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Small Molecule Inhibitor

Group A: Normal Hepatic Function for Liver Disease

Phase 1

Waitlist Available

Research Sponsored by Institut de Recherches Internationales Servier

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1 before dosing (0 hour) and at multiple time points up to 504 hours post-dose

Awards & highlights

Study Summary

This trial looks at how hepatic impairment affects how a drug is absorbed and used in the body.

Eligible Conditions

Liver Disease

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 before dosing (0 hour) and at multiple time points up to 504 hours post-dose

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1 before dosing (0 hour) and at multiple time points up to 504 hours post-dose

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 before dosing (0 hour) and at multiple time points up to 504 hours post-dose for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

AUC From Time 0 Extrapolated to Infinity (AUC0-inf) for Vorasidenib

Area Under the Plasma Concentration Versus Time Curve (AUC) From Time 0 to the Last Quantifiable Concentration (AUC0-t) for Vorasidenib

Maximum Observed Plasma Concentration (Cmax) of Vorasidenib

+1 more

Secondary outcome measures

AUC0-inf for Metabolite AGI-69460

AUC0-t for Metabolite AGI-69460

Apparent Oral Clearance (CL/F) for Vorasidenib

+12 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Group B: Moderate or Mild Hepatic ImpairmentExperimental Treatment1 Intervention

Stage 1: Participants with moderate hepatic impairment (Child-Pugh [C-P] Class B, score of 7 to 9) will receive a single oral dose of 20 mg (2 × 10 mg) vorasidenib tablets on Day 1. Stage 2: Participants with mild hepatic impairment (C-P Class A, score of 5 to 6) will receive a single oral dose of 20 mg (2 × 10 mg) vorasidenib tablets on Day 1. Stage 2 will be conducted if a clinically meaningful increase in exposure of vorasidenib is observed in participants with moderate hepatic impairment in Stage 1.

Group II: Group A: Normal Hepatic FunctionExperimental Treatment1 Intervention

Participants with normal hepatic function will receive a single oral dose of 20 mg (2 × 10 mg) vorasidenib tablets on Day 1.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Vorasidenib

2023

Completed Phase 1

~20

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Institut de Recherches Internationales ServierLead Sponsor

86 Previous Clinical Trials

67,120 Total Patients Enrolled

Frequently Asked Questions

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

Is eligibility for the clinical trial limited to a certain age range?

"This medical research project is open to participants aged 18 and above, up until those who are 70 years of age."

Answered by AI

Can you provide insight into the safety of Group A: Normal Hepatic Function for patients?

"In our evaluation, Group A: Normal Hepatic Function received a score of 1 as this is only an initial Phase 1 trial. This means that data confirming safety and efficacy are limited at present."

Answered by AI

Can I become involved in this medical experiment?

"In order to be considered for participation in this clinical trial, applicants must have a diagnosed liver condition and are within the 18-70 year old age range. 32 volunteer patients will take part in this research project."

Answered by AI

Is participation currently allowed in this research endeavor?

"According to the information located on clinicaltrials.gov, this trial is not actively seeking patients. It was initially posted in March 15th 2023 and most recently updated on 3/1/2023. Despite that, there are still 255 other trials looking for participants right now."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of Vorasidenib in Participants With Moderate or Mild Hepatic Impairment and Matched Participants With Normal Hepatic Function

2023. "A Study of Vorasidenib in Participants With Moderate or Mild Hepatic Impairment and Matched Participants With Normal Hepatic Function". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05674474.