A Study To Assess The Safety, Tolerability And Pharmacokinetics Of PF-06282999 Administered Orally In Healthy Adult Subjects

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

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2013-03-31

Brief Summary

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This is the first-in-human study for an oral investigational compound, PF-06282999, in order to assess its safety, tolerability and pharmacokinetics in humans across a wide range of dose levels.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Cohort 1

Group Type EXPERIMENTAL

PF-06282999

Intervention Type DRUG

Solution, doses range from 20 to 200 mg, single dose

Placebo

Intervention Type DRUG

Solution, single dose

Cohort 2

Group Type EXPERIMENTAL

PF-06282999

Intervention Type DRUG

Methylcellulose suspension, doses range 125 to 500 mg, single dose

Placebo

Intervention Type DRUG

suspension, single dose

Cohort 3

Group Type EXPERIMENTAL

PF-06282999

Intervention Type DRUG

Methylcellulose or simethicone suspension, doses range 200 to 500 mg, single dose

Placebo

Intervention Type DRUG

suspension, single dose

Cohort 4

Group Type EXPERIMENTAL

PF-06282999

Intervention Type DRUG

Methylcellulose or simethicone suspension, 500 mg dose, single dose

Placebo

Intervention Type DRUG

suspension, single dose

Cohort 5

Group Type EXPERIMENTAL

PF-06282999

Intervention Type DRUG

Simethicone or methylcellulose suspension, up to 1500 mg, single dose

Placebo

Intervention Type DRUG

suspension, single dose

Interventions

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PF-06282999

Solution, doses range from 20 to 200 mg, single dose

Intervention Type DRUG

Placebo

Solution, single dose

Intervention Type DRUG

PF-06282999

Methylcellulose suspension, doses range 125 to 500 mg, single dose

Intervention Type DRUG

Placebo

suspension, single dose

Intervention Type DRUG

PF-06282999

Methylcellulose or simethicone suspension, doses range 200 to 500 mg, single dose

Intervention Type DRUG

Placebo

suspension, single dose

Intervention Type DRUG

PF-06282999

Methylcellulose or simethicone suspension, 500 mg dose, single dose

Intervention Type DRUG

Placebo

suspension, single dose

Intervention Type DRUG

PF-06282999

Simethicone or methylcellulose suspension, up to 1500 mg, single dose

Intervention Type DRUG

Placebo

suspension, single dose

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy male and/or female subjects 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 measurement, 12-lead ECG and clinical laboratory tests).
* Women must be of non-childbearing potential.
* 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 clinically significant drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
* Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication. Herbal supplements and hormone replacement therapy must be discontinued 28 days prior to the first dose of study medication. As an exception, acetaminophen/paracetamol may be used at doses of ≤1 g/day. Limited use of non-prescription medications that are not believed to affect subject safety or the overall results of the study may be permitted on a case-by-case basis following approval by the sponsor.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes