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

NCT ID: NCT01981486

Last Updated: 2014-05-23

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

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2015-01-31

Brief Summary

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PF-05180999 is a novel phosphodiesterase-2 (PDE2) inhibitor. The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of multiple doses of PF-05180999 administered twice daily over 14 days. Exploratory measures of PDE2 inhibition will also be evaluated in blood and blister fluid.

Detailed Description

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Conditions

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Migraine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo

Placebo tablets

Group Type PLACEBO_COMPARATOR

Placebo Tablets

Intervention Type DRUG

BID modified-release tablets

PF-05180999

Modified-release tablets of PF-05180999

Group Type EXPERIMENTAL

PF-05180999 Tablets

Intervention Type DRUG

BID modified-release tablets (20 to 240 mg BID)

Interventions

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Placebo Tablets

BID modified-release tablets

Intervention Type DRUG

PF-05180999 Tablets

BID modified-release tablets (20 to 240 mg BID)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy male and/or female (of non-childbearing potential) subjects between the ages of 18 and 55 years
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs)

Exclusion Criteria

* Subjects with Gilbert's disease or 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.
* Subjects with very light skin or very dark skin (at the discretion of the investigator).
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Related Links

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Other Identifiers

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B3441008

Identifier Type: -

Identifier Source: org_study_id

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