Recent Updates
Recently added Catalysts

Nitazoxanide

Phase 1

Renal Impairment | Small molecule | Nephrology |Genfit SA Sponsored ADR|Last Updated: Oct 28, 2022

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
CONTROLLEDBiomarker
Total Trials1
Total Enrollment77
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05368935Nitazoxanide Pharmacokinetic Parameters in Renal Impaired SubjectsPHASE1 COMPLETED 77 — — Apr 25, 2022Sep 9, 2022Oct 28, 20222 United States
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Maximum observed plasma concentration (Cmax)
Day 1: pre-dose; 1; 2; 3; 4; 5; 6; 7; 8; 10 and 12 hours post dose; Day 2-6: pre-dose; Day 7: pre-dose; 1; 2; 3; 4; 5; 6; 7; 8; 10; 12; 14; 16; 18; 24 hours (Day 8); 48 hours (Day 9); 72 hours (Day 10) and 96 hours (Day 11) post-dose

Plasma pharmacokinetic (PK) parameters of NTZ active metabolite expressed in terms of unbound as well as total concentrations at steady-state in subjects with mild, moderate and severe renal impairment compared to healthy volunteers

Area under the plasma concentration time curve (AUC) from time zero to the time of the last quantifiable concentration (AUC0-t)
Day 1: pre-dose; 1; 2; 3; 4; 5; 6; 7; 8; 10 and 12 hours post dose; Day 2-6: pre-dose; Day 7: pre-dose; 1; 2; 3; 4; 5; 6; 7; 8; 10; 12; 14; 16; 18; 24 (Day 8); 48 (Day 9); 72 (Day 10) and 96 (Day 11) hours post-dose

Plasma pharmacokinetic parameters of NTZ active metabolite expressed in terms of unbound as well as total concentrations at steady-state in subjects with mild, moderate and severe renal impairment compared to healthy volunteers

AUC from time zero to 12h (AUC0-12)
Day 1: pre-dose; 1; 2; 3; 4; 5; 6; 7; 8; 10 and 12 hours post dose; Day 2-6: pre-dose; Day 7: pre-dose; 1; 2; 3; 4; 5; 6; 7; 8; 10; 12; 14; 16; 18; 24 hours (Day 8); 48 hours (Day 9); 72 hours (Day 10) and 96 hours (Day 11) post-dose

Plasma pharmacokinetic parameters of NTZ active metabolite expressed in terms of unbound as well as total concentrations at steady-state in subjects with mild, moderate and severe renal impairment compared to healthy volunteers

Secondary Endpoints
Time of the maximum observed plasma concentration (Tmax) for NTZ and its major active metabolite
Day 1: pre-dose; 1; 2; 3; 4; 5; 6; 7; 8; 10 and 12 hours post dose; Day 2-6: pre-dose; Day 7: pre-dose; 1; 2; 3; 4; 5; 6; 7; 8; 10; 12; 14; 16; 18 hours; 24 hours (Day 8); 48 hours (Day 9) ; 72 hours (Day 10) and 96 hours (Day 11) post-dose
Apparent plasma terminal elimination half-life (t1/2) for the NTZ and its major active metabolite
Day 1: pre-dose; 1; 2; 3; 4; 5; 6; 7; 8; 10 and 12 hours post dose; Day 2-6: pre-dose; Day 7: pre-dose; 1; 2; 3; 4; 5; 6; 7; 8; 10; 12; 14; 16; 18 hours; 24 hours (Day 8); 48 hours (Day 9) ; 72 hours (Day 10) and 96 hours (Day 11) post-dose
Unbound fraction in plasma defined as total concentration/unbound concentration (fu) for the NTZ and its major active metabolite
Day 1: pre-dose; 1; 2; 3; 4; 5; 6; 7; 8; 10 and 12 hours post dose; Day 2-6: pre-dose; Day 7: pre-dose; 1; 2; 3; 4; 5; 6; 7; 8; 10; 12; 14; 16; 18 hours; 24 hours (Day 8); 48 hours (Day 9) ; 72 hours (Day 10) and 96 hours (Day 11) post-dose
Unlock Study Endpoints
Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
Healthy Control Match (RF ≥ 90 mL/min)EXPERIMENTAL500 mg Twice Daily for 7 days
Mild Renal Impairment (RF ≥ 60 to < 90 mL/min)EXPERIMENTAL500 mg Twice Daily for 7 days
Moderate Renal Impairment (RF ≥ 30 to < 60 mL/min)EXPERIMENTAL500 mg Twice Daily for 7 days
Severe Renal Impairment (RF < 30 mL/min and not on dialysis)EXPERIMENTAL500 mg Twice Daily for 7 days
Interventions
NameTypeDescription
NitazoxanideDRUG500 mg Twice Daily for 7 days
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — 80 Years
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: 1. Males or females, between 18 and 80 years of age, inclusive 2. With a minimum body weight of ≥ 50.0 kg for males and ≥ 45.0 kg for females and within a BMI range of 18.0 to 40.0 kg/m\^2, inclusive 3. Females participating in this study must be of non-childbearing potential or...

Countries:United States
Unlock Eligibility Criteria