NCT04436562

Study of the Absorption, Metabolism, and Excretion Following a Single Dose of [14C]-Poziotinib in Healthy Male Subjects

Phase 1 Open-label Study of the Absorption, Metabolism, and Excretion of Poziotinib Following a Single Oral Dose of [14C]-Poziotinib in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Spectrum Pharmaceuticals, Inc · Industry
• Sex: Male
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	[14C]-Poziotinib	Single oral administration of 8 mg (as the hydrocholoride salt) of \[14C\]-poziotinib

Timeline

• Start date: 2020-05-29
• Primary completion: 2020-07-17
• Completion: 2020-07-17
• First posted: 2020-06-18
• Last updated: 2021-01-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study