HealthyPhase 1NCT01199900
Single Dose Study Of PF-04171327 And Prednisone On Carbohydrate Metabolism
A Phase 1 study testing PF-04171327 and Prednisone in people with Healthy, run by Pfizer at 1 site in United States.
Trial summary
This study will investigate the effect of a single dose of PF-04171327 or prednisone on calculated measures of glucose tolerance and insulin resistance by using a modified oral glucose tolerance test Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- PF-04171327 and Prednisone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI 17.5 to 30.5 kg/m2 and total body weight >50 kg
Who cannot join
- Fasting glucose above the limits of the reference range for healthy individuals
- "No treatment" Oral Glucose Tolerance Test (OGTT) indicative of impaired fasting glucose or impaired glucose tolerance
- Severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation
Trial locations and contacts
1 site in 1 country.
United States1 site
Pfizer Investigational Site
Kalamazoo, Michigan, 49007
About this study
Official title: An Open Label Study Evaluating The Effect Of Single Doses Of PF-04171327 And Prednisone On Carbohydrate Metabolism Utilizing An Oral Glucose Tolerance Test In Healthy Adult Subjects
This study will investigate the effect of a single dose of PF-04171327 or prednisone on calculated measures of glucose tolerance and insulin resistance by using a modified oral glucose tolerance test
- Conditions
- Healthy
- Being tested
- PF-04171327, Prednisone
- Keywords
- Healthy People, Glucocorticoids, Prednisone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-04171327Drug
25 mg extemporaneous preparation of oral solution predosed 8 hours prior to Oral Glucose Tolerance Test (OGTT)
PF-04171327Drug
25 mg extemporaneous preparation of oral solution predosed 12 hours prior to Oral Glucose Tolerance Test (OGTT)
PrednisoneDrug
5 mg tablet predosed at 8 hours prior to Oral Glucose Tolerance Test (OGTT)
PF-04171327Drug
3 mg extemporaneous preparation of oral solution predosed at time selected from Part 1 prior to Oral Glucose Tolerance Test (OGTT)
PF-04171327Drug
10 mg extemporaneous preparation of oral solution predosed at time selected from Part 1 prior to Oral Glucose Tolerance Test (OGTT)
PrednisoneDrug
5 mg tablet predosed at 8 hours prior to Oral Glucose Tolerance Test (OGTT)
PrednisoneDrug
5 mg tablets predosed at 8 hours prior to Oral Glucose Tolerance Test (OGTT)
| Study group | Role | What they receive |
|---|---|---|
| (Part 1) 25 mg PF-04171327 predosed at -8 hours prior to OGTT | Experimental | Not described Receives: Drug: PF-04171327 |
| (Part 1) 25 mg PF-04171327 predosed at -12 hours prior to OGTT | Experimental | Not described Receives: Drug: PF-04171327 |
| (Part 1) 5 mg Prednisone | Active comparator | 5 mg prednisone tablet predosed at 8 hours prior to Oral Glucose Tolerance Test (OGTT) Receives: Drug: Prednisone |
| (Part 2) 3 mg PF-04171327 | Experimental | Not described Receives: Drug: PF-04171327 |
| (Part 2) 10 mg PF-04171327 | Experimental | Not described Receives: Drug: PF-04171327 |
| (Part 2) 5 mg Prednisone | Active comparator | Not described Receives: Drug: Prednisone |
| (Part 2) 20 mg Prednisone | Active comparator | Not described Receives: Drug: Prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fold change in AUC (0-4h) relative to no treatment baseline for plasma glucose, plasma insulin, and plasma C-peptide
Measured: 4 hours
Secondary outcomes (3)
Pharmacodynamic effects on plasma glucose, plasma insulin, and plasma c-peptide
Measured: 3 days
Safety: adverse events, vital sign measurements, physical examination
Measured: 3 days
Pharmacokinetics: sparse plasma samples will be collected for characterization of PF-0251802 pharmacokinetics (PK)
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2010 (estimated)
- Study startAug 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
- None (open label)
- Enrolment
- 18 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
- NCT01199900
- Sponsor's protocol ID
- A9391006
- Status last verified
- Dec 2010
- First submitted
- 9 Sep 2010
- Last updated
- 17 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Study Evaluating The Effect Of Single Doses Of PF-04171327 And Prednisone On Carbohydrate Metabolism Utilizing An Oral Glucose Tolerance Test In Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT01199900
- Acronym / sponsor ID
- A9391006
- Conditions
- Healthy
- Keywords
- Healthy People, Glucocorticoids, Prednisone
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Aug 2010
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 13 Sep 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.
