CClinicalTrials.gg
CompletedNCT01747941Updated May 23, 2013

Study to Investigate the Safety, Tolerability, Pharmacokinetics of PF-06305591 in Healthy Male and Female Subjects

A Phase 1 interventional study of PF-06305591 and Placebo in Healthy, sponsored by Pfizer. Completed at 1 site in Belgium. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-05-23.

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

Phase
Phase 1
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

The study is designed to test safety tolerability and PK of single oral ascending doses of PF-06305591,

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

Inclusion criteria

  • healthy young subjects
  • aged 18-55

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).
  • Pregnant or nursing females; females of childbearing potential.
05

Study design

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

Study arms

  • Experimental
    Cohort 1

    Single ascending oral doses in fasted conditions

    Drug: PF-06305591 · Drug: Placebo

  • Experimental
    Cohort 2

    Single ascending oral doses in fasted conditions

    Drug: PF-06305591 · Drug: Placebo

  • Experimental
    Cohort 3

    Single ascending oral doses in fed conditions

    Drug: PF-06305591 · Drug: Placebo

Interventions

  • DrugPF-06305591

    single dose, solution

  • DrugPlacebo

    matching placebo

  • DrugPF-06305591

    single dose, solution

  • DrugPlacebo

    matching placebo

  • DrugPF-06305591

    single dose, solution

  • DrugPlacebo

    matching placebo

06

What researchers measure

Primary outcomes

  1. Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Time frame: 72 hr

Secondary outcomes

  1. Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]

    Time frame: 72 hr

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 May 23, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01747941
Lead sponsor
Pfizer
Responsible party
Sponsor
First posted
Dec 12, 2012
Start date
Nov 2012
Primary completion
May 2013
Completion
May 2013
Last update
May 23, 2013

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 May 2013. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion