Status:
COMPLETED
Study of the Absorption, Metabolism, and Excretion Following a Single Dose of [14C]-Poziotinib in Healthy Male Subjects
Lead Sponsor:
Spectrum Pharmaceuticals, Inc
Conditions:
Healthy
Eligibility:
MALE
18-65 years
Phase:
PHASE1
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\...
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 D...
Eligibility Criteria
Inclusion
- Key
- 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
Exclusion
- 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
Key Trial Info
Start Date :
May 29 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 17 2020
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT04436562
Start Date
May 29 2020
End Date
July 17 2020
Last Update
January 15 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Covance Clinical Research Unit, Inc.
Madison, Wisconsin, United States, 53704