A Study of the Safety, Tolerability, Pharmacokinetics, And Effects On Histamine-Induced Wheal Of PF-05180999 In Healthy Adults

Migraine Clinical Trial

Official title:

A Phase 1, Placebo-Controlled, Crossover, Subject- And Investigator-Blind, Sponsor-Open Study To Evaluate The Safety, Tolerability, Pharmacokinetics, And Effects On Histamine-Induced Wheal Of A Modified-Release Formulation Of PF-05180999 In Healthy Adult Subjects

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01981499
• Other study ID #: B3441009
• Status: Terminated
• Phase: Phase 1
• First received: November 5, 2013
• Last updated: May 6, 2014
• Start date: January 2014
• Est. completion date: April 2014

Study information

• Verified date: May 2014
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

PF-05180999 is a phosphodiesterase-2 inhibitor that is hypothesized to be able to reduce vascular permeability. The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and effects on histamine-induced wheal of single doses of PF-05180999 in healthy adult subjects. Histamine-induced wheals are biomarkers of vascular permeability.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 31
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Healthy male subjects between the ages of 18 and 55 years

• No history of clinically-relevant atopic or dermatological disease

• Positive reaction to intradermal injection of histamine

Exclusion Criteria:

• Subjects with screening laboratory test results that deviate from the upper and/or lower limits of the reference or acceptable range. The exception is that all liver function tests must not exceed the upper limit of normal.

• Subjects with evidence of, or history of, hepatic disorder, including acute or chronic hepatitis B or hepatitis C

• Intolerance to intradermal histamine injection.

• Subjects with dark skin (Part B only).

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Migraine

Intervention

Drug:
• PF-05180999
Ascending single oral doses of 120, 240, and 420 mg modified-release tablets
• Placebo
Placebo tablets
• 120 mg MR PF-05180999
Single 120 mg dose administered as modified release formulation
• 360 mg MR PF-05180999
Single 360 mg dose administered as modified release formulation
• 10 mg cetirizine
Single 10 mg dose of cetirizine
• Placebo
Placebo tablets

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	St. Paul	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Observed Plasma Concentration (Cmax)	Maximum observed plasma concentration	0-72 hours post-dose	No
Primary	Time to Reach Maximum Observed Plasma Concentration (Tmax)	Time when Cmax occurred	0-72 hours post-dose	No
Primary	Area Under the Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUClast)	Measure of drug absorption and drug exposure	0-72 hours post-dose	No
Primary	Area Under the Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUCinf)	Measure of drug absorption and drug exposure	0-infinity hours post-dose	No
Primary	Plasma Half-Life (t1/2)	Time for the plasma concentration to decrease by one-half.	0-72 hours post-dose	No
Primary	Area Under the Effect Curve (AUEC) for Histamine-Induced Wheal	Measure of drug effect	2-12 hours post-dose	No
Secondary	Dose-response, exposure-response, and maximum response for PF-05180999 against histamine-induced wheal	Measures of drug effect	0-72 hours post-dose	No
Secondary	Area Under the Effect Curve (AUEC) for histamine-induced flare; Dose-response, exposure-response, and maximum response for PF-05180999 against histamine-induced flare	Measures of drug effect	0-72 hours post-dose	No

External Links

•   To obtain contact information for a study center near you, click here.