HealthyPhase 1NCT04436562
Study of the Absorption, Metabolism, and Excretion Following a Single Dose of [14C]-Poziotinib in Healthy Male Subjects
A Phase 1 study testing [14C]-Poziotinib in people with Healthy, run by Spectrum Pharmaceuticals, Inc at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- [14C]-Poziotinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 29 May 2020to 17 Jul 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Covance Clinical Research Unit, Inc.
Madison, Wisconsin, 53704
About this study
Official title: 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
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.
Read the 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
- Being tested
- [14C]-Poziotinib
- Keywords
- Healthy Volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[14C]-PoziotinibDrug
Single oral administration of 8 mg (as the hydrocholoride salt) of [14C]-poziotinib
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: [14C]-Poziotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed Plasma Concentration (Cmax) of [14C]-Poziotinib, Metabolites M1 and M2
Measured: 1-15 days
Cmax of Total Radioactivity of [14C]-Poziotinib in Whole Blood and Plasma
Measured: 1-15 days
Time to Attain Maximum Observed Plasma Concentration (Tmax) of [14C]-Poziotinib, Metabolites M1 and M2
Measured: 1-15 days
Tmax of Total Radioactivity of [14C]-Poziotinib in Whole Blood and Plasma
Measured: 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
Measured: 1-15 days
AUC(last) of Total Radioactivity of [14C]-Poziotinib in Whole Blood and Plasma
Measured: 1-15 days
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUCinf) of [14C]-Poziotinib, Metabolites M1 and M2
Measured: 1-15 days
AUC(inf) of Total Radioactivity of [14C]-Poziotinib in Whole Blood and Plasma
Measured: 1-15 days
Percentage of AUCinf Derived by Extrapolation (%AUCext) of [14C]-Poziotinib, Metabolites M1 and M2
Measured: 1-15 days
%AUCext of Total Radioactivity of [14C]-Poziotinib in Whole Blood and Plasma
Measured: 1-15 days
Apparent Terminal Elimination Half-Life (t1/2) of [14C]-Poziotinib, Metabolites M1 and M2
Measured: 1-15 days
t1/2 of Total Radioactivity of [14C]-Poziotinib in Whole Blood and Plasma
Measured: 1-15 days
Elimination Rate Constant (λz, or kel) of [14C]-Poziotinib, Metabolites M1 and M2
Measured: 1-15 days
λz, or kel of Total Radioactivity of [14C]-Poziotinib in Whole Blood and Plasma
Measured: 1-15 days
Apparent Volume of Distribution (VZ/F) During Terminal Phase of [14C]-Poziotinib
Measured: 1-15 days
Apparent Oral Clearance (CL/F) of [14C]-Poziotinib
Measured: 1-15 days
Whole Blood : Plasma Concentration Ratios of Total Radioactivity of [14C]-Poziotinib
Measured: 1-15 days
Total Radioactivity of Cumulative Amount Excreted in Urine (Aeu)
Measured: 1-15 days
Total Radioactivity of Fraction of Dose Excreted in Urine (feu)
Measured: 1-15 days
Total Radioactivity of Cumulative Amount Excreted in Feces (Aef)
Measured: 1-15 days
Total Radioactivity of Fraction of Dose Excreted in Feces (fef)
Measured: 1-15 days
Total Radioactivity of Cumulative Total Amount Excreted (Aetotal)
Measured: 1-15 days
Total Radioactivity of Fraction of Dose Excreted in Urine and Feces (fetotal)
Measured: 1-15 days
Poziotinib Metabolite Profiling and Identification in Plasma
Measured: 1-15 days
Secondary outcomes (4)
Number of Participants with Adverse Events (AEs)
Measured: 1-15 days
Number of Participants with Hematology, Clinical Chemistry, Urinalysis Laboratory Abnormalities
Measured: 1-15 days
Number of Participants with 12-lead electrocardiograms (ECG) Abnormalities
Measured: 1-15 days
Number of Participants with Vital Sign and Physical Examinations Abnormalities
Measured: 1-15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2020
- Study start29 May 2020
- Primary completion17 Jul 2020
- Study completion17 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spectrum Pharmaceuticals, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shanta Chawla, MD, Study director, Spectrum Pharmaceuticals, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04436562
- Sponsor's protocol ID
- SPI-POZ-105
- Status last verified
- Jan 2021
- First submitted
