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HealthyPhase 1NCT01513928

A Study To Compare The Pharmacokinetics Of Different Formulations Of PF-04937319 In Healthy Subjects

A Phase 1 study testing Pf-04937319 in people with Healthy, run by Pfizer at 1 site in Singapore.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is designed to compare the pharmacokinetics of three different formulations of Pf-04937319 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?
Pf-04937319
Type of treatment
Pill or oral medicine
How many people
12 participants
Where
1 siteSingapore
Study dates
Jan 2012to Feb 2012
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, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG or clinical laboratory tests.
  • Subjects of childbearing potential must agree to use a highly effective method of contraception throughout the study and for at least 28-days after the last dose of treatment.
  • Body Mass Index (BMI) of 23 to 33 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 (excluding untreated seasonal allergies).
  • Any condition possibly affecting drug absorption (eg, gastrectomy).
  • A positive urine drug screen.

Trial locations and contacts

1 site in 1 country.

Singapore1 site

  • Pfizer Investigational Site

    Singapore, Singapore, 188770

Other trials in Singapore

About this study

Official title: A Phase 1, Cross-Over, Single-Dose, Open-Label Study To Estimate The Relative Bioavailability Of Three Different Formulations Of PF-04937319 In Overweight And Obese Otherwise Healthy Subjects

This study is designed to compare the pharmacokinetics of three different formulations of Pf-04937319

Conditions
Healthy
Being tested
Pf-04937319
Keywords
pharmacokinetics, relative bioavailability, formulation comparison

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pf-04937319Drug

    Formulation A) Pf-04937319 50 mg - administered as tablet

  • Pf-04937319Drug

    Formulation B) Pf-04937319 50 mg - administered as capsule

  • Pf-04937319Drug

    Formulation C) Pf-04937319 50 mg - administered as capsule

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pf-04937319: Maximum plasma concentration (Cmax)

    Measured: 0 - 96 hours post dose

  2. Pf-04937319: Time for Cmax (Tmax)

    Measured: 0 - 96 hours post dose

  3. Pf-04937319: Area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration (AUClast)

    Measured: 0 - 96 hours post dose

  4. Pf-04937319: Area under the plasma concentration-time profile from time zero extrapolated to infinite time (AUCinf)

    Measured: 0 - 96 hours post dose

  5. Pf-04937319: terminal half-life (T1/2)

    Measured: 0 - 96 hours post dose

  6. PF-06455349: Maximum Observed Plasma Concentration (Cmax)

    Measured: 0 - 96 hours post dose

  7. PF-06455349: Time to Reach Maximum Observed Plasma Concentration (Tmax)

    Measured: 0 - 96 hours post dose

  8. PF-06455349: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)

    Measured: 0 - 96 hours post dose

  9. PF-06455349: Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]

    Measured: 0 - 96 hours post dose

  10. PF-06455349: Plasma Decay Half-Life (t1/2)

    Measured: 0 - 96 hours post dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jan 2012 (estimated)
  2. Study startJan 2012
  3. Primary completionFeb 2012
  4. Study completionFeb 2012

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01513928
Sponsor's protocol ID
B1621005
Status last verified
Mar 2012
First submitted
17 Jan 2012
Last updated
12 Mar 2012
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Pf-04937319 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 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 12 Mar 2012. 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?

Pf-04937319: Maximum plasma concentration (Cmax) (time frame: 0 - 96 hours post dose). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01513928.

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 12 Mar 2012.

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