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A Phase 1 Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Pf-05230907 In Healthy Volunteers

NCT ID: NCT01897142

Last Updated: 2016-04-22

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

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2015-03-31

Brief Summary

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The purpose of this study is to determine what the study drug does to the body, what the body does to the study drug, and if the study drug is safe and well tolerated when given to adult healthy volunteers.

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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

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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PF-05230907 and Placebo Cohort 1

Group Type EXPERIMENTAL

PF-05230907

Intervention Type BIOLOGICAL

0.1 micrograms per kilogram of PF-05230907, IV bolus, single dose

Placebo for PF-05230907

Intervention Type DRUG

0.1 micrograms per kilogram of placebo for PF-05230907, IV bolus, single dose

PF-05230907 and Placebo Cohort 2

Group Type EXPERIMENTAL

PF-05230907

Intervention Type BIOLOGICAL

0.3 micrograms per kilogram of PF-05230907, IV bolus, single dose

Placebo for PF-05230907

Intervention Type DRUG

0.3 micrograms per kilogram of placebo for PF-05230907, IV bolus, single dose

PF-05230907 and Placebo Cohort 3

Group Type EXPERIMENTAL

PF-05230907

Intervention Type BIOLOGICAL

1 micrograms per kilogram of PF-05230907, IV bolus, single dose

Placebo for PF-05230907

Intervention Type DRUG

1 micrograms per kilogram of placebo for PF-05230907, IV bolus, single dose

PF-05230907 and Placebo Cohort 4

Group Type EXPERIMENTAL

PF-05230907

Intervention Type BIOLOGICAL

2 micrograms per kilogram of PF-05230907, IV bolus, single dose

Placebo for PF-05230907

Intervention Type DRUG

2 micrograms per kilogram of placebo for PF-05230907, IV bolus, single dose

PF-05230907 and Placebo Cohort 5

Group Type EXPERIMENTAL

PF-05230907

Intervention Type BIOLOGICAL

3 micrograms per kilogram of PF-05230907, IV bolus, single dose

Placebo for PF-05230907

Intervention Type DRUG

3 micrograms per kilogram of placebo for PF-05230907, IV bolus, single dose

PF-05230907 and Placebo Cohort 6

Group Type EXPERIMENTAL

PF-05230907

Intervention Type BIOLOGICAL

5 micrograms per kilogram of PF-05230907, IV bolus, single dose

Placebo for PF-05230907

Intervention Type DRUG

5 micrograms per kilogram of placebo for PF-05230907, IV bolus, single dose

Interventions

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PF-05230907

0.1 micrograms per kilogram of PF-05230907, IV bolus, single dose

Intervention Type BIOLOGICAL

Placebo for PF-05230907

0.1 micrograms per kilogram of placebo for PF-05230907, IV bolus, single dose

Intervention Type DRUG

PF-05230907

0.3 micrograms per kilogram of PF-05230907, IV bolus, single dose

Intervention Type BIOLOGICAL

Placebo for PF-05230907

0.3 micrograms per kilogram of placebo for PF-05230907, IV bolus, single dose

Intervention Type DRUG

PF-05230907

1 micrograms per kilogram of PF-05230907, IV bolus, single dose

Intervention Type BIOLOGICAL

Placebo for PF-05230907

1 micrograms per kilogram of placebo for PF-05230907, IV bolus, single dose

Intervention Type DRUG

PF-05230907

2 micrograms per kilogram of PF-05230907, IV bolus, single dose

Intervention Type BIOLOGICAL

Placebo for PF-05230907

2 micrograms per kilogram of placebo for PF-05230907, IV bolus, single dose

Intervention Type DRUG

PF-05230907

3 micrograms per kilogram of PF-05230907, IV bolus, single dose

Intervention Type BIOLOGICAL

Placebo for PF-05230907

3 micrograms per kilogram of placebo for PF-05230907, IV bolus, single dose

Intervention Type DRUG

PF-05230907

5 micrograms per kilogram of PF-05230907, IV bolus, single dose

Intervention Type BIOLOGICAL

Placebo for PF-05230907

5 micrograms per kilogram of placebo for PF-05230907, IV bolus, single dose

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy male subjects.
* Healthy non-child bearing female subjects.
* 18 to 35 years of age.

Exclusion Criteria

* Heart disease.
* Clotting disorders.
* Use of nicotine products.
* Diabetes.
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 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

Locations

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Pfizer Clinical Research Unit

Brussels, , Belgium

Site Status

Countries

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Belgium

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B2341001&StudyName=A%20Phase%201%20Study%20To%20Evaluate%20The%20Safety%2C%20Tolerability%2C%20Pharmacokinetics%20And%20Pharmacodynamics%20Of%20Pf-05230907%20In%20Healthy%20Volunteers

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

Other Identifiers

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2013-001387-36

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

B2341001

Identifier Type: -

Identifier Source: org_study_id

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