Respiratory Tract InfectionsPhase 1NCT00793000
Safety And Pharmacokinetics Study Of PF-04287881 In Healthy Adults
A Phase 1 study testing PF-04287881 in people with Respiratory Tract Infections, run by Pfizer at 1 site in United States.
Trial summary
The purpose of this study is to determine the safety, tolerability and pharmacokinetics of PF-04287881 after a single oral dose in healthy adult volunteers. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Respiratory Tract Infections
- What is being tested?
- PF-04287881
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2008to Dec 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Volunteers willing and able to be confined to the Clinical Research Unit and comply with study schedule.
- Women of non-childbearing potential only.
- Japanese subjects muct have 4 Japanese grandparents who were born in Japan.
Who cannot join
- Previous antibiotic use within 14 days prior to dosing.
- Use of antibiotics during hospitalization within 90 days prior to dosing.
- History of sensitivity to macrolides or ketolides.
- Presence of clinically significant eye conditions (other than corrective lenses).
Trial locations and contacts
1 site in 1 country.
United States1 site
Pfizer Investigational Site
New Haven, Connecticut, 06511-5473
About this study
Official title: A Phase 1 Study To Evaluate The Safety, Tolerability, And Pharmacokinetics Of PF-04287881 After First Time Administration Of Ascending Single Oral Doses To Healthy Adult Subjects
The purpose of this study is to determine the safety, tolerability and pharmacokinetics of PF-04287881 after a single oral dose in healthy adult volunteers.
- Conditions
- Respiratory Tract Infections
- Being tested
- PF-04287881, Placebo
- Keywords
- Safety tolerability pharmacokinetics PK first in human FIH
- Medical subject headings
- Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-04287881Drug
75 mg oral dose (prepared solution) given once
PlaceboDrug
placebo to match 75 mg oral dose (prepared solution), given once
PF-04287881Drug
150 mg oral dose (prepared solution) given once
PlaceboDrug
placebo to match 150 mg oral dose (prepared solution), given once
PF-04287881Drug
300 mg oral dose (prepared solution) given once
PlaceboDrug
placebo to match 300 mg oral dose (prepared solution), given once
PF-04287881Drug
750 mg oral dose (prepared solution) given once
PlaceboDrug
placebo to match 750 mg oral dose (prepared solution), given once
PF-04287881Drug
1000 mg oral dose (prepared solution) given once
PlaceboDrug
placebo to match 1000 mg oral dose (prepared solution), given once
PF-04287881Drug
1250 mg oral dose (prepared solution) given once
PlaceboDrug
placebo to match 1250 mg oral dose (prepared solution), given once
PF-04287881Drug
1500 mg oral dose (prepared solution) given once
PlaceboDrug
placebo to match 1500 mg oral dose (prepared solution), given once
PF-04287881Drug
300 mg oral dose (prepared solution) given once
PlaceboDrug
placebo to match 300 mg oral dose (prepared solution), given once
PF-04287881Drug
750 mg oral dose (prepared solution) given once
PlaceboDrug
placebo to match 750 mg oral dose (prepared solution), given once
PF-04287881Drug
1000 mg based on safety and PK from previous cohorts; oral dose (prepared solution) given once
PlaceboDrug
placebo to match 1000 mg oral dose (prepared solution), given once
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Not described Receives: Drug: PF-04287881; Drug: Placebo |
| Cohort 2 | Experimental | Not described Receives: Drug: PF-04287881; Drug: Placebo |
| Cohort 3 | Experimental | Not described Receives: Drug: PF-04287881; Drug: Placebo |
| Cohort 4 | Experimental | Not described Receives: Drug: PF-04287881; Drug: Placebo |
| Cohort 5 | Experimental | Not described Receives: Drug: PF-04287881; Drug: Placebo |
| Cohort 6 | Experimental | Not described Receives: Drug: PF-04287881; Drug: Placebo |
| Cohort 7 | Experimental | Not described Receives: Drug: PF-04287881; Drug: Placebo |
| Cohort 8 | Experimental | Japanese volunteers, low dose previously tested (based on PK) Receives: Drug: PF-04287881; Drug: Placebo |
| Cohort 9 | Experimental | Japanese volunteers, intermediate dose previously tested (based on PK) Receives: Drug: PF-04287881; Drug: Placebo |
| Cohort 10 | Experimental | Japanese volunteers, high dose previously tested (based on safety) Receives: Drug: PF-04287881; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of safety and tolerability of PF-04287881 after single oral dose.
Measured: Daily up to discharge, follow-up 7-10 days after dosing
Secondary outcomes (1)
Pharmacokinetics of PF-04287881 after a single oral dose.
