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

NCT04436562 | Completed Phase 1 FDA Drug

• 1 other identifier: SPI-POZ-105
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Healthy Volunteers

Outcome Measures

Primary Outcomes (24)

• 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 Outcomes (4)

• Number of Participants with Adverse Events (AEs)

  1-15 days

• 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

Study Arms (1)

Poziotinib

EXPERIMENTAL

A single oral dose of 8 mg poziotinib as a capsule formulation (as the hydrochloride salt) containing approximately 100 μCi of \[14C\]-poziotinib

Drug: [14C]-Poziotinib

Interventions

[14C]-Poziotinib DRUG

Single oral administration of 8 mg (as the hydrocholoride salt) of \[14C\]-poziotinib

Poziotinib

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Spectrum Pharmaceuticals, Inc: lead

Study Sites (1)

Covance Clinical Research Unit, Inc.

Madison, Wisconsin, 53704, United States

Location

Study Officials

• Shanta Chawla, MD

  Spectrum Pharmaceuticals, Inc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2020
• First Posted: June 18, 2020
• Study Start: May 29, 2020
• Primary Completion: July 17, 2020
• Study Completion: July 17, 2020
• Last Updated: January 15, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)