HealthyPhase 1NCT01098877
First In Human Study Of Increasing Oral Doses Of PF-04634817
A Phase 1 study testing PF-04634817 in people with Healthy, run by Pfizer at 1 site in United States.
Trial summary
The study will evaluate the hypothesis that at doses and plasma concentrations which affect pharmacodynamic markers of activity at the chemokine receptors, CCR2 and CCR5, the compound is safe and well tolerated. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- PF-04634817
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to Sep 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male or female (of non-child bearing potential) subjects between 18 and 55 years of age.
- Body mass index of 17.5 to 30.5 kg/m2 and total body weight > 50kg.
Who cannot join
- Evidence or history of any clinically significant disease.
- Treatment with an investigational drug within 30 days of study start
- Use of prescription and non-prescription medicines within 7 days of study start
Trial locations and contacts
1 site in 1 country.
United States1 site
Pfizer Investigational Site
New Haven, Connecticut, 06511
About this study
Official title: A Double Blind, Randomized, Placebo Controlled, Dose Escalation Study To Investigate The Pharmacokinetics (In The Fed And Fasted State), Safety And Toleration Of Single Oral Doses Of PF-04634817 In Healthy Volunteers
The study will evaluate the hypothesis that at doses and plasma concentrations which affect pharmacodynamic markers of activity at the chemokine receptors, CCR2 and CCR5, the compound is safe and well tolerated. It will also evaluate the hypothesis that the pharmacokinetic profile is robust and consistent with a once or twice a day therapeutic administration.
- Conditions
- Healthy
- Being tested
- PF-04634817 Placebo, PF-04634817
- Keywords
- Phase1, pharmacokinetics, safety, toleration, pharmacodynamics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-04634817 PlaceboDrug
Oral solution, placebo, single dose
PF-04634817Drug
Oral solution, 1mg, single dose
PF-04634817Drug
Oral solution, 3mg, single dose
PF-04634817Drug
Oral solution, 10mg, single dose
PF-04634817Drug
Oral solution, 30mg, single dose
PF-04634817Drug
Oral solution, 100mg, single dose
PF-04634817Drug
Oral solution, 300mg, single dose
PF-04634817Drug
Oral solution, 600mg, single dose
PF-04634817Drug
Oral solution, 900mg, single dose
PF-04634817Drug
Oral solution, up to 900mg, single dose after food
PF-04634817 PlaceboDrug
Oral solution, placebo, single dose after food
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: PF-04634817 Placebo |
| Cohort 1, 1mg | Experimental | Not described Receives: Drug: PF-04634817 |
| Cohort 1, 3mg | Experimental | Not described Receives: Drug: PF-04634817 |
| Cohort 1, 10mg | Experimental | Not described Receives: Drug: PF-04634817 |
| Cohort 2, 30mg | Experimental | Not described Receives: Drug: PF-04634817 |
| Cohort 2, 100mg | Experimental | Not described Receives: Drug: PF-04634817 |
| Cohort 2, 300mg | Experimental | Not described Receives: Drug: PF-04634817 |
| Cohort 3, 600mg | Experimental | Not described Receives: Drug: PF-04634817 |
| Cohort 3, 900mg | Experimental | Not described Receives: Drug: PF-04634817 |
| Cohort 3, up to 900mg (fed) | Experimental | Not described Receives: Drug: PF-04634817 |
| Cohort 3, placebo (fed) | Placebo comparator | Not described Receives: Drug: PF-04634817 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and toleration: adverse events, supine and standing vital sign measurements, telemetry, 12-lead ECGs, blood and urine tests
Measured: 0-3 days
Plasma pharmacokinetics: Cmax, Tmax, AUClast, AUCinf, AUC0-24, CL/F, Vz/F and T1/2
Measured: 0-4 days
Urinary pharmacokinetics: Aet (mount excreted in urine), Aet% and CLr
Measured: 0-2 days
p-ERK inhibition in human monocytes
Measured: 0-3 days
Change in circulating monocytes
Measured: 0-3 days
Secondary outcomes (3)
Change from baseline in plasma MCP-1
Measured: 0-3 days
MIP 1B stimulated CCR5 receptor internalization
Measured: 0-3 days
MCP-1 stimulated CCR5 receptor internalization
Measured: 0-3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2010 (estimated)
- Study startApr 2010
- Primary completionSep 2010
- Study completionSep 2010
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 27 participants (actual)
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
- NCT01098877
- Sponsor's protocol ID
- B1261002
- Status last verified
- Oct 2010
