HealthyPhase 1ADMENCT00800956
Phase I Study to Determine the Absorption, Distribution, Metabolism and Excretion of Esreboxetine
A Phase 1 study testing [14C]-esreboxetine in people with Healthy, run by Pfizer at 1 site in United States.
Trial summary
The purpose of the study is to learn more about how esreboxetine is handled by the body i.e. the absorption, metabolism and excretion of esreboxetine. Read more about this study
- Who is it for?
- Ages 45 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- [14C]-esreboxetine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Feb 2009
- 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 45 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy male subjects aged 45 to 65 years Body mass index (BMI=weight/height2) 18 to 30 kg/m2
Who cannot join
- Any clinically relevant abnormality identified on the screening medical assessment Any condition possibly affecting drug absorption Subjects with exposure to significant radiation (eg serial Xray or CT scans, barium meal etc)or who have participated in a radiolabelled study in the past 12 months, or who have occupational exposure to radioactivity History of regular alcohol consumption exceeding 14 drinks/week (1 drink = 5ounces (150ml) of wine or 12 ounces (360ml) of beer or 1.5 ounces (45ml) of hard liquor) within 6 months of screening 12-lead ECG demonstrating QTc>450mses at screening Treatment with an investigational drug within 30 days or 5 half-lives preceding the first dose of study medication
Trial locations and contacts
1 site in 1 country.
United States1 site
Pfizer Investigational Site
Tacoma, Washington, 98415
About this study
Official title: An Open Label, Single Oral Dose Study to Investigate the Absorption, Metabolism and Excretion of [14C]-Esreboxetine.
The purpose of the study is to learn more about how esreboxetine is handled by the body i.e. the absorption, metabolism and excretion of esreboxetine.
- Conditions
- Healthy
- Being tested
- [14C]-esreboxetine
- Keywords
- Radiolabel ADME study Healthy volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[14C]-esreboxetineDrug
Single oral dose of 6mg esreboxetine in solution containing approximately 100uCi [14C]-esreboxetine
| Study group | Role | What they receive |
|---|---|---|
| Single oral dose of [14C]-esreboxetine | Experimental | Not described Receives: Drug: [14C]-esreboxetine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative excretion of radioactivity in urine and and faeces as a percentage of the total radioactive dose administered over time. Collection of plasma, urine and faeces for the assessment of parent drug and metabolites of esreboxetine where possible
Measured: Approx 10 days
Pharmacokinetic parameters of esreboxetine and identification and abundance of metabolites in plasma, urine and faeces if possible
Measured: Approx 10 days
Secondary outcomes (2)
Clinical safety data
Measured: Approx 10 days
Pharmacokinetic parameters of plasma esreboxetine metabolites if possible
Measured: Approx 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2008 (estimated)
- Study startJan 2009
- Primary completionFeb 2009
- Study completionFeb 2009
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.
- 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
- 4 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00800956
- Sponsor's protocol ID
- A6061018
- Acronym
- ADME
- Status last verified
- Apr 2011
- First submitted
- 2 Dec 2008
- Last updated
- 7 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Single Oral Dose Study to Investigate the Absorption, Metabolism and Excretion of [14C]-Esreboxetine.
- ClinicalTrials.gov ID
- NCT00800956
- Acronym / sponsor ID
- ADME / A6061018
- Conditions
- Healthy
- Keywords
- Radiolabel ADME study Healthy volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (estimated)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jan 2009
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 3 Dec 2008 (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.
The purpose of the study is to learn more about how esreboxetine is handled by the body i.e. the absorption, metabolism and excretion of esreboxetine.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single oral dose of [14C]-esreboxetine | Experimental | Drug: [14C]-esreboxetine |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy male subjects aged 45 to 65 years Body mass index (BMI=weight/height2) 18 to 30 kg/m2
Key exclusion criteria (1 listed)
- Any clinically relevant abnormality identified on the screening medical assessment Any condition possibly affecting drug absorption Subjects with exposure to significant radiation (eg serial Xray or CT scans, barium meal etc)or who have participated in a radiolabelled study in the past 12 months, or who have occupational exposure to radioactivity History of regular alcohol consumption exceeding 14 drinks/week (1 drink = 5ounces (150ml) of wine or 12 ounces (360ml) of beer or 1.5 ounces (45ml) of hard liquor) within 6 months of screening 12-lead ECG demonstrating QTc>450mses at screening Treatment with an investigational drug within 30 days or 5 half-lives preceding the first dose of study medication
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]-esreboxetineSingle oral dose of 6mg esreboxetine in solution containing approximately 100uCi [14C]-esreboxetine | Drug | Single oral dose of [14C]-esreboxetine |
Primary outcome
Cumulative excretion of radioactivity in urine and and faeces as a percentage of the total radioactive dose administered over time. Collection of plasma, urine and faeces for the assessment of parent drug and metabolites of esreboxetine where possible
Time frame: Approx 10 days
Pharmacokinetic parameters of esreboxetine and identification and abundance of metabolites in plasma, urine and faeces if possible
Time frame: Approx 10 days
2 secondary outcomes
Clinical safety data
Time frame: Approx 10 days
Pharmacokinetic parameters of plasma esreboxetine metabolites if possible
Time frame: Approx 10 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 7 Apr 2011.
- 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]-esreboxetine in people with Healthy, 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 1 inclusion and 1 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 7 Apr 2011. 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?
Cumulative excretion of radioactivity in urine and and faeces as a percentage of the total radioactive dose administered over time. Collection of plasma, urine and faeces for the assessment of parent drug and metabolites of esreboxetine where possible (time frame: Approx 10 days). The study lists 2 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 7 Apr 2011.