Study of the Absorption, Metabolism, and Excretion Following a Single Dose of [14C]-Poziotinib in Healthy Male Subjects
- Conditions
- Healthy
- Interventions
- Drug: [14C]-Poziotinib
- Registration Number
- NCT04436562
- Lead Sponsor
- Spectrum Pharmaceuticals, Inc
- Brief Summary
This will be a Phase 1, open-label, nonrandomized, single-dose study in healthy male subjects to evaluate the Absorption, Metabolism, and Excretion of Poziotinib following a single oral dose of \[14C\]-poziotinib to healthy male subjects.
- Detailed Description
Potential subjects will be screened to assess their eligibility to enter the study within 28 days prior to the dose administration. Subjects will be admitted into the Clinical Research Unit (CRU) on Day -1. On the morning of Day 1, all subjects will receive a single oral dose of 8 mg (as the hydrochloride salt) containing approximately 100 μCi of \[14C\]-poziotinib in the fasted state.
Subjects will be confined to the CRU until at least Day 8.
Subjects will be discharged from the CRU on Day 8 if the following criteria are met:
* ≥90% mass balance recovery in combined urine and feces, and
* ≤1% of the total radioactive dose is recovered in combined excreta (urine and feces) in 2 consecutive 24-hour periods in which fecal and urine samples are obtained.
If these criteria are not met by Day 8, subjects will remain in the CRU until all discharge criteria are met up to a maximum of Day 15 in order to continue 24-hour blood, urine, and feces collections, unless otherwise agreed upon by the Sponsor and Investigator.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 8
- Body mass index between 18.0 and 32.0 kg/m2, inclusive
- In good health at Screening and/or at Check-in
- Subjects must be surgically sterile for at least 90 days, or when sexually active with female partners of childbearing and non-childbearing potential will be required to use a male condom with spermicide from CRU Check-in until 90 days after discharge. Subjects are required to refrain from donation of sperm from CRU Check-in until 90 days after discharge
- Able to comprehend and willing to sign an ICF and to abide by the study restrictions
- History of at least 1 bowel movement per day
Key
- Stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs
- Swallowing difficulties or ongoing diarrhea of any etiology
- Participation in a clinical study involving an investigational drug in the past 30 days prior to dosing
- Use or intend to use any medications/products known to alter drug absorption, metabolism, or elimination processes, including St. John's wort, within 30 days prior to Check-in
- Use or intend to use any prescription medications/products within 14 days prior to Check-in
- Use or intend to use slow-release medications/products considered to still be active within 14 days prior to Check-in
- Exposure to significant diagnostic or therapeutic radiation or current employment in a job requiring radiation exposure monitoring within 12 months prior to Check-in
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Poziotinib [14C]-Poziotinib A single oral dose of 8 mg poziotinib as a capsule formulation (as the hydrochloride salt) containing approximately 100 μCi of \[14C\]-poziotinib
- Primary Outcome Measures
Name Time Method 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 Last Quantifiable Concentration (AUC[last]) of [14C]-Poziotinib, Metabolites M1 and M2 1-15 days Maximum Observed Plasma Concentration (Cmax) 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 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 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 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 λz, or kel of Total Radioactivity of [14C]-Poziotinib in Whole Blood and Plasma 1-15 days Total Radioactivity of Fraction of Dose Excreted in Urine and Feces (fetotal) 1-15 days Apparent Terminal Elimination Half-Life (t1/2) of [14C]-Poziotinib, Metabolites M1 and M2 1-15 days Total Radioactivity of Cumulative Amount Excreted in Feces (Aef) 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 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 Fraction of Dose Excreted in Feces (fef) 1-15 days Total Radioactivity of Cumulative Total Amount Excreted (Aetotal) 1-15 days Poziotinib Metabolite Profiling and Identification in Plasma 1-15 days
- Secondary Outcome Measures
Name Time Method Number of Participants with Hematology, Clinical Chemistry, Urinalysis Laboratory Abnormalities 1-15 days Number of Participants with 12-lead electrocardiograms (ECG) Abnormalities 1-15 days Number of Participants with Vital Sign and Physical Examinations Abnormalities 1-15 days Number of Participants with Adverse Events (AEs) 1-15 days
Trial Locations
- Locations (1)
Covance Clinical Research Unit, Inc.
🇺🇸Madison, Wisconsin, United States