HealthyPhase 1NCT01924650
A Pharmacokinetic Study of Three Different Particle Sizes of PH-797804
A Phase 1 study testing PH-797804 in people with Healthy, run by Pfizer.
Trial summary
The purpose of this study is to investigate the effects of varying particle size on the pharmacokinetics of PH-797804 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?
- PH-797804
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Mar 2014to Jun 2014
- 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 subjects and/or healthy female subjects of non-child bearing potential between the ages of 18 and 55 years (inclusive). Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurements, 12-lead ECG and clinical laboratory tests.
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight > 50 kg (110 lbs).
Who cannot join
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
- A positive urine drug screen.
- History of regular alcohol consumption exceeding 14 drinks/week for males.
About this study
Official title: A Randomized, Open Label, Single Dose, 6 Treatment, 4-way Crossover Study in Healthy Subjects to Assess the Pharmacokinetics of Three Different Particle Sizes of PH-797804 Tablet With and Without the Solubilizing Agent Sodium Lauryl Sulphate (SLS)
The purpose of this study is to investigate the effects of varying particle size on the pharmacokinetics of PH-797804
- Conditions
- Healthy
- Being tested
- PH-797804
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PH-797804Drug
Tablet, 6 mg, single dose
PH-797804Drug
Tablet, 6 mg, single dose
PH-797804Drug
Tablet, 6 mg, single dose
PH-797804Drug
Tablet, 6 mg, single dose
PH-797804Drug
Tablet, 6 mg, single dose
PH-797804Drug
Tablet, 6 mg, single dose
| Study group | Role | What they receive |
|---|---|---|
| PH-797804 PARTICLE SIZE 9-11UM | Experimental | Not described Receives: Drug: PH-797804 |
| PH-797804 PARTICLE SIZE 9-11UM WITH SLS | Experimental | Not described Receives: Drug: PH-797804 |
| PH-797804 PARTICLE SIZE <= 20UM | Experimental | Not described Receives: Drug: PH-797804 |
| PH-797804 PARTICLE SIZE <= 20UM WITH SLS | Experimental | Not described Receives: Drug: PH-797804 |
| PH-797804 PARTICLE SIZE <= 5UM | Experimental | Not described Receives: Drug: PH-797804 |
| PH-797804 PARTICLE SIZE <= 5UM WITH SLS | Experimental | Not described Receives: Drug: PH-797804 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Curve From Time Zero to Time 72 hours (AUC72)
Area under the plasma concentration time-curve from zero to 72 hours (AUC72)
Measured: 0,2,3,4,5,6,8,12,24,48,72 hours post-dose
Maximum Observed Plasma Concentration (Cmax)
Measured: 0,2,3,4,5,6,8,12,24,48,72 hours post-dose
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Measured: 0,2,3,4,5,6,8,12,24,48,72 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2013 (estimated)
- Study startMar 2014
- Primary completionJun 2014 (estimated)
- Study completionJun 2014 (estimated)
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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01924650
- Sponsor's protocol ID
- A6631040
- Status last verified
- Dec 2013
- First submitted
- 14 Aug 2013
- Last updated
- 20 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open Label, Single Dose, 6 Treatment, 4-way Crossover Study in Healthy Subjects to Assess the Pharmacokinetics of Three Different Particle Sizes of PH-797804 Tablet With and Without the Solubilizing Agent Sodium Lauryl Sulphate (SLS)
- ClinicalTrials.gov ID
- NCT01924650
- Acronym / sponsor ID
- A6631040
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- Jun 2014 (estimated)
- Study completion
- Jun 2014 (estimated)
- First posted
- 16 Aug 2013 (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 investigate the effects of varying particle size on the pharmacokinetics of PH-797804
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| PH-797804 PARTICLE SIZE 9-11UM | Experimental | Drug: PH-797804 |
| PH-797804 PARTICLE SIZE 9-11UM WITH SLS | Experimental | Drug: PH-797804 |
| PH-797804 PARTICLE SIZE <= 20UM | Experimental | Drug: PH-797804 |
| PH-797804 PARTICLE SIZE <= 20UM WITH SLS | Experimental | Drug: PH-797804 |
| PH-797804 PARTICLE SIZE <= 5UM | Experimental | Drug: PH-797804 |
| PH-797804 PARTICLE SIZE <= 5UM WITH SLS | Experimental | Drug: PH-797804 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy male subjects and/or healthy female subjects of non-child bearing potential between the ages of 18 and 55 years (inclusive). Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurements, 12-lead ECG and clinical laboratory tests.
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight > 50 kg (110 lbs).
Key exclusion criteria (3 listed)
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
- A positive urine drug screen.
- History of regular alcohol consumption exceeding 14 drinks/week for males.
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 |
|---|---|---|
| PH-797804Tablet, 6 mg, single dose | Drug | PH-797804 PARTICLE SIZE 9-11UM |
| PH-797804Tablet, 6 mg, single dose | Drug | PH-797804 PARTICLE SIZE 9-11UM WITH SLS |
| PH-797804Tablet, 6 mg, single dose | Drug | PH-797804 PARTICLE SIZE <= 20UM |
| PH-797804Tablet, 6 mg, single dose | Drug | PH-797804 PARTICLE SIZE <= 20UM WITH SLS |
| PH-797804Tablet, 6 mg, single dose | Drug | PH-797804 PARTICLE SIZE <= 5UM |
| PH-797804Tablet, 6 mg, single dose | Drug | PH-797804 PARTICLE SIZE <= 5UM WITH SLS |
Primary outcome
Area Under the Curve From Time Zero to Time 72 hours (AUC72)
Time frame: 0,2,3,4,5,6,8,12,24,48,72 hours post-dose
Area under the plasma concentration time-curve from zero to 72 hours (AUC72)
Maximum Observed Plasma Concentration (Cmax)
Time frame: 0,2,3,4,5,6,8,12,24,48,72 hours post-dose
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time frame: 0,2,3,4,5,6,8,12,24,48,72 hours post-dose
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2013.
- 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
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PH-797804 in people with Healthy, run by Pfizer.
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: withdrawn, as of the sponsor's last update on 20 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Area Under the Curve From Time Zero to Time 72 hours (AUC72) (time frame: 0,2,3,4,5,6,8,12,24,48,72 hours post-dose). The study lists 3 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 20 Dec 2013.