Healthy VolunteersPhase 1NCT00990015
A Phase 1 Single-Dose Escalation Study of PF-04308515 in Healthy Volunteers
A Phase 1 study testing PF-04308515 in people with Healthy Volunteers, run by Pfizer at 1 site in United States.
Trial summary
The purpose of this study is to determine the safety, tolerability, pharmacokinetics (understanding how a drug is absorbed and moves through the body) and pharmacodynamics (understanding the effects of a drug on certain target sites of activity in the body). Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- PF-04308515
- 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
- Oct 2009to Jan 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 males between 18 and 55 years, inclusive
- Healthy females between 18 and 44 years, inclusive.
- Women need to be surgically sterile
Who cannot join
- Evidence or history of clinically significant disease
- Post-menopausal women
- History of intolerance or significant adverse effects with glucocorticoids
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 Phase 1, Randomized, Double-Blind, Sponsor-Open, Placebo-Controlled, Single-Dose Escalation Trial Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PF-04308515 in Healthy Volunteers
The purpose of this study is to determine the safety, tolerability, pharmacokinetics (understanding how a drug is absorbed and moves through the body) and pharmacodynamics (understanding the effects of a drug on certain target sites of activity in the body).
- Conditions
- Healthy Volunteers
- Being tested
- PF-04308515, Placebo
- Keywords
- Safety; tolerability; pharmacokinetics/pharmacodynamics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-04308515Drug
Oral solution/suspension 0.1 mg up to potentially 350 mg QD at a single dose.
PlaceboDrug
Placebo solution/suspension to match active drug QD at a single dose.
| Study group | Role | What they receive |
|---|---|---|
| PF-04308515 | Experimental | Not described Receives: Drug: PF-04308515 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety, tolerability and pharmacokinetics (PK) of single-rising doses of PF-04308515
Measured: 1 day
To characterize the pharmacodynamic (PD) effects of PF-04308515 on biomarkers
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2009 (estimated)
- Study startOct 2009
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- 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
- NCT00990015
- Sponsor's protocol ID
- B0861001
- Status last verified
- Jan 2010
- First submitted
- 2 Oct 2009
- Last updated
- 1 Feb 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-Blind, Sponsor-Open, Placebo-Controlled, Single-Dose Escalation Trial Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PF-04308515 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00990015
- Acronym / sponsor ID
- B0861001
- Conditions
- Healthy Volunteers
- Keywords
- Safety; tolerability; pharmacokinetics/pharmacodynamics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 6 Oct 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.
The purpose of this study is to determine the safety, tolerability, pharmacokinetics (understanding how a drug is absorbed and moves through the body) and pharmacodynamics (understanding the effects of a drug on certain target sites of activity in the body).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PF-04308515 | Experimental | Drug: PF-04308515 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy males between 18 and 55 years, inclusive
- Healthy females between 18 and 44 years, inclusive.
- Women need to be surgically sterile
Key exclusion criteria (3 listed)
- Evidence or history of clinically significant disease
- Post-menopausal women
- History of intolerance or significant adverse effects with glucocorticoids
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-04308515Oral solution/suspension 0.1 mg up to potentially 350 mg QD at a single dose. | Drug | PF-04308515 |
| PlaceboPlacebo solution/suspension to match active drug QD at a single dose. | Drug | Placebo |
Primary outcome
To evaluate the safety, tolerability and pharmacokinetics (PK) of single-rising doses of PF-04308515
Time frame: 1 day
To characterize the pharmacodynamic (PD) effects of PF-04308515 on biomarkers
Time frame: 1 day
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 1 Feb 2010.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Screening Protocol
Pain
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-04308515 in people with Healthy Volunteers, 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 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 1 Feb 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?
To evaluate the safety, tolerability and pharmacokinetics (PK) of single-rising doses of PF-04308515 (time frame: 1 day). 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 1 Feb 2010.