HealthyPhase 1NCT00928278
A Study Estimating The Time Course Of PF-04764793 In The Blood Following Dosing By Oral Inhalation From Dry Powder Inhalers
A Phase 1 study testing Treatment A, Treatment B and Treatment C in people with Healthy, run by Pfizer at 1 site in Singapore.
Trial summary
The purpose of this study is to investigate the time course of PF-04764793 concentration in the blood following dosing by oral inhalation from dry powder inhalers. Read more about this study
- Who is it for?
- Ages 21 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Treatment A, Treatment B and Treatment C
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteSingapore
- Study dates
- Jul 2009to Oct 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 21 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male and/or female subjects between the ages of 21 and 55 years.
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m^2; 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 females or 21 drinks/week for males.
- Pregnant or nursing females.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Study To Estimate The Plasma Pharmacokinetics Of PF-04764793 Administered Via Oral Inhalation Using Dry Powder Inhalers.
The purpose of this study is to investigate the time course of PF-04764793 concentration in the blood following dosing by oral inhalation from dry powder inhalers.
- Conditions
- Healthy
- Being tested
- Treatment A, Treatment B, Treatment C, Treatment D
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment ADrug
Inhaled, 300/150, single dose
Treatment BDrug
Inhaled, 300/150, single dose
Treatment CDrug
Inhaled, 300/150, single dose + oral activated charcoal block
Treatment DDrug
Inhaled, 300/150, single dose + oral activated charcoal block
| Study group | Role | What they receive |
|---|---|---|
| Treatment A - PF-04764793 | Experimental | PF-04764793 using inhaler A Receives: Drug: Treatment A |
| Treatment B - PF-04764793 | Active comparator | PF-04764793 using inhaler B Receives: Drug: Treatment B |
| Treatment C - PF-04764793 | Experimental | PF-04764793 using inhaler A Receives: Drug: Treatment C |
| Treatment D - PF-04764793 | Active comparator | PF-04764793 using inhaler B Receives: Drug: Treatment D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma pharmacokinetic parameters: AUClast and Cmax
Measured: 48 hours
Secondary outcomes (1)
Plasma pharmacokinetic parameters: AUC0-12, AUC0-24, AUCinf, Tmax and terminal half-life.
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2009 (estimated)
- Study startJul 2009
- Primary completionOct 2009
- Study completionOct 2009
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
- 36 participants (estimated)
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
- NCT00928278
- Sponsor's protocol ID
- B1691001
- Status last verified
- Dec 2009
- First submitted
- 24 Jun 2009
- Last updated
- 21 Dec 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Study To Estimate The Plasma Pharmacokinetics Of PF-04764793 Administered Via Oral Inhalation Using Dry Powder Inhalers.
- ClinicalTrials.gov ID
- NCT00928278
- Acronym / sponsor ID
- B1691001
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jul 2009
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 25 Jun 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 investigate the time course of PF-04764793 concentration in the blood following dosing by oral inhalation from dry powder inhalers.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Treatment A - PF-04764793 | Experimental | Drug: Treatment APF-04764793 using inhaler A |
| Treatment B - PF-04764793 | Active comparator | Drug: Treatment BPF-04764793 using inhaler B |
| Treatment C - PF-04764793 | Experimental | Drug: Treatment CPF-04764793 using inhaler A |
| Treatment D - PF-04764793 | Active comparator | Drug: Treatment DPF-04764793 using inhaler B |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy male and/or female subjects between the ages of 21 and 55 years.
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m^2; and a total body weight >50 kg (110 lbs).
Key exclusion criteria (4 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 females or 21 drinks/week for males.
- Pregnant or nursing 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 |
|---|---|---|
| Treatment AInhaled, 300/150, single dose | Drug | Treatment A - PF-04764793 |
| Treatment BInhaled, 300/150, single dose | Drug | Treatment B - PF-04764793 |
| Treatment CInhaled, 300/150, single dose + oral activated charcoal block | Drug | Treatment C - PF-04764793 |
| Treatment DInhaled, 300/150, single dose + oral activated charcoal block | Drug | Treatment D - PF-04764793 |
Primary outcome
Plasma pharmacokinetic parameters: AUClast and Cmax
Time frame: 48 hours
1 secondary outcome
Plasma pharmacokinetic parameters: AUC0-12, AUC0-24, AUCinf, Tmax and terminal half-life.
Time frame: 48 hours
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 21 Dec 2009.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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 Treatment A, Treatment B and Treatment C in people with Healthy, run by Pfizer at 1 site in Singapore.
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 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 21 Dec 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 Singapore. 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?
Plasma pharmacokinetic parameters: AUClast and Cmax (time frame: 48 hours). 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 21 Dec 2009.