To Evaluate Safety, Tolerability, Plasma Drug Levels And Other Biological Effects In Healthy Volunteers

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

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2010-06-30

Brief Summary

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The purpose of this study is to evaluate safety and tolerability after a single administration of PF-03382792 in healthy volunteers.; and to evaluate plasma drug levels and biological activity.

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Detailed Description

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Evaluate the safety, tolerability, plasma concentrations of PF-03382792 and other biological activity following a single dose of PF-03382792. Three ascending single doses of PF-03382792 were administered in this study (0.05 mg, 0.15mg and 0.5 mg). The decision to terminate the study was made on June 4, 2010 due to safety findings and limitations regarding the levels of the metabolite projected for doses above 0.5 mg.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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PART A: Ascending Cohorts

Single ascending dose cross-over. (0.05, 0.15, 0.5, 1.5, 5, 15 mg)

Group Type EXPERIMENTAL

PF-03382792 Cohort 1

Intervention Type DRUG

First cohort for: Single oral ascending dose of PF-03382792, formulated in solution.

PF-03382792 Cohort 2

Intervention Type DRUG

Second cohort for: Single oral ascending dose of PF-03382792, formulated in solution.

PF-03382792

Intervention Type DRUG

Optional cohort 3: Single oral ascending dose of PF-03382792, formulated in solution.

PART B: Food effect

Food effect on PF-03382792 PK

Group Type EXPERIMENTAL

Food Effect cohort

Intervention Type DRUG

Single oral dose, cross-over to determine effect of food on PF-03382792 pharmacokinetics. Dose will be decided after reviewing data from the ascending dose portion.

PART C: CSF Cohort

Optional CSF Cohort

Group Type EXPERIMENTAL

CSF cohort

Intervention Type DRUG

Single oral dose of PF-03382792 formulated in solution. Dose will be decided after reviewing data from the ascending dose portion.

Interventions

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PF-03382792 Cohort 1

First cohort for: Single oral ascending dose of PF-03382792, formulated in solution.

Intervention Type DRUG

PF-03382792 Cohort 2

Second cohort for: Single oral ascending dose of PF-03382792, formulated in solution.

Intervention Type DRUG

PF-03382792

Optional cohort 3: Single oral ascending dose of PF-03382792, formulated in solution.

Intervention Type DRUG

Food Effect cohort

Single oral dose, cross-over to determine effect of food on PF-03382792 pharmacokinetics. Dose will be decided after reviewing data from the ascending dose portion.

Intervention Type DRUG

CSF cohort

Single oral dose of PF-03382792 formulated in solution. Dose will be decided after reviewing data from the ascending dose portion.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* For all cohorts, healthy male and/or female subjects of nonchildbearing potential between the ages of 18 and 55 years, inclusive.

Exclusion Criteria

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.
* History of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for males (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of Screening.
* Signs or symptoms of adrenal insufficiency.
* Ocular lens (eye) abnormalities.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes