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Group B: Moderate or Mild Hepatic Impairment for Liver Disease

American Research Corporation, San Antonio, TX
Liver DiseaseVorasidenib - Drug
Eligibility
18 - 70
All Sexes

Study Summary

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

Eligible Conditions
  • Liver Disease

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 1

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1
Fasting condition / Low-fat meal
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PF-07081532
1
Participants with moderate hepatic impairment

Study Objectives

4 Primary · 15 Secondary · Reporting Duration: Day 1 before dosing (0 hour) and at multiple time points up to 504 hours post-dose

Day 1
AUC From Time 0 Extrapolated to Infinity (AUC0-inf) for Vorasidenib
AUC0-inf for Metabolite AGI-69460
AUC0-t for Metabolite AGI-69460
Apparent Oral Clearance (CL/F) for Vorasidenib
Apparent Terminal Elimination Half-life (t1/2) of Vorasidenib
Apparent Volume of Distribution (Vz/F) of Vorasidenib
Area Under the Plasma Concentration Versus Time Curve (AUC) From Time 0 to the Last Quantifiable Concentration (AUC0-t) for Vorasidenib
Area Under the Unbound Plasma Concentration Versus Time Curve Extrapolated to Infinity (AUCinf,u) for Vorasidenib
Area Under the Unbound Plasma Concentration Versus Time Curve From Time 0 to the Last Quantifiable Concentration (AUC0-t,u) for Vorasidenib
Cmax of Metabolite AGI-69460
Maximum Observed Plasma Concentration (Cmax) of Vorasidenib
Maximum Observed Unbound Plasma Concentration (Cmax,u) of Vorasidenib
Time to Reach Maximum Observed Plasma Concentration (Tmax) for Vorasidenib
Tmax of Metabolite AGI-69460
Day 29
Number of Participants With Abnormalities in 12-Lead Electrocardiogram (ECG) Results
Number of Participants With Abnormalities in Laboratory Parameters
Number of Participants With Abnormalities in Physical Examination Findings
Number of Participants With Abnormalities in Vital Signs
Day 29
Number of Participants With Adverse Events (AEs)

Trial Safety

Phase-Based Safety

1 of 3

Similar Trials

1
Fasting condition / Low-fat meal
1
PF-07081532
1
Participants with moderate hepatic impairment

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

2 Treatment Groups

Group B: Moderate or Mild Hepatic Impairment
1 of 2
Group A: Normal Hepatic Function
1 of 2

Experimental Treatment

32 Total Participants · 2 Treatment Groups

Primary Treatment: Group B: Moderate or Mild Hepatic Impairment · No Placebo Group · Phase 1

Group B: Moderate or Mild Hepatic Impairment
Drug
Experimental Group · 1 Intervention: Vorasidenib · Intervention Types: Drug
Group A: Normal Hepatic Function
Drug
Experimental Group · 1 Intervention: Vorasidenib · Intervention Types: Drug

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: day 1 before dosing (0 hour) and at multiple time points up to 504 hours post-dose

Who is running the clinical trial?

Institut de Recherches Internationales ServierLead Sponsor
79 Previous Clinical Trials
69,567 Total Patients Enrolled

Eligibility Criteria

Age 18 - 70 · All Participants · 0 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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