A study to find out if taking different forms of a study medicine (belvarafenib) gives you the same amount of medicine in your body, and if taking the study medicine with food can change the amount of medicine absorbed by the body

A phase 1, single-dose, randomized, open-label, crossover, relative bioavailability, and food-effect study of belvarafenib (GDC-5573) in healthy subjects

  • Cancer
Trial Status:

Completed

This trial runs in
Cities
Trial Identifier:

GP41348

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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

      Healthy volunteers (n=18) were enrolled at 1 study site in the United Kingdom to evaluate the pharmacokinetics and safety of two formulations (Form 1 and Form 2) of belvarafenib (GDC-5573), a small molecule inhibitor of the RAF family kinases designed to inhibit the MAPK pathway. This was a 3-treatment (A: Form 1 with food; B: Form 2 with food; C: Form 2 without food), 6-way crossover study (Group 1: A-B-C; Group 2: A-C-B; Group 3: B-A-C; Group 4: B-C-A; Group 5: C-A-B; Group 6: C-B-A), with an 18-day washout between treatments. Form 1 was the formulation for Phase 1 studies and Form 2 for Phase 2 studies.

      GP41348 Trial Identifier
      All Gender
      ≥18 Years Age
      Yes Healthy Volunteers

      This clinical trial was done to study a new medicine called, “belvarafenib”, for the treatment of patients with cancer. This study was done to find out if belvarafenib prepared one way (Form 1) was the same as when it was prepared another way (Form 2). The effect of food – taking the medicine with or without food – was also studied. Eighteen healthy people took part in this study in the United Kingdom.

      Trial Summary

      Healthy volunteers (n=18) were enrolled at 1 study site in the United Kingdom to evaluate the pharmacokinetics and safety of two formulations (Form 1 and Form 2) of belvarafenib (GDC-5573), a small molecule inhibitor of the RAF family kinases designed to inhibit the MAPK pathway. This was a 3-treatment (A: Form 1 with food; B: Form 2 with food; C: Form 2 without food), 6-way crossover study (Group 1: A-B-C; Group 2: A-C-B; Group 3: B-A-C; Group 4: B-C-A; Group 5: C-A-B; Group 6: C-B-A), with an 18-day washout between treatments. Form 1 was the formulation for Phase 1 studies and Form 2 for Phase 2 studies.

      GP41348 Trial Identifier
      Belvarafenib (GDC-5573) Treatments
      Official Title

      A phase 1, single-dose, randomized, open-label, crossover, relative bioavailability, and food-effect study of belvarafenib (GDC-5573) in healthy subjects

      Eligibility Criteria

      All Gender
      ≥18 Years Age
      Yes Healthy Volunteers

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