- First submitted
- 26 Mar 2010
- Last updated
- 13 Oct 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind, Randomized, Placebo Controlled, Dose Escalation Study To Investigate The Pharmacokinetics (In The Fed And Fasted State), Safety And Toleration Of Single Oral Doses Of PF-04634817 In Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01098877
- Acronym / sponsor ID
- B1261002
- Conditions
- Healthy
- Keywords
- Phase1, pharmacokinetics, safety, toleration, pharmacodynamics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Apr 2010
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 5 Apr 2010 (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 study will evaluate the hypothesis that at doses and plasma concentrations which affect pharmacodynamic markers of activity at the chemokine receptors, CCR2 and CCR5, the compound is safe and well tolerated. It will also evaluate the hypothesis that the pharmacokinetic profile is robust and consistent with a once or twice a day therapeutic administration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 11
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PF-04634817 Placebo |
| Cohort 1, 1mg | Experimental | Drug: PF-04634817 |
| Cohort 1, 3mg | Experimental | Drug: PF-04634817 |
| Cohort 1, 10mg | Experimental | Drug: PF-04634817 |
| Cohort 2, 30mg | Experimental | Drug: PF-04634817 |
| Cohort 2, 100mg | Experimental | Drug: PF-04634817 |
| Cohort 2, 300mg | Experimental | Drug: PF-04634817 |
| Cohort 3, 600mg | Experimental | Drug: PF-04634817 |
| Cohort 3, 900mg | Experimental | Drug: PF-04634817 |
| Cohort 3, up to 900mg (fed) | Experimental | Drug: PF-04634817 |
| Cohort 3, placebo (fed) | Placebo comparator | Drug: PF-04634817 Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy male or female (of non-child bearing potential) subjects between 18 and 55 years of age.
- Body mass index of 17.5 to 30.5 kg/m2 and total body weight > 50kg.
Key exclusion criteria (3 listed)
- Evidence or history of any clinically significant disease.
- Treatment with an investigational drug within 30 days of study start
- Use of prescription and non-prescription medicines within 7 days of study start
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 |
|---|---|---|
| PF-04634817 PlaceboOral solution, placebo, single dose | Drug | Placebo |
| PF-04634817Oral solution, 1mg, single dose | Drug | Cohort 1, 1mg |
| PF-04634817Oral solution, 3mg, single dose | Drug | Cohort 1, 3mg |
| PF-04634817Oral solution, 10mg, single dose | Drug | Cohort 1, 10mg |
| PF-04634817Oral solution, 30mg, single dose | Drug | Cohort 2, 30mg |
| PF-04634817Oral solution, 100mg, single dose | Drug | Cohort 2, 100mg |
| PF-04634817Oral solution, 300mg, single dose | Drug | Cohort 2, 300mg |
| PF-04634817Oral solution, 600mg, single dose | Drug | Cohort 3, 600mg |
| PF-04634817Oral solution, 900mg, single dose | Drug | Cohort 3, 900mg |
| PF-04634817Oral solution, up to 900mg, single dose after food | Drug | Cohort 3, up to 900mg (fed) |
| PF-04634817 PlaceboOral solution, placebo, single dose after food | Drug | Cohort 3, placebo (fed) |
Primary outcome
Safety and toleration: adverse events, supine and standing vital sign measurements, telemetry, 12-lead ECGs, blood and urine tests
Time frame: 0-3 days
Plasma pharmacokinetics: Cmax, Tmax, AUClast, AUCinf, AUC0-24, CL/F, Vz/F and T1/2
Time frame: 0-4 days
Urinary pharmacokinetics: Aet (mount excreted in urine), Aet% and CLr
Time frame: 0-2 days
p-ERK inhibition in human monocytes
Time frame: 0-3 days
Change in circulating monocytes
Time frame: 0-3 days
3 secondary outcomes
Change from baseline in plasma MCP-1
Time frame: 0-3 days
MIP 1B stimulated CCR5 receptor internalization
Time frame: 0-3 days
MCP-1 stimulated CCR5 receptor internalization
Time frame: 0-3 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 13 Oct 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 PF-04634817 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 2 inclusion and 3 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 13 Oct 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. Some participants in this study may receive a placebo. 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?
Safety and toleration: adverse events, supine and standing vital sign measurements, telemetry, 12-lead ECGs, blood and urine tests (time frame: 0-3 days). The study lists 5 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 13 Oct 2010.