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CompletedNCT01637285Updated Jul 31, 2015

A Pharmacokinetic Study of CVX-096 (PF-04856883) in Healthy Volunteers

A Phase 1 interventional study of PF-04856883 and PF-04856883 in Healthy, sponsored by Pfizer. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-07-31.

Sponsored by Pfizer · Phase 1 and Interventional

Phase
Phase 1
Study type
Interventional
Enrollment
49
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

The purpose of the study is to further evaluate the PK characteristics of PF-04856883.

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.

Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

Inclusion Criteria:

-

Exclusion Criteria:

-

05

Study design

Phase
Phase 1
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
49 participants (actual)

Study arms

  • Experimental
    PF-04856883 Treatment Arm 1

    Biological: PF-04856883

  • Experimental
    PF-04856883 Treatment Arm 2

    Biological: PF-04856883

  • Experimental
    PF-04856883 Treatment Arm 3

    Biological: PF-04856883

  • Experimental
    PF-04856883 Treatment Arm 4

    Biological: PF-04856883

Interventions

  • BiologicalPF-04856883

    Dose A

  • BiologicalPF-04856883

    Dose B

  • BiologicalPF-04856883

    Dose C

  • BiologicalPF-04856883

    Dose D

06

What researchers measure

Primary outcomes

  1. PF-04856883 Pharmacokinetics including Cmax, Tmax, AUCo-infinity, AUClast, Cl/F, Vz/F and t1/2

    Time frame: 4 weeks

Secondary outcomes

  1. Number of subjects with AEs reported

    Time frame: 4 weeks

  2. Number of subjects with abnormal physical examination findings

    Time frame: 4 weeks

  3. Number of subjects with abnormal clinical laboratory results

    Time frame: 4 weeks

  4. Number of subjects with abnormal ECGs

    Time frame: 4 weeks

  5. Number of subjects with abnormal vital signs

    Time frame: 4 weeks

07

Study locations

1 site
  • New Haven Clinical Research Unit
    New Haven, Connecticut 06511, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 31, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01637285
Lead sponsor
Pfizer
Responsible party
Sponsor
First posted
Jul 11, 2012
Start date
Aug 2012
Primary completion
Jan 2013
Completion
Jan 2013
Last update
Jul 31, 2015

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.

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