Nitazoxanide Pharmacokinetic Parameters in Hepatic Impaired Patients

Phase 1

Waitlist Available

Research Sponsored by Genfit

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 plasma:day 1: pre-dose; 1; 2; 3; 4; 5; 6; 7; 8; 10, 12 h post dose day 7: pre-dose; 1; 2; 3; 4; 5; 6; 7; 8; 10; 12; 14; 16; 18; 24; and 48 h post dose urine:day-1: pre-dose, day 1: 24 hours urine collection post-dose; day 7: 48 hours urine collection

Awards & highlights

No Placebo-Only Group

Summary

This trial tests Nitazoxanide in adults with liver problems and healthy adults to see how the drug is processed in their bodies. Researchers want to understand if liver issues change how the medication works.

Eligible Conditions

Liver Damage
Liver Disease
Liver Impairment

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ plasma:day 1: pre-dose; 1; 2; 3; 4; 5; 6; 7; 8; 10, 12 h post dose day 7: pre-dose; 1; 2; 3; 4; 5; 6; 7; 8; 10; 12; 14; 16; 18; 24; and 48 h post dose urine:day-1: pre-dose, day 1: 24 hours urine collection post-dose; day 7: 48 hours urine collection

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~plasma:day 1: pre-dose; 1; 2; 3; 4; 5; 6; 7; 8; 10, 12 h post dose day 7: pre-dose; 1; 2; 3; 4; 5; 6; 7; 8; 10; 12; 14; 16; 18; 24; and 48 h post dose urine:day-1: pre-dose, day 1: 24 hours urine collection post-dose; day 7: 48 hours urine collection

This trial's timeline: 3 weeks for screening, Varies for treatment, and plasma:day 1: pre-dose; 1; 2; 3; 4; 5; 6; 7; 8; 10, 12 h post dose day 7: pre-dose; 1; 2; 3; 4; 5; 6; 7; 8; 10; 12; 14; 16; 18; 24; and 48 h post dose urine:day-1: pre-dose, day 1: 24 hours urine collection post-dose; day 7: 48 hours urine collection for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

AUC from time zero to the time of the last quantifiable concentration (AUC0-t)

Area under the plasma concentration time curve (AUC) from time zero to 12h (AUC0-12)

Maximum observed plasma concentration (Cmax)

Secondary study objectives

Plasma and urine pharmacokinetics: After the single oral administration of NTZ 500 mg: Cmax, AUC0-12, AUC0-t, AUC0-∞ , Tmax, t1/2, %AUCextrap, Ae0-∞, Ae0-t and CLR.

Plasma pharmacokinetics: Tmax, AUC0-12, AUC0-t, AUC0-∞, Cmax, t1/2, %AUCextrap and Ctrough.

Plasma pharmacokinetics: time of the maximum observed plasma concentration (Tmax), apparent plasma terminal elimination half life (t1/2), AUC from time zero to infinity (AUC0-∞), trough concentration (Ctrough) and percentage of extrapolated (%AUCextrap)

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