HCVPhase 1NCT00823745

Radiolabel ADME (Absorption, Distribution, Metabolism, and Excretion) Study Of [14C] PF-00868554 In Healthy Adult Male Subjects

A Phase 1 study testing [14C]-PF-00868554 in people with HCV, run by Pfizer at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This is a phase 1 study to assess the routes of elimination of a single oral dose of [14C] PF-00868554 and to characterize the metabolic profile following single dose administration. Read more about this study

Who is it for?: Ages 18 to 45 years, men onlyHealthy volunteers can take part
Conditions the study is for: HCV
What is being tested?: [14C]-PF-00868554
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 7 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 18 to 45 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

Male, healthy volunteers.

Who cannot join

Females.

Trial locations and contacts

1 site in 1 country.

United States1 site

Pfizer Investigational Site
Tacoma, Washington, 98415

Other trials in United States

About this study

Official title: A Phase 1 Study To Evaluate The Metabolism And Excretion Of [14C] PF-00868554 In Healthy Adult Male Subjects

This is a phase 1 study to assess the routes of elimination of a single oral dose of [14C] PF-00868554 and to characterize the metabolic profile following single dose administration.

Conditions: HCV
Being tested: [14C]-PF-00868554

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

[14C]-PF-00868554Drug
solution, single dose

Study groups in NCT00823745
Study group	Role	What they receive
1	Experimental	[14C]-PF-00868554 Receives: Drug: [14C]-PF-00868554

What is being measured

The primary outcome is the main question the study is designed to answer.

The amount of radioactivity recovered in urine and feces, as a percent of the dose.
Measured: 7 weeks
The amount of PF-00868554, expressed as a percent of total radioactivity, in plasma, urine, and feces.
Measured: 7 weeks
Identification and determination of relative abundance of the metabolites of PF-00868554 in plasma, urine, and feces.
Measured: 7 weeks
PK parameters: AUClast, AUCinf, maximum concentration (Cmax), time of maximum concentration (Tmax), and half-life (t1/2) to describe the single dose PK of a) total radioactivity in blood; b) total radioactivity in plasma; c) PF-00868554 in plasma.
Measured: 7 weeks

Secondary outcomes (1)

Safety endpoints including adverse events, clinical laboratory tests, vital signs and ECGs.
Measured: 7 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2009Feb 2009

First posted16 Jan 2009 (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 HCVStudies 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: 7 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00823745
Sponsor's protocol ID: A8121013
Status last verified: Mar 2009
First submitted: 7 Jan 2009
Last updated: 9 Mar 2009
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All HCV trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1 Study To Evaluate The Metabolism And Excretion Of [14C] PF-00868554 In Healthy Adult Male Subjects
ClinicalTrials.gov ID: NCT00823745
Acronym / sponsor ID: A8121013
Conditions: HCV
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 7 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Jan 2009
Primary completion: Feb 2009 (actual)
Study completion: Feb 2009 (actual)
First posted: 16 Jan 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 a phase 1 study to assess the routes of elimination of a single oral dose of [14C] PF-00868554 and to characterize the metabolic profile following single dose administration.

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]-PF-00868554[14C]-PF-00868554

Who may qualify

Ages: 18 to 45 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (1 listed)

Male, healthy volunteers.

Key exclusion criteria (1 listed)

Females.

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]-PF-00868554solution, single dose	Drug	1

Primary outcome

The amount of radioactivity recovered in urine and feces, as a percent of the dose.
Time frame: 7 weeks
The amount of PF-00868554, expressed as a percent of total radioactivity, in plasma, urine, and feces.
Time frame: 7 weeks
Identification and determination of relative abundance of the metabolites of PF-00868554 in plasma, urine, and feces.
Time frame: 7 weeks
PK parameters: AUClast, AUCinf, maximum concentration (Cmax), time of maximum concentration (Tmax), and half-life (t1/2) to describe the single dose PK of a) total radioactivity in blood; b) total radioactivity in plasma; c) PF-00868554 in plasma.
Time frame: 7 weeks

1 secondary outcome

Safety endpoints including adverse events, clinical laboratory tests, vital signs and ECGs.
Time frame: 7 weeks

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 9 Mar 2009.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

Related trials for HCV

RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Not yet recruiting
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HIV Testing, STI
Not yet recruitingObservational study
Elimination of Hepatitis C Virus Among Users of Substances
Hepatitis C in Substance Users
Not yet recruiting
Clinical Study to Evaluate the Performance of the INSTI® HCV Antibody Test for CLIA-Waived Use
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Not yet recruiting
Study to Evaluate the Performance of the INSTI® HCV Antibody Test for Point-of-Care Use in Individuals at Risk for HCV Infection or Presenting With Signs or Symptoms of HCV Infection
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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]-PF-00868554 in people with HCV, 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 9 Mar 2009. 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?

The amount of radioactivity recovered in urine and feces, as a percent of the dose. (time frame: 7 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00823745.

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 9 Mar 2009.