lives (if known), whichever is longer, before screening

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