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Human VolunteersPhase 1NCT01468714

A Study To Estimate The Effect Of Ketoconazole On The Pharmacokinetics Of Pf-04937319 In Healthy Subjects

A Phase 1 study testing PF-04937319 / ketoconazole in people with Human Volunteers, run by Pfizer at 1 site in United States.

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 will evaluate the potential for a drug-drug interaction of PF-04937319 with ketoconazole, a potent inhibitor of the drug metabolizing enzyme CYP3A. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Human Volunteers
What is being tested?
PF-04937319 / ketoconazole
How many people
10 participants
Where
1 siteUnited States
Study dates
Oct 2011to Oct 2011
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 and/or female subjects 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 measurement, 12-lead ECG or clinical laboratory tests.
  • Body Mass Index (BMI) of 17.5 to 29.9 kg/m2; and a total body weight >=50 kg (110 lbs).
  • 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.

Who cannot join

  • Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication.
  • Pregnant or nursing females; females of childbearing potential who are unwilling or unable to use an acceptable method of non-hormonal contraception
  • Consumption of grapefruit-containing products within 7 days prior to the first dose of study medication and while in the study protocol from at least 14 days prior to the first dose of study medication and for at least 28 days after the last dose of study medication

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Pfizer Investigational Site

    New Haven, Connecticut, 06511

Other trials in United States

About this study

Official title: A Phase I, Open-Label, Fixed Sequence Study To Estimate The Steady-State Effect Of Ketoconazole On The Single-Dose Pharmacokinetics Of PF-04937319 In Healthy Adult Subjects

This study will evaluate the potential for a drug-drug interaction of PF-04937319 with ketoconazole, a potent inhibitor of the drug metabolizing enzyme CYP3A.

Being tested
PF-04937319 / ketoconazole
Keywords
Drug Interaction, pharmacokinetics, ketoconazole, CYP3A

What participants receive

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

  • PF-04937319 / ketoconazoleDrug

    Single 20 mg dose of PF-04937319 on day 1, multiple dose of ketoconazole 200 mg twice daily from day 3 to 7, single 20 mg dose of PF-04937319 on day 6

What is being measured

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

  1. Cmax of PF-04937319

    Measured: Day 1 & Day 6

  2. Tmax of PF-04937319

    Measured: Day 1 & Day 6

  3. AUClast of PF-04937319

    Measured: Day 1 & Day 6

  4. (as data permits) AUCinf of PF-04937319

    Measured: Day 1 & Day 6

  5. (as data permits) t1/2 of PF-04937319

    Measured: Day 1 & Day 6

  6. Cmax of PF-04937319 M1 metabolite

    Measured: Day 1 & Day 6

  7. Tmax of PF-04937319 M1 metabolite

    Measured: Day 1 & Day 6

  8. AUClast of PF-04937319 M1 metabolite

    Measured: Day 1 & Day 6

  9. (as data permits) AUCinf of PF-04937319 M1 metabolite

    Measured: Day 1 & Day 6

  10. (as data permits) t1/2 of PF-04937319 M1 metabolite

    Measured: Day 1 & Day 6

Secondary outcomes (2)

  1. Urinary recovery of PF-04937319 M1 metabolite

    Measured: Day 1

  2. (as data permits) renal clearance (CLr) of PF-04937319 M1 metabolite

    Measured: Day 1

Timeline

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

  1. First posted9 Nov 2011 (estimated)
  2. Study startOct 2011
  3. Primary completionOct 2011
  4. Study completionOct 2011

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
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01468714
Sponsor's protocol ID
B1621011
Status last verified
Nov 2011
First submitted
4 Oct 2011
Last updated
16 Nov 2011
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing PF-04937319 / ketoconazole in people with Human 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 16 Nov 2011. 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?

Cmax of PF-04937319 (time frame: Day 1 & Day 6). 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 NCT01468714.

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 16 Nov 2011; AzTrials last refreshed its copy on 6 Nov 2026.

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