← Back to Search

Fasting condition / Low-fat meal for Healthy Subjects

Phase 1
Recruiting
Research Sponsored by Servier Bio-Innovation LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up before dosing and at multiple time points up to 504 hours on day 22 after administration of vorasidenib.
Awards & highlights

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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~before dosing and at multiple time points up to 504 hours on day 22 after administration of vorasidenib.
This trial's timeline: 3 weeks for screening, Varies for treatment, and before dosing and at multiple time points up to 504 hours on day 22 after administration of vorasidenib. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
AUC0-inf of Vorasidenib (substudy A)
AUC0-inf of Vorasidenib (substudy B)
AUC0-t of Vorasidenib (substudy A)
+5 more
Secondary outcome measures
AUC0-12 of ciprofloxacin (substudy B)
AUC0-inf of AGI-69460 (substudy A)
AUC0-inf of AGI-69460 (substudy B)
+15 more

Trial Design

4Treatment groups
Experimental Treatment
Group I: Vorasidenib and ciprofloxacinExperimental Treatment2 Interventions
Single oral dose of vorasidenib 2×10 mg tablets administered on Day 1 and twice daily (morning and evening) oral doses of ciprofloxacin 1×500 mg tablet on Days 1 through 14.
Group II: VorasidenibExperimental Treatment1 Intervention
Single oral dose of vorasidenib 2×10 mg tablets administered on Day 1.
Group III: Low-fat meal / Fasted conditionExperimental Treatment1 Intervention
A single oral dose of 1×40 mg vorasidenib tablet administered following a low-fat meal or under fasted conditions.
Group IV: Fasting condition / Low-fat mealExperimental Treatment1 Intervention
A single oral dose of 1×40 mg vorasidenib tablet administered under fasted conditions or following a low-fat meal.

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Servier Bio-Innovation LLCLead Sponsor
6 Previous Clinical Trials
593 Total Patients Enrolled
Institut de Recherches Internationales ServierOTHER
86 Previous Clinical Trials
69,497 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

Who else is applying?

What state do they live in?
Kansas
Texas
What site did they apply to?
PPD Development
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0

What questions have other patients asked about this trial?

When does it start and what is the compensation?
PatientReceived 1 prior treatment

Why did patients apply to this trial?

Hoping to help future patients.
PatientReceived 2+ prior treatments
~33 spots leftby Mar 2025