Select Your Region
Global
A study to measure how much of the study drug GDC-6036 is absorbed and the effect of food on absorption in healthy participants
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)
Basic Details
Male and Female
18 to 60 Years
Yes
Study Identifier
GP43039
Who can participate?
Healthy male and female volunteers aged 18 to 60 years, inclusive
What does the study involve?
Participants will be given a single oral dose of GDC-6036 on Day 1 in each period. Within each period, they will receive GDC-6036 as either a capsule after fasting, as a tablet after fasting, or as a tablet after eating a high-fat breakfast, with about one cup of water. Participants will receive each dose regimen once. The order in which participants will receive the different dosing regimens will be determined randomly. There will be a washout period (a time in which no dosing is given) of 5 days between each dosing.
The study drug will be given in the morning with one cup of water after an overnight fast (no food or drink other than water) of at least 8 hours. In one of the dosing periods, participants will be required to eat a high-fat breakfast consisting of two eggs fried in butter, two strips of bacon, two slices of toast with butter, 4 ounces of hash brown potatoes, and a cup of whole milk. Participants will need to eat the entire breakfast within 25 minutes, and dosing will be given within 10 minutes after finishing the meal. Participants will be required to remain fasting for 4 hours after dosing (a total fast of 12 hours for the 2 periods without breakfast) and will not be allowed to drink water (except for the water given with dosing) from 1 hour before dosing to 2 hours after dosing.
What are the possible benefits and risks of participating?
Participants are not expected to receive any direct benefits from the study, but the information that is learned may help other people in the future. During the study, some side effects (unwanted effects or health problems) from the study drug or from the study procedures may be experienced. Some of the common side effects are diarrhea, nausea, vomiting, elevated liver enzymes in the blood, fatigue (feeling tired), constipation, headache, abdominal pain, anemia (decrease in red blood cells), cough, decreased appetite, and reduced potassium level in the blood. There may also be a risk in exposing an unborn child to the study drug - the risks for this are not yet known. There may also be unknown, infrequent, and unforeseeable risks associated with the use of the study drug including severe or life-threatening allergic reactions or unexpected interactions with another medication.
Where is the study run from?
Genentech, Inc (USA)
When is the study starting and how long is it expected to run for?
January 2021 to October 2021
Who is funding the study?
Genentech, Inc (USA)
Who is the main contact?
[email protected]
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 study 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 information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.
Results Disclaimer
What you can do next
To find this study again later, copy and save the study number:
{{ctId}}
To see if this study is a good fit, talk to your doctor or nurse you trust.
Together, you can look at the For Medical Professional tab and look into your medical history.
Some medical centers in this study offer a contact line. Click "Find participating medical centers" in the map below.
For the latest version of this information please go to www.forpatients.roche.com