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CompletedNCT01934738Updated Mar 11, 2014

A Study to Evaluate Safety, Toleration and Time Course of Plasma Concentration of Multiple Oral Doses of PF-06273340 in Healthy Subjects of Two AgeGroups, Aged 18-55 Years (Group 1) and Aged 56-75 Years (Group 2)

A Phase 1 interventional study of PF-06273340 and Placebo in Healthy, sponsored by Pfizer. Completed at 1 site in Belgium. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-03-11.

Sponsored by Pfizer · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
52
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

The purpose of this study is to investigate safety, toleration and time course of plasma concentration of multiple oral doses of PF-06273340 for 14 days in healthy subjects of two age groups, aged 18-55 years (Group 1) and aged 56-75 years (Group 2)

02

Conditions studied

  • Healthy

Keywords

  • Multiple dose
  • safety
  • tolerability
  • PK
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 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • For Group 1 specific: Healthy male and/or female subjects of non-childbearing potential 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 and clinical laboratory tests).
  • For Group 2 specific: Healthy male and/or female subjects of non-childbearing potential between the ages of 56 and 75 years, inclusive. Subjects must be in reasonably good health as determined by the investigator based on a detailed medical history, full physical examination (including blood pressure and pulse rate measurement), 12-lead ECG and clinical laboratory tests. Subjects with mild, chronic, stable disease (eg, osteoarthritis) may be enrolled if deemed medically prudent by the investigator. In order to ensure an age range relevant to the osteoarthritis (OA) population, at least 50% of the subjects enrolled in these cohorts must be 60 years of age and above at Screening.
  • For Group 2 specific: Subjects taking daily prescription or non-prescription medications for management of acceptable chronic medical conditions must be on a stable dose of these, as defined by non change in dose for the 3 months prior to the first dose of study medication and no planned changes during the conduct of the study.

Exclusion criteria

Exclusion Criteria:

  • 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 the time of dosing).
  • Any condition possibly affecting drug absorption (eg, gastrectomy).
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
52 participants (actual)

Study arms

  • Experimental
    Group 1: Cohort 1

    Drug: PF-06273340 · Drug: Placebo

  • Experimental
    Group 1: Cohort 2

    Drug: PF-06273340 · Drug: Placebo

  • Experimental
    Group 1: Cohort 3

    Drug: PF-06273340 · Drug: Placebo

  • Experimental
    Group 2: Cohort 4

    Drug: PF-06273340 · Drug: Placebo

  • Experimental
    Group 1: Cohort 5

    Drug: PF-06273340 · Drug: Placebo

  • Experimental
    Group 2: Cohort 6

    Drug: PF-06273340 · Drug: Placebo

Interventions

  • DrugPF-06273340

    Tablets, 100 mg TID, 14 days

  • DrugPlacebo

    Tablets, TID, 14 days

  • DrugPF-06273340

    Tablets, to be decided dose, TID or titration, 14 days

  • DrugPlacebo

    Tablets, TID or titration, 14 days

  • DrugPF-06273340

    Tablets, to be decided dose, TID or titration, 14 days

  • DrugPlacebo

    Tablets, TID or titration, 14 days

  • DrugPF-06273340

    Tablets, to be decided dose, TID or titration, 14 days

  • DrugPlacebo

    Tablets, TID or titration, 14 days

  • DrugPF-06273340

    Tablets, to be decided dose, TID or titration, 14 days

  • DrugPlacebo

    Tablets, TID or titration, 14 days

  • DrugPF-06273340

    Tablets, to be decided dose, TID or titration, 14 days

  • DrugPlacebo

    Tablets, TID or titration, 14 days

06

What researchers measure

Primary outcomes

  1. Maximum Observed Plasma Concentration (Cmax)

    Time frame: 14 days

  2. Area Under the Curve from Time Zero to end of dosing interval (AUCtau)

    Time frame: 14 days

  3. Time to Reach Maximum Observed Plasma Concentration (Tmax)

    Time frame: 14 days

07

Study locations

1 site
  • Pfizer Investigational Site
    Brussels, B-1070, Belgium
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 11, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01934738
Lead sponsor
Pfizer
Responsible party
Sponsor
First posted
Sep 4, 2013
Start date
Oct 2013
Primary completion
Mar 2014
Completion
Mar 2014
Last update
Mar 11, 2014

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 Mar 2014. You cannot join it, but the record below documents what was studied.

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