Recent Updates
Recently added Catalysts

-Poziotinib

Phase 1

Healthy | Small molecule | Other |Assertio Holdings, Inc.|Last Updated: Sep 5, 2021

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 Trials2
Total Enrollment82
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04981704A Study to Evaluate the Effect of Multiple Doses of Itraconazole, Phenytoin, and Paroxetine on the Single-Dose Pharmacokinetics of Poziotinib in Healthy Adult ParticipantsPHASE1 COMPLETED 74 — — Apr 8, 2021Aug 17, 2021Sep 5, 20211 United States
NCT04436562Study of the Absorption, Metabolism, and Excretion Following a Single Dose of [14C]-Poziotinib in Healthy Male SubjectsPHASE1 COMPLETED 8 — — May 29, 2020Jul 17, 2020Jan 15, 20211 United States
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Area Under the Curve (AUC) of Poziotinib and Metabolites (M1 and M2) Following Poziotinib Administrations With and Without Itraconazole [Part 1], Phenytoin [Part 2], or Paroxetine [Part 3]
Part 1 and Part 3, predose and up to 120 hours postdose; Part 2, predose and up to 96 hours postdose
Maximum Observed Concentration (Cmax) of Poziotinib and Metabolites (M1 and M2) Following Poziotinib Administration With and Without Itraconazole [Part 1], Phenytoin [Part 2], or Paroxetine [Part 3]
Part 1 and Part 3, predose and up to 120 hours postdose; Part 2, predose and up to 96 hours postdose
Apparent Clearance (CL/F) of Poziotinib Following Poziotinib Administration With and Without Itraconazole [Part 1], Phenytoin [Part 2], or Paroxetine [Part 3]
Part 1 and Part 3, predose and up to 120 hours postdose; Part 2, predose and up to 96 hours postdose
Time to Maximum Observed Concentration (Tmax) for Poziotinib and Metabolites (M1 and M2) Following Poziotinib Administration With and Without Itraconazole [Part 1], Phenytoin [Part 2], or Paroxetine [Part 3]
Part 1 and Part 3, predose and up to 120 hours postdose; Part 2, predose and up to 96 hours postdose
Maximum Observed Plasma Concentration (Cmax) of [14C]-Poziotinib, Metabolites M1 and M2
1-15 days
Cmax of Total Radioactivity of [14C]-Poziotinib in Whole Blood and Plasma
1-15 days
Time to Attain Maximum Observed Plasma Concentration (Tmax) of [14C]-Poziotinib, Metabolites M1 and M2
1-15 days
Tmax of Total Radioactivity of [14C]-Poziotinib in Whole Blood and Plasma
1-15 days
Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC[last]) of [14C]-Poziotinib, Metabolites M1 and M2
1-15 days
AUC(last) of Total Radioactivity of [14C]-Poziotinib in Whole Blood and Plasma
1-15 days
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUCinf) of [14C]-Poziotinib, Metabolites M1 and M2
1-15 days
AUC(inf) of Total Radioactivity of [14C]-Poziotinib in Whole Blood and Plasma
1-15 days
Percentage of AUCinf Derived by Extrapolation (%AUCext) of [14C]-Poziotinib, Metabolites M1 and M2
1-15 days
%AUCext of Total Radioactivity of [14C]-Poziotinib in Whole Blood and Plasma
1-15 days
Apparent Terminal Elimination Half-Life (t1/2) of [14C]-Poziotinib, Metabolites M1 and M2
1-15 days
t1/2 of Total Radioactivity of [14C]-Poziotinib in Whole Blood and Plasma
1-15 days
Elimination Rate Constant (λz, or kel) of [14C]-Poziotinib, Metabolites M1 and M2
1-15 days
λz, or kel of Total Radioactivity of [14C]-Poziotinib in Whole Blood and Plasma
1-15 days
Apparent Volume of Distribution (VZ/F) During Terminal Phase of [14C]-Poziotinib
1-15 days
Apparent Oral Clearance (CL/F) of [14C]-Poziotinib
1-15 days
Whole Blood : Plasma Concentration Ratios of Total Radioactivity of [14C]-Poziotinib
1-15 days
Total Radioactivity of Cumulative Amount Excreted in Urine (Aeu)
1-15 days
Total Radioactivity of Fraction of Dose Excreted in Urine (feu)
1-15 days
Total Radioactivity of Cumulative Amount Excreted in Feces (Aef)
1-15 days
Total Radioactivity of Fraction of Dose Excreted in Feces (fef)
1-15 days
Total Radioactivity of Cumulative Total Amount Excreted (Aetotal)
1-15 days
Total Radioactivity of Fraction of Dose Excreted in Urine and Feces (fetotal)
1-15 days
Poziotinib Metabolite Profiling and Identification in Plasma
1-15 days
Secondary Endpoints
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Screening, and up to 14 days post last dose of Poziotinib
Number of Participants With Clinically Significant Changes in Clinical Laboratory Parameters From Baseline
Screening, and up to 14 days post last dose of Poziotinib
Number of Participants With Clinically Significant Changes in 12-Lead Electrocardiogram (ECG) Findings From Baseline
Screening, and up to 14 days post last dose of Poziotinib
Unlock Study Endpoints
Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
Part 1: Itraconazole/Poziotinib Drug-drug interaction (DDI)EXPERIMENTALOn Day 1 of Treatment period 1, a single oral dose of 8 milligrams (mg) poziotinib will be administered. On Day 1 of Treatment Period 2, 200 mg itraconazole oral solution will be administered twice a day (BID) followed by 200 mg itraconazole oral solution once daily (QD) for 7 consecutive days (Day 2 to Day 8) with a single oral dose of 8 mg poziotinib coadministered on Day 4.
Part 2: Phenytoin/Poziotinib DDIEXPERIMENTALOn Day 1 of Treatment period 1, a single oral dose of 16 mg poziotinib will be administered. In treatment period 2, an oral dose of 100 mg phenytoin will be administered three times daily (TID) for 17 consecutive days (Day 1 to Day 17) with a single oral dose of 16 mg poziotinib coadministered on Day 14.
Part 3: Paroxetine/Poziotinib DDIEXPERIMENTALOn Day 1 of Treatment Period 1, a single oral dose of 8 mg poziotinib will be administered. On Day 1 and Day 2 of Treatment Period 2, an oral dose of 20 mg paroxetine will be administered BID followed by 20 mg paroxetine QD for 9 consecutive days (Day 3 to Day 11) with a single oral dose of 8 mg poziotinib coadministered on Day 7.
PoziotinibEXPERIMENTALA single oral dose of 8 mg poziotinib as a capsule formulation (as the hydrochloride salt) containing approximately 100 μCi of \[14C\]-poziotinib
Interventions
NameTypeDescription
PoziotinibDRUGPoziotinib Tablets
ItraconazoleDRUGItraconazole Oral solution
PhenytoinDRUGPhenytoin Capsules
ParoxetineDRUGParoxetine Tablets
[14C]-PoziotinibDRUGSingle oral administration of 8 mg (as the hydrocholoride salt) of \[14C\]-poziotinib
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Key Inclusion Criteria: * Healthy, adult, male or female (of non-childbearing potential only), 18-55 years of age. * Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kilogram per meter square (kg/m\^2) at screening, and a minimum weight of 50.0 kg and a maximum weight of 100.0 kg at screening. * Continuous ...

Countries:United States
Unlock Eligibility Criteria