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Fasting condition / Low-fat meal for Healthy Subjects
Study Summary
This trial studies the effects of a low-fat meal and a medicine on the way vorasidenib is absorbed and used in the body in healthy adults.
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Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Frequently Asked Questions
How many participants have been recruited for this clinical trial?
"Affirmative. According to clinicaltrials.gov, the medical trial that was first published on April 14th 2023 is still recruiting participants. 64 individuals from a single centre are needed for this study's completion."
Is my profile suitable to partake in this experiment?
"In order to qualify for this research trial, applicants should be in good health and aged between 18–55 years. Ultimately, the study aims to onboard 64 individuals."
Has the Federal Drug Administration sanctioned fasting condition / low-fat meal?
"Taking into account its status as a Phase 1 trial, limited data available to support safety and efficacy suggest that the Fasting condition / Low-fat meal should be classified with a score of one."
Are elderly individuals being considered for participation in this trial?
"To be eligible for this trial, patients must meet the age criteria of 18 to 55 years old. There are currently 56 clinical studies specifically targeting those under 18 and 365 trials working with participants over 65."
Are volunteers currently being accepted for the research project?
"Affirmative. Per the clinicaltrials.gov database, this trial is presently recruiting individuals to participate in it; the initial posting was April 14th 2023, with a subsequent update on May 3rd of that year. 64 participants need to be recruited from 1 particular site."
What primary results is this medical study aiming to achieve?
"The primary assessment of this trial will focus on the maximal absorption (Tmax) rate of Vorasidenib, which is to be evaluated from pre-dosing (0 hours), through 504 post-treatment. Secondary metrics include Clearance/Factor of Vorasidenib, Volume/Fraction for Vorasidenib and Maximum Concentration level for AGI-69460 respectively."
Who else is applying?
What state do they live in?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
What questions have other patients asked about this trial?
Why did patients apply to this trial?
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