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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2014-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study Of The Safety, Tolerability, And Pharmacokinetics Of Multiple Doses Of PF-05180999 In Healthy Adults

NCT01981486

Migraine

WITHDRAWN PHASE1

A Study to Assess the Relative Bioavailability of a Modified-Release Formulation of PF-05180999

NCT01530529

Healthy

COMPLETED PHASE1

A Single Dose Study Of PF-06291874 In Healthy Adult Subjects

NCT01499017

Healthy

TERMINATED PHASE1

A Study To Observe Safety And Blood Concentrations Of PF-06649751 During And Following The Oral Administration Of Multiple Doses Of PF-06649751 In Healthy Adult Western and Japanese Volunteers

NCT02066909

Healthy

COMPLETED PHASE1

A Study In Healthy People To Evaluate Safety, Toleration And Time Course Of Plasma Concentration Of Multiple Oral Doses Of PF-04895162

NCT01691274

Healthy

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Migraine

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Arm A1

Part A of study to assess safety, tolerability, and pharmacokinetics of PF-05180999

Group Type EXPERIMENTAL

PF-05180999

Intervention Type DRUG

Ascending single oral doses of 120, 240, and 420 mg modified-release tablets

Arm A2

Part A of study to assess safety, tolerability, and pharmacokinetics of PF-05180999 relative to placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo tablets

Arm B1

Part B of study to assess effects of PF-05180999 on histamine-induced wheal

Group Type EXPERIMENTAL

120 mg MR PF-05180999

Intervention Type DRUG

Single 120 mg dose administered as modified release formulation

Arm B2

Part B of study to assess effects of PF-05180999 on histamine-induced wheal

Group Type EXPERIMENTAL

360 mg MR PF-05180999

Intervention Type DRUG

Single 360 mg dose administered as modified release formulation

Arm B3

Positive control to ensure histamine-induced wheal assay integrity

Group Type EXPERIMENTAL

10 mg cetirizine

Intervention Type DRUG

Single 10 mg dose of cetirizine

Arm B4

Placebo control

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

Placebo tablets

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

PF-05180999

Ascending single oral doses of 120, 240, and 420 mg modified-release tablets

Intervention Type DRUG

Placebo

Placebo tablets

Intervention Type DRUG

120 mg MR PF-05180999

Single 120 mg dose administered as modified release formulation

Intervention Type DRUG

360 mg MR PF-05180999

Single 360 mg dose administered as modified release formulation

Intervention Type DRUG

10 mg cetirizine

Single 10 mg dose of cetirizine

Intervention Type DRUG

Placebo

Placebo tablets

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes