A Study In Healthy Subjects Of Single Doses of PF-05230901 Injected Under The Skin

NCT ID: NCT01262690

Last Updated: 2011-10-12

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

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2011-09-30

Brief Summary

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This study will examine whether a single dose of PF-05230901 is safe and well tolerated when given to healthy volunteers by injection under the skin. An additional objective is to measure the blood concentrations of PF-05230901. Each dose will be tested in a different group of subjects starting from the lowest dose.

Detailed Description

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Conditions

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Cachexia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Dose

6 treated, 3 placebos

Group Type EXPERIMENTAL

PF-05230901

Intervention Type DRUG

Single ascending doses of PF-05230901 in separate cohorts of subjects; each cohort consists of 6 subjects treated with PF-05230901 and 3 subjects treated with placebo.

PF-05230901

Intervention Type DRUG

Single dose SC

Interventions

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PF-05230901

Single ascending doses of PF-05230901 in separate cohorts of subjects; each cohort consists of 6 subjects treated with PF-05230901 and 3 subjects treated with placebo.

Intervention Type DRUG

PF-05230901

Single dose SC

Intervention Type DRUG

Other Intervention Names

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TAM-153 TAM-163

Eligibility Criteria

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Inclusion Criteria

* Healthy subjects

Exclusion Criteria

* History of seizures, including childhood seizures.
* History of movement disorders or related neurological conditions.
* History of head trauma associated with loss of consciousness.
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

Locations

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Pfizer Investigational Site

New Haven, Connecticut, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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TAM-163 FIH Study; 3279K1-1000

Identifier Type: -

Identifier Source: secondary_id

B2291001

Identifier Type: -

Identifier Source: org_study_id