Measured: Pre-dose; Multiple timepoints on Day 1; 24, 36 hours Day 2; Single sample on Days 3-7.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2008 (estimated)
- Study startNov 2008
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Tract InfectionsStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 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
- NCT00793000
- Sponsor's protocol ID
- B0581001
- Status last verified
- May 2011
- First submitted
- 12 Nov 2008
- Last updated
- 4 May 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study To Evaluate The Safety, Tolerability, And Pharmacokinetics Of PF-04287881 After First Time Administration Of Ascending Single Oral Doses To Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT00793000
- Acronym / sponsor ID
- B0581001
- Conditions
- Respiratory Tract Infections
- Keywords
- Safety tolerability pharmacokinetics PK first in human FIH
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Nov 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 18 Nov 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 this study is to determine the safety, tolerability and pharmacokinetics of PF-04287881 after a single oral dose in healthy adult volunteers.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: PF-04287881, Drug: Placebo |
| Cohort 2 | Experimental | Drug: PF-04287881, Drug: Placebo |
| Cohort 3 | Experimental | Drug: PF-04287881, Drug: Placebo |
| Cohort 4 | Experimental | Drug: PF-04287881, Drug: Placebo |
| Cohort 5 | Experimental | Drug: PF-04287881, Drug: Placebo |
| Cohort 6 | Experimental | Drug: PF-04287881, Drug: Placebo |
| Cohort 7 | Experimental | Drug: PF-04287881, Drug: Placebo |
| Cohort 8 | Experimental | Drug: PF-04287881, Drug: PlaceboJapanese volunteers, low dose previously tested (based on PK) |
| Cohort 9 | Experimental | Drug: PF-04287881, Drug: PlaceboJapanese volunteers, intermediate dose previously tested (based on PK) |
| Cohort 10 | Experimental | Drug: PF-04287881, Drug: PlaceboJapanese volunteers, high dose previously tested (based on safety) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Volunteers willing and able to be confined to the Clinical Research Unit and comply with study schedule.
- Women of non-childbearing potential only.
- Japanese subjects muct have 4 Japanese grandparents who were born in Japan.
Key exclusion criteria (4 listed)
- Previous antibiotic use within 14 days prior to dosing.
- Use of antibiotics during hospitalization within 90 days prior to dosing.
- History of sensitivity to macrolides or ketolides.
- Presence of clinically significant eye conditions (other than corrective lenses).
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-0428788175 mg oral dose (prepared solution) given once | Drug | Cohort 1 |
| Placeboplacebo to match 75 mg oral dose (prepared solution), given once | Drug | Cohort 1 |
| PF-04287881150 mg oral dose (prepared solution) given once | Drug | Cohort 2 |
| Placeboplacebo to match 150 mg oral dose (prepared solution), given once | Drug | Cohort 2 |
| PF-04287881300 mg oral dose (prepared solution) given once | Drug | Cohort 3 |
| Placeboplacebo to match 300 mg oral dose (prepared solution), given once | Drug | Cohort 3 |
| PF-04287881750 mg oral dose (prepared solution) given once | Drug | Cohort 4 |
| Placeboplacebo to match 750 mg oral dose (prepared solution), given once | Drug | Cohort 4 |
| PF-042878811000 mg oral dose (prepared solution) given once | Drug | Cohort 5 |
| Placeboplacebo to match 1000 mg oral dose (prepared solution), given once | Drug | Cohort 5 |
| PF-042878811250 mg oral dose (prepared solution) given once | Drug | Cohort 6 |
| Placeboplacebo to match 1250 mg oral dose (prepared solution), given once | Drug | Cohort 6 |
| PF-042878811500 mg oral dose (prepared solution) given once | Drug | Cohort 7 |
| Placeboplacebo to match 1500 mg oral dose (prepared solution), given once | Drug | Cohort 7 |
| PF-04287881300 mg oral dose (prepared solution) given once | Drug | Cohort 8 |
| Placeboplacebo to match 300 mg oral dose (prepared solution), given once | Drug | Cohort 8 |
| PF-04287881750 mg oral dose (prepared solution) given once | Drug | Cohort 9 |
| Placeboplacebo to match 750 mg oral dose (prepared solution), given once | Drug | Cohort 9 |
| PF-042878811000 mg based on safety and PK from previous cohorts; oral dose (prepared solution) given once | Drug | Cohort 10 |
| Placeboplacebo to match 1000 mg oral dose (prepared solution), given once | Drug | Cohort 10 |
Primary outcome
Evaluation of safety and tolerability of PF-04287881 after single oral dose.
Time frame: Daily up to discharge, follow-up 7-10 days after dosing
1 secondary outcome
Pharmacokinetics of PF-04287881 after a single oral dose.
Time frame: Pre-dose; Multiple timepoints on Day 1; 24, 36 hours Day 2; Single sample on Days 3-7.
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 4 May 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 PF-04287881 in people with Respiratory Tract Infections, 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 3 inclusion and 4 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 4 May 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?
Evaluation of safety and tolerability of PF-04287881 after single oral dose. (time frame: Daily up to discharge, follow-up 7-10 days after dosing). 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 4 May 2011.