CompletedNCT01247883Updated Feb 2, 2011

A Comparison Of A Single PF-04634817 Tablet Dose Compared With A Solution In Healthy Volunteers

A Phase 1 interventional study of PF-04634817 and PF-04634817 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 2011-02-02.

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

Phase: Phase 1
Study type: Interventional
Enrollment: 13
Allocation: Randomized
Ages: 18 Years to 55 Years
Sex: All

Study summary

This study investigates the safety, tolerability and pharmacokinetics of PF-04634817 when respectively given orally as a single tablet dose and a single dose of a solution.

Conditions studied

Healthy

Keywords

Phase 1
relative bioavailability
healthy volunteers
pharmacokinetics
solution
tablet

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.

Who can participate

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

Inclusion criteria

Healthy male and/or female subjects (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history and full physical examination.)
Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).

Exclusion criteria

Exclusion Criteria:

Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease;
Treatment with an investigational drug within 30 days or 5 half-lives (whichever is longer) preceding the first dose of study medication;
Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day;
Nursing females;
Females of childbearing potential.

Study design

Phase: Phase 1
Primary purpose: Basic science
Allocation: Randomized
Intervention model: Crossover assignment
Masking: None (open label)
Enrollment: 13 participants (actual)

Study arms

Active comparator
single dose PF-04634817 tablet
subjects receive a single dose of PF-04634817 as a tablet
Drug: PF-04634817
Active comparator
single dose PF-04634817 solution
subjects receive a single dose of PF-04634817 as a solution
Drug: PF-04634817

Interventions

DrugPF-04634817
single dose, 20mg, tablet
DrugPF-04634817
single dose, 20mg, solution

What researchers measure

Primary outcomes

adverse events
Time frame: 4 days
Plasma Pharmacokinetics for both tablet and solution dosage forms.
Time frame: 4 days
The relative bioavailability (Frel) of PF-04634817 when administered as a tablet compared with a solution.
Time frame: 4 days
lab measurements
Time frame: 4 days
vitals/ECG parameters
Time frame: 4 days

Study locations

1 site

Pfizer Investigational Site
New Haven, Connecticut 06511, United States

References and documents

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Feb 2, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01247883
Lead sponsor: Pfizer
Collaborators: Incyte Corporation
First posted: Nov 24, 2010
Start date: Oct 2010
Primary completion: Dec 2010
Completion: Dec 2010
Last update: Feb 2, 2011

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 Jan 2011. 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.

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.

Other studies from this sponsor

Pfizer

Start the discussion