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NCT01924650 Clinical Trial

A Pharmacokinetic Study of Three Different Particle Sizes of PH-797804

Healthy Clinical Trial

Official title:
A Randomized, Open Label, Single Dose, 6 Treatment, 4-way Crossover Study in Healthy Subjects to Assess the Pharmacokinetics of Three Different Particle Sizes of PH-797804 Tablet With and Without the Solubilizing Agent Sodium Lauryl Sulphate (SLS)

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT01924650
Other study ID # A6631040
Secondary ID
Status Withdrawn
Phase Phase 1
First received August 14, 2013
Last updated December 19, 2013
Start date March 2014
Est. completion date June 2014

Study information
Verified date December 2013
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The purpose of this study is to investigate the effects of varying particle size on the pharmacokinetics of PH-797804

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date June 2014
Est. primary completion date June 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria:

- Healthy male subjects and/or healthy female subjects of non-child bearing 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 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 14 drinks/week for males.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

Intervention

Drug:
• PH-797804
Tablet, 6 mg, single dose
• PH-797804
Tablet, 6 mg, single dose
• PH-797804
Tablet, 6 mg, single dose
• PH-797804
Tablet, 6 mg, single dose
• PH-797804
Tablet, 6 mg, single dose
• PH-797804
Tablet, 6 mg, single dose

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Outcome
Type Measure Description Time frame Safety issue
Primary Area Under the Curve From Time Zero to Time 72 hours (AUC72) Area under the plasma concentration time-curve from zero to 72 hours (AUC72) 0,2,3,4,5,6,8,12,24,48,72 hours post-dose No
Primary Maximum Observed Plasma Concentration (Cmax) 0,2,3,4,5,6,8,12,24,48,72 hours post-dose No
Primary Time to Reach Maximum Observed Plasma Concentration (Tmax) 0,2,3,4,5,6,8,12,24,48,72 hours post-dose No
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