- 11 Jun 2020
- Last updated
- 15 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04436562
- Acronym / sponsor ID
- SPI-POZ-105
- Conditions
- Healthy
- Keywords
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Spectrum Pharmaceuticals, IncIndustry (pharma, biotech, devices)
- Study start
- 29 May 2020 (actual)
- Primary completion
- 17 Jul 2020 (actual)
- Study completion
- 17 Jul 2020 (actual)
- First posted
- 18 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Poziotinib | Experimental | Drug: [14C]-PoziotinibA single oral dose of 8 mg poziotinib as a capsule formulation (as the hydrochloride salt) containing approximately 100 μCi of [14C]-poziotinib |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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 criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [14C]-PoziotinibSingle oral administration of 8 mg (as the hydrocholoride salt) of [14C]-poziotinib | Drug | Poziotinib |
Primary outcome
Maximum Observed Plasma Concentration (Cmax) of [14C]-Poziotinib, Metabolites M1 and M2
Time frame: 1-15 days
Cmax of Total Radioactivity of [14C]-Poziotinib in Whole Blood and Plasma
Time frame: 1-15 days
Time to Attain Maximum Observed Plasma Concentration (Tmax) of [14C]-Poziotinib, Metabolites M1 and M2
Time frame: 1-15 days
Tmax of Total Radioactivity of [14C]-Poziotinib in Whole Blood and Plasma
Time frame: 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
Time frame: 1-15 days
AUC(last) of Total Radioactivity of [14C]-Poziotinib in Whole Blood and Plasma
Time frame: 1-15 days
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUCinf) of [14C]-Poziotinib, Metabolites M1 and M2
Time frame: 1-15 days
AUC(inf) of Total Radioactivity of [14C]-Poziotinib in Whole Blood and Plasma
Time frame: 1-15 days
Percentage of AUCinf Derived by Extrapolation (%AUCext) of [14C]-Poziotinib, Metabolites M1 and M2
Time frame: 1-15 days
%AUCext of Total Radioactivity of [14C]-Poziotinib in Whole Blood and Plasma
Time frame: 1-15 days
Apparent Terminal Elimination Half-Life (t1/2) of [14C]-Poziotinib, Metabolites M1 and M2
Time frame: 1-15 days
t1/2 of Total Radioactivity of [14C]-Poziotinib in Whole Blood and Plasma
Time frame: 1-15 days
Elimination Rate Constant (λz, or kel) of [14C]-Poziotinib, Metabolites M1 and M2
Time frame: 1-15 days
λz, or kel of Total Radioactivity of [14C]-Poziotinib in Whole Blood and Plasma
Time frame: 1-15 days
Apparent Volume of Distribution (VZ/F) During Terminal Phase of [14C]-Poziotinib
Time frame: 1-15 days
Apparent Oral Clearance (CL/F) of [14C]-Poziotinib
Time frame: 1-15 days
Whole Blood : Plasma Concentration Ratios of Total Radioactivity of [14C]-Poziotinib
Time frame: 1-15 days
Total Radioactivity of Cumulative Amount Excreted in Urine (Aeu)
Time frame: 1-15 days
Total Radioactivity of Fraction of Dose Excreted in Urine (feu)
Time frame: 1-15 days
Total Radioactivity of Cumulative Amount Excreted in Feces (Aef)
Time frame: 1-15 days
Total Radioactivity of Fraction of Dose Excreted in Feces (fef)
Time frame: 1-15 days
Total Radioactivity of Cumulative Total Amount Excreted (Aetotal)
Time frame: 1-15 days
Total Radioactivity of Fraction of Dose Excreted in Urine and Feces (fetotal)
Time frame: 1-15 days
Poziotinib Metabolite Profiling and Identification in Plasma
Time frame: 1-15 days
4 secondary outcomes
Number of Participants with Adverse Events (AEs)
Time frame: 1-15 days
Number of Participants with Hematology, Clinical Chemistry, Urinalysis Laboratory Abnormalities
Time frame: 1-15 days
Number of Participants with 12-lead electrocardiograms (ECG) Abnormalities
Time frame: 1-15 days
Number of Participants with Vital Sign and Physical Examinations Abnormalities
Time frame: 1-15 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shanta Chawla, MD study director
Spectrum Pharmaceuticals, Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing [14C]-Poziotinib in people with Healthy, run by Spectrum Pharmaceuticals, Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Observed Plasma Concentration (Cmax) of [14C]-Poziotinib, Metabolites M1 and M2 (time frame: 1-15 days). The study lists 24 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2021.