A study to find out if taking different forms of a medicine (GDC-6036) results in the same amount of medicine in your body – and the effect of food on the medicine
A Phase 1, Open-Label, Single-Dose, Randomized, Three-Period Crossover Study to Evaluate the Relative Bioavailability and Food Effect of GDC-6036 in Healthy Subjects
- Cancer
- Lung Cancer
- Non-Small Cell Lung Cancer (NSCLC)
Completed
- United States
GP43039
Trial Summary
This clinical trial was done to study “GDC-6036”, a medicine for the treatment of patients with cancer. This phase 1 study investigated how much medicine was delivered to the body by the capsule and tablet forms – the relative bioavailability of GDC-6036. It also investigated whether there was a difference if GDC-6036 was taken after eating or on an empty stomach – the food effect on GDC-6036. Seventeen healthy men took part in this study at one study center in one country – the USA.
Healthy volunteers were enrolled at one study site in USA to evaluate the relative bioavailability of tablet and capsule formulations, and the effect of food, on GDC-6036. Seventeen participants enrolled in the phase 1, open-label, randomized, three-period crossover, single-dose study. Results showed the capsule and tablet formulations to have similar bioavailability. Taking GDC-6036 after a meal slowed down the absorption rate and lowered the peak concentration reached – in comparison to taking GDC-6036 on an empty stomach. Study results will support other ongoing studies on GDC-6036, a KRAS G12C inhibitor.
Trial Summary
This clinical trial was done to study “GDC-6036”, a medicine for the treatment of patients with cancer. This phase 1 study investigated how much medicine was delivered to the body by the capsule and tablet forms – the relative bioavailability of GDC-6036. It also investigated whether there was a difference if GDC-6036 was taken after eating or on an empty stomach – the food effect on GDC-6036. Seventeen healthy men took part in this study at one study center in one country – the USA.
A phase 1, open-label, single-dose, randomized, three-period crossover study to evaluate the relative bioavailability and food effects of GDC-6036 in healthy subjects
Eligibility Criteria
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