Carcinoma, Non-Small-Cell LungPhase 1NCT01034748
A Radiolabeled Mass Balance Study Of [14C]PF-00299804 In Healthy Male Volunteers
A Phase 1 study testing [14C]PF00299804 in people with Carcinoma, Non-Small-Cell Lung, run by Pfizer at 1 site in United States.
Trial summary
This is single dose study of radiolabeled [14C]PF-00299804 in healthy male volunteers to study the absorption, distribution, metabolism and elimination of PF-00299804. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung
- What is being tested?
- [14C]PF00299804
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Feb 2010
- 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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male subjects between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG and clinical laboratory tests.)
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
- An informed consent document signed and dated by the subject.
- Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
Who cannot join
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
- Any condition possibly affecting drug absorption (eg, gastrectomy).
- A positive urine drug screen.
- History of regular alcohol consumption exceeding 14 drinks/week for males (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of screening.
- Use of tobacco- or nicotine-containing products within 3 months of screening or a positive urine cotinine test at Screening.
- Treatment with an investigational drug within 30 days (or as determined by the local requirement, whichever is longer) or 5 half lives preceding the first dose of study medication.
Show all 17Show fewer
- 12 lead ECG demonstrating QTc >450 msec at Screening. If QTc exceeds 450 msec, the ECG should be repeated two more times and the average of the three QTc values should be used to determine the subject's eligibility.
- Subjects enrolled in a previous radionucleotide study or who have received radiotherapy within 12 months prior to screening or such that total radioactivity would exceed acceptable dosimetry.
- Subjects whose occupation requires exposure to radiation or monitoring of radiation exposure.
- Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half lives (whichever is longer) prior to the first dose of study medication. Herbal supplements must be discontinued 28 days prior to the first dose of study medication. As an exception, acetaminophen/paracetamol may be used at doses of 1 g/day. Limited use of non prescription medications that are not believed to affect subject safety or the overall results of the study may be permitted on a case-by-case basis following approval by the sponsor.
- Blood donation of approximately 1 pint (500 mL) within 56 days prior to dosing.
- History of sensitivity to heparin or heparin-induced thrombocytopenia.
- Subject is the investigator or a sub investigator, research assistant, pharmacist, study coordinator, other staff, or a relative of study personnel directly involved with the conduct of the study.
- Subjects who are believed to be unable and/or unlikely to comprehend and follow the trial protocol.
- Subjects with a history of irregular bowel movements eg, regular episodes of diarrhea or constipation, irritable bowel syndrome (IBS) or lactose intolerance.
- Unwilling or unable to comply with the Lifestyle guidelines described in this protocol.
- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Pfizer Investigational Site
Tacoma, Washington, 98418
About this study
Official title: A Phase One Open-Label Single-Radiolabeled Dose Study To Investigate The Absorption, Metabolism And Excretion Of [14C]PF-00299804 in Healthy Male Volunteers
This is single dose study of radiolabeled [14C]PF-00299804 in healthy male volunteers to study the absorption, distribution, metabolism and elimination of PF-00299804.
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Being tested
- [14C]PF00299804
- Keywords
- Radiolabelled, Mass Balance, Healthy Volunteers, Pharmacokinetics
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[14C]PF00299804Drug
Single 45 mg oral dose of radiolabelled PF-00299804
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Single 45 mg oral dose of [14C]PF-00299804 Receives: Drug: [14C]PF00299804 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic parameters: Estimation of PK parameters (Cmax, Tmax, AUClast, AUCinf, t1/2, CL/F and Vd/F, as data permit) for PF 00299804, major metabolites (if possible), and total radioactivity.
Measured: 1 month
Mass balance: Calculation of % total recovery of total radioactivity in urine and feces; calculation of % dose excreted of major metabolites (if possible).
Measured: 1 month
Metabolic profiling / metabolite identification: Metabolic profile of PF 00299804 derived from plasma, urine and fecal samples; identification of major metabolites of PF-00299804 in plasma, urine and/or feces if possible.
Measured: 1 month
Secondary outcomes (1)
Safety laboratory tests, physical examination, vital signs, ECGs, concomitant medications and adverse event monitoring.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2009 (estimated)
- Study startJan 2010
- Primary completionFeb 2010
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Non-Small-Cell LungStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Syneos Health
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01034748
- Sponsor's protocol ID
- A7471020
- Status last verified
- Mar 2010
- First submitted
- 15 Dec 2009
- Last updated
- 12 Mar 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase One Open-Label Single-Radiolabeled Dose Study To Investigate The Absorption, Metabolism And Excretion Of [14C]PF-00299804 in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT01034748
- Acronym / sponsor ID
- A7471020
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Keywords
- Radiolabelled, Mass Balance, Healthy Volunteers, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Collaborators
- Syneos Health
- Study start
- Jan 2010
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 17 Dec 2009 (estimated)
- 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 is single dose study of radiolabeled [14C]PF-00299804 in healthy male volunteers to study the absorption, distribution, metabolism and elimination of PF-00299804.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: [14C]PF00299804Single 45 mg oral dose of [14C]PF-00299804 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male subjects between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG and clinical laboratory tests.)
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
- An informed consent document signed and dated by the subject.
- Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
Key exclusion criteria (17 listed)
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
- Any condition possibly affecting drug absorption (eg, gastrectomy).
- A positive urine drug screen.
- History of regular alcohol consumption exceeding 14 drinks/week for males (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of screening.
- Use of tobacco- or nicotine-containing products within 3 months of screening or a positive urine cotinine test at Screening.
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]PF00299804Single 45 mg oral dose of radiolabelled PF-00299804 | Drug | 1 |
Primary outcome
Pharmacokinetic parameters: Estimation of PK parameters (Cmax, Tmax, AUClast, AUCinf, t1/2, CL/F and Vd/F, as data permit) for PF 00299804, major metabolites (if possible), and total radioactivity.
Time frame: 1 month
Mass balance: Calculation of % total recovery of total radioactivity in urine and feces; calculation of % dose excreted of major metabolites (if possible).
Time frame: 1 month
Metabolic profiling / metabolite identification: Metabolic profile of PF 00299804 derived from plasma, urine and fecal samples; identification of major metabolites of PF-00299804 in plasma, urine and/or feces if possible.
Time frame: 1 month
1 secondary outcome
Safety laboratory tests, physical examination, vital signs, ECGs, concomitant medications and adverse event monitoring.
Time frame: 1 month
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 12 Mar 2010.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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.
Pfizer CT.gov Call Center study director
Pfizer
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]PF00299804 in people with Carcinoma, Non-Small-Cell Lung, run by Pfizer 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 4 inclusion and 17 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 12 Mar 2010. 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?
Pharmacokinetic parameters: Estimation of PK parameters (Cmax, Tmax, AUClast, AUCinf, t1/2, CL/F and Vd/F, as data permit) for PF 00299804, major metabolites (if possible), and total radioactivity. (time frame: 1 month). The study lists 3 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 12 Mar 2010.