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

Primary Purpose

Cachexia

Status

Terminated

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

PF-05230901

About this trial

This is an interventional treatment trial for Cachexia focused on measuring First-in-human (FIH), Single Ascending Dose (SAD) Study, TAM-163, PF-05230901, Cachexia

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Pfizer Investigational Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Dose

Arm Description

6 treated, 3 placebos

Outcomes

Primary Outcome Measures

Incidence and severity of adverse events.

Incidence and severity of clinical laboratory abnormalities.

Mean change from baseline in vital signs.

Mean change from baseline in 12-lead electrocardiogram (ECG) parameters.

Incidence and severity of findings during the neurological examination.

Secondary Outcome Measures

Plasma concentrations

Anti-drug antibodies

Appetite and food consumption

Full Information

NCT ID

NCT01262690

First Posted

November 23, 2010

Last Updated

October 11, 2011

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT01262690

Brief Title

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

Official Title

A Phase 1 Ascending Single Dose Study To Evaluate The Safety, Tolerability, And Pharmacokinetics Of PF-05230901 Administered Subcutaneously To Healthy Subjects

Study Type

Interventional

2. Study Status

Record Verification Date

October 2011

Overall Recruitment Status

Terminated

Why Stopped

The study was terminated on 21-Sept-2011 due to the emergent safety concern of sensory symptoms.

Study Start Date

November 2010 (undefined)

Primary Completion Date

September 2011 (Actual)

Study Completion Date

September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pfizer

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cachexia

Keywords

First-in-human (FIH), Single Ascending Dose (SAD) Study, TAM-163, PF-05230901, Cachexia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

44 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Dose

Arm Type

Experimental

Arm Description

6 treated, 3 placebos

Intervention Type

Drug

Intervention Name(s)

PF-05230901

Other Intervention Name(s)

TAM-153

Intervention Description

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

Intervention Name(s)

PF-05230901

Other Intervention Name(s)

TAM-163

Intervention Description

Single dose SC

Primary Outcome Measure Information:

Title

Incidence and severity of adverse events.

Time Frame

35 days

Title

Incidence and severity of clinical laboratory abnormalities.

Time Frame

35 days

Title

Mean change from baseline in vital signs.

Time Frame

35 days

Title

Mean change from baseline in 12-lead electrocardiogram (ECG) parameters.

Time Frame

35 days

Title

Incidence and severity of findings during the neurological examination.

Time Frame

35 days

Secondary Outcome Measure Information:

Title

Plasma concentrations

Time Frame

14 days

Title

Anti-drug antibodies

Time Frame

35 days

Title

Appetite and food consumption

Time Frame

13 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

Facility Information:

Facility Name

Pfizer Investigational Site

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06511

Country

United States

12. IPD Sharing Statement

Links:

URL

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B2291001&StudyName=A%20Study%20In%20Healthy%20Subjects%20Of%20Single%20Doses%20of%20PF-05230901%20Injected%20Under%20The%20Skin

Description

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

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