A Study To Investigate The Effect Of Food On The Pharmacokinetics Of PH-797804

A Phase 1, Randomized, Open-Label, Single Dose, 2-Cohort Crossover Study To Determine The Effect Of Food On The Pharmacokinetics Of Orally Administered PH-797804 In Healthy Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01479647

Enrollment

Registered

2011-11-24

Start date

2011-12-31

Completion date

2012-02-29

Last updated

2012-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

Brief summary

The purpose of this study is to investigate the effect of food on the time course of PH-797804 concentration in the blood following dosing by oral immediate release tablet formulation.

Interventions

DRUGPH-797804

Tablet, 1 mg, single dose

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

21 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy male subjects and/or healthy female subjects of non-child bearing potential between the ages of 21 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 measurements, 12-lead ECG and clinical laboratory tests. * Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \> 50 kg (110 lbs).

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 time of dosing). * A positive urine drug screen. * History of regular alcohol consumption exceeding 21 drinks/week for males.

Design outcomes

Primary

Measure	Time frame
Pharmacokinetics: peak plasma concentration	0,1,2,3,4,6,8,12,24,48,72,96,144,192,264,312 hours post-dose
Pharmacokinetics: time to peak plasma concentration	0,1,2,3,4,6,8,12,24,48,72,96,144,192,264,312 hours post-dose
Pharmacokinetics: area under the plasma concentration-time curve	0,1,2,3,4,6,8,12,24,48,72,96,144,192,264,312 hours post-dose
Pharmacokinetics: terminal plasma half-life	0,1,2,3,4,6,8,12,24,48,72,96,144,192,264,312 hours post-dose

Countries

Singapore

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026