This study will investigate the effect of a single dose of PF-04171327 or prednisone on calculated measures of glucose tolerance and insulin resistance by using a modified oral glucose tolerance test
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| (Part 1) 25 mg PF-04171327 predosed at -8 hours prior to OGTT | Experimental | Drug: PF-04171327 |
| (Part 1) 25 mg PF-04171327 predosed at -12 hours prior to OGTT | Experimental | Drug: PF-04171327 |
| (Part 1) 5 mg Prednisone | Active comparator | Drug: Prednisone5 mg prednisone tablet predosed at 8 hours prior to Oral Glucose Tolerance Test (OGTT) |
| (Part 2) 3 mg PF-04171327 | Experimental | Drug: PF-04171327 |
| (Part 2) 10 mg PF-04171327 | Experimental | Drug: PF-04171327 |
| (Part 2) 5 mg Prednisone | Active comparator | Drug: Prednisone |
| (Part 2) 20 mg Prednisone | Active comparator | Drug: Prednisone |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- BMI 17.5 to 30.5 kg/m2 and total body weight >50 kg
Key exclusion criteria (3 listed)
- Fasting glucose above the limits of the reference range for healthy individuals
- "No treatment" Oral Glucose Tolerance Test (OGTT) indicative of impaired fasting glucose or impaired glucose tolerance
- Severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation
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-0417132725 mg extemporaneous preparation of oral solution predosed 8 hours prior to Oral Glucose Tolerance Test (OGTT) | Drug | (Part 1) 25 mg PF-04171327 predosed at -8 hours prior to OGTT |
| PF-0417132725 mg extemporaneous preparation of oral solution predosed 12 hours prior to Oral Glucose Tolerance Test (OGTT) | Drug | (Part 1) 25 mg PF-04171327 predosed at -12 hours prior to OGTT |
| Prednisone5 mg tablet predosed at 8 hours prior to Oral Glucose Tolerance Test (OGTT) | Drug | (Part 1) 5 mg Prednisone |
| PF-041713273 mg extemporaneous preparation of oral solution predosed at time selected from Part 1 prior to Oral Glucose Tolerance Test (OGTT) | Drug | (Part 2) 3 mg PF-04171327 |
| PF-0417132710 mg extemporaneous preparation of oral solution predosed at time selected from Part 1 prior to Oral Glucose Tolerance Test (OGTT) | Drug | (Part 2) 10 mg PF-04171327 |
| Prednisone5 mg tablet predosed at 8 hours prior to Oral Glucose Tolerance Test (OGTT) | Drug | (Part 2) 5 mg Prednisone |
| Prednisone5 mg tablets predosed at 8 hours prior to Oral Glucose Tolerance Test (OGTT) | Drug | (Part 2) 20 mg Prednisone |
Primary outcome
Fold change in AUC (0-4h) relative to no treatment baseline for plasma glucose, plasma insulin, and plasma C-peptide
Time frame: 4 hours
3 secondary outcomes
Pharmacodynamic effects on plasma glucose, plasma insulin, and plasma c-peptide
Time frame: 3 days
Safety: adverse events, vital sign measurements, physical examination
Time frame: 3 days
Pharmacokinetics: sparse plasma samples will be collected for characterization of PF-0251802 pharmacokinetics (PK)
Time frame: 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 17 Dec 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-04171327 and Prednisone 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 1 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 17 Dec 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. 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?
Fold change in AUC (0-4h) relative to no treatment baseline for plasma glucose, plasma insulin, and plasma C-peptide (time frame: 4 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 17 Dec